Nomenclature Department - 2002 · ANAES / Nomenclature Department / September 2002 11 • Tubal isthmus: the narrow medial third of the uterine tube, 3-6 cm long, internal diameter

Nomenclature Department - 2002

PROCEDURE ASSESSMENT DOSSIER:

Unilateral or bilateral gynaecological salpingoscopy [falloposcopy] by the uterine route, with or without: biopsy, specimen

Unilateral or bilateral gynaecological salpingoscopy [falloposcopy],

by laparoscopy, with or without: biopsy, specimen

(GENITOURINARY SYSTEM)

Falloposcopy

ANAES / Nomenclature Department / September 2002 2

This dossier was produced by Dr. Sun Hae Lee-Robin (Project Manager, Nomenclature Department, email: [email protected]), under the supervision of Dr. Marie-José Moquet (Head of the Nomenclature Department, email: [email protected]).

Secretarial services were provided by Khadia Dia, who also organised the working group meeting, email: [email protected]).

The literature search was carried out by Nathalie Dunia with the help of Sylvie Lascols, under the supervision of Rabia Bazi, Head of the Documentation Department.

Falloposcopy


CONTENTS SUMMARY OF DATA AND ADVICE.........................................................................................................................................3

SUPPORTIVE ARGUMENTS ........................................................................................................................................................9

I. INTRODUCTION ..........................................................................................................................................................10

II. BACKGROUND .............................................................................................................................................................10 II.1 ANATOMY OF THE FALLOPIAN TUBES..................................................................................................................... 10 II.2 PHYSIOLOGY OF THE FALLOPIAN TUBES................................................................................................................ 11 II.3 TUBAL DISORDERS.................................................................................................................................................... 11 II.4 DIAGNOSTIC METHODS FOR TUBAL DISORDERS.................................................................................................... 12

III. TECHNICAL DESCRIPTIO NS.................................................................................................................................13 III.1 GYNAECOLOGICAL FALLOP OSCOPY BY THE UTERINE ROUTE............................................................................ 13 III.2 SALPINGOSCOPY BY LAPAROSCOPY...................................................................................................................... 14

IV. LITERATURE SEARCH.............................................................................................................................................15 IV.1 INFORMATION SOURCES.......................................................................................................................................... 15 IV.2 SEARCH STRATEGY AND RESULTS......................................................................................................................... 15

V. SELECTION AND ANALYS IS OF STUDIES ......................................................................................................16 V.1 EFFICACY OF FALLOPOSCOPY BY THE UTERINE ROUTE....................................................................................... 16 V.2 EFFICACY OF SALPINGOSCOPY BY LAPAROSCOPY................................................................................................ 20 V.3 SAFETY AND COMPLICATIONS................................................................................................................................. 24

VI. FRENCH AND FOREIGN NOMENCLATURES ................................................................................................25

VII. POSTAL SURVEY.........................................................................................................................................................25 VII.1 UNILATERAL OR BILATERAL GYNAECOLOGICAL SALPINGOSCOPY [FALLOPOSCOPY], BY THE UTERINE ROUTE, WITH OR WITHOUT : BIOPSY, SPECIMEN............................................................................................................. 25 VII.2 UNILATERAL OR BILATERAL GYNAECOLOGICAL SALPINGOSCOPY [FALLOPOSCOPY], BY LAPAROSCOPY, WITH OR WITHOUT : BIOPSY, SPECIMEN........................................................................................................................... 26

VIII. ADVICE OF THE WORKING GROUP .................................................................................................................27 VIII.1 UNILATERAL OR BILATERAL GYNAECOLOGICAL SALPINGOSCOPY [FALLOPOSCOPY], BY THE UTERINE ROUTE, WITH OR WITHOUT : BIOPSY, SPECIMEN. ........................................................................................................... 27 VIII.2 UNILATERAL OR BILATERAL GYNAECOLOGICAL SALPINGOSCOPY [FALLOPOSCOPY], BY LAPAROSCOPY, WITH OR WITHOUT : BIOPSY, SPECIMEN........................................................................................................................... 28

ANNEXES ............................................................................................................................................................................................29 ANNEX 1. METHOD USED BY THE NOMENCLATURE DEPARTMENT TO ASSESS MEDICAL AND SURGICAL PROCEDURES....................................................................................................................................................................... 30 ANNEX II. WORKING GROUP MEMBERS...................................................................................................................... 32 ANNEX III. ARTICLES SELECTED ................................................................................................................................. 33 ANNEX IV. ARTICLES NOT SELECTED ......................................................................................................................... 35 ANNEX V. FALLOPOSCOPY SCORE .............................................................................................................................. 35 ANNEX VI. TYPES OF LESIONS RECORDED FALLOPOSCOPICALLY.......................................................................... 35 ANNEX VII. BROSENS AND PUTTEMANS CLASSIFICATION OF TUBAL LESIONS IDENTIFIED SALPINGOSCOPICALLY {PUTTEMANS 1998 221} .......................................................................................................... 36 ANNEX VIII. AFS SCORE (AMERICAN FERTILITY SOCIETY) ................................................................................... 36

REFERENCES ...................................................................................................................................................................................37

SUMMARY OF DATA AND ADVICE

Falloposcopy


Falloposcopy


SUMMARY OF DATA USED TO EVALUATE THE PROCEDURE

“Unilateral or bilateral gynaecological salpingoscopy [Falloposcopy], by the uterine route, with or without: biopsy, specimen”

(08.01.06.02 - JJQE001)

• Literature review Efficacy:

The published studies (level IV - feasibility studies) show that falloposcopy is a complex investigation, that there is no consensus as yet on method, and that it depends to a great extent on equipment which is still being developed and refined. Insufficient data are available to decide whether it is of any clinical benefit. F against

• Included in the French General Nomenclature of Professional Procedures Yes No F does not affect the decision

• Included in foreign nomenclatures Australia Belgium USA Quebec (not looked at) F in favour

• Postal survey of healthcare professionals - response level: 46/198 (23%) gynaecologists-obstetricians - median response: 5 F undecided

• Advice of the working group

The working group felt that the inclusion of this procedure was not justified, as there are insufficient data to decide whether it is of any clinical benefit.

Comments: the group commented that this descriptive heading was confusing, as the report refers to two separate procedures, and proposed the following change: “Unilateral or bilateral falloposcopy, by the uterine route”.

Fagainst

• Comments:

Falloposcopy


Advice on inclusion of a procedure in the CCAM1 based on scientific data, consultation of foreign nomenclatures and the opinion of healthcare professionals after examination of the dossier by the Scientific Council on 6 November 2002

Section: 08.01.06.02 CCAM code: JJQE001

Current CCAM descriptive heading: Unilateral or bilateral gynaecological salpingoscopy [Falloposcopy], by the uterine route, with or without: biopsy, specimen

Descriptive heading submitted for evaluation: Same

Descriptive heading proposed by ANAES: Unilateral or bilateral falloposcopy, by the uterine route

Against

Comments: This procedure was proposed more than 10 years ago to assess the quality of the tubal mucosa. However, in spite of its potential benefit, there is no consensus as yet on method, the equipment required is not yet of a high enough standard, and insufficient data are available to decide whether it is of any clinical benefit.

Procedure in the clinical research stage

Reassess in year(s)

In favour without recommendations

In favour with recommendations*

Specific or residual indications

Conditions under which procedure is to be performed

Requires specific training in the procedure (in addition to initial training)

To be performed in a specialist centre (staff, technical facilities)

Requires prospective data collection (efficacy, safety)

Reassess in year(s)

* Comments

1 Common Classification of Medical Procedures

Falloposcopy


SUMMARY OF DATA USED TO EVALUATE THE PROCEDURE

“Unilateral or bilateral gynaecological salpingoscopy [Falloposcopy], by laparoscopy, with or without: biopsy, specimen”

(08.01.06.02 - JJQC001)

• Literature review

Efficacy: The level of evidence for published studies is low (level IV), but they show that salpingoscopy is a useful complement to gynaecological laparoscopy for assessing the quality of the distal tubal mucosa.

F in favour

• Included in the French General Nomenclature of Professional Procedures Yes No

F does not affect the decision

• Included in foreign nomenclatures Australia Belgium USA Quebec (not looked at) F does not affect the decision

• Postal survey of healthcare professionals - response level: 42/198 (21%) gynaecologists-obstetricians - median response: 7 F in favour

• Advice of the working group - The working group felt that the procedure could be a useful complement to gynaecological

laparoscopy and decided in favour of its inclusion.

- Comments: the group commented that this descriptive heading was confusing, as the report refers to two separate procedures, and proposed the following change: “Unilateral or bilateral falloposcopy, by laparoscopy, with or without: biopsy, specimen.”

F in favour

• Comments:

Falloposcopy


Advice on inclusion of a procedure in the CCAM2 based on scientific data, consultations of foreign nomenclatures and the opinion of healthcare professionals after examination of the dossier by the Scientific Council on 6 November 2002

Section: 08.01.06.02 CCAM Code: JJQC001

Current CCAM descriptive heading: Unilateral or bilateral gynaecological salpingoscopy [Falloposcopy], by laparoscopy, with or without: biopsy, specimen

Descriptive heading submitted for evaluation: Same

Descriptive heading proposed by ANAES: Unilateral or bilateral salpingoscopy, by laparoscopy, with or without: biopsy, specimen

Against

Comments:

Procedure in the clinical research stage

Reassess in year(s)

In favour without recommendations

In favour with recommendations *

Specific or residual indications

Conditions under which procedure is to be performed

Requires specific training in the procedure (in addition to initial training)

To be performed in a specialist centre (staff, technical facilities)

Requires prospective data collection (efficacy, safety)

Reassess in year(s)

* Comments: This procedure could be a useful complement to gynaecological laparoscopy, for assessing the distal tubal mucosa. It requires specific training and a specific endoscope in addition to laparoscopic equipment.

2 Common Classification of Medical Procedures

Falloposcopy


SUPPORTIVE ARGUMENTS

Falloposcopy


I. INTRODUCTION

ANAES advises on whether medical and surgical procedures should be included in the Common Classification of Medical Procedures (CCAM) and, if so, under what conditions. The advice is based on the efficacy and/or safety of the procedures, and the conditions under which they should be performed. It does not include any decision on whether or not procedures should be eligible for reimbursement.

The method used by ANAES is based on:

- scientific data on the efficacy and/or safety of a procedure; - consultation of procedures included in other countries’ nomenclatures; - the opinion of professionals, solicited by a postal survey; - the opinion of professionals meeting as a working group.

The aim of this report is to decide whether the following procedures should be included:

- “Unilateral or bilateral gynaecological salpingoscopy [Falloposcopy], by the uterine route, with or without: biopsy, specimen”;

- “Unilateral or bilateral gynaecological salpingoscopy [Falloposcopy], by laparoscopy, with or without: biopsy, specimen”.

This assessment complements the assessment of two preliminary descriptive headings proposed for inclusion in 2000, namely “Falloposcopy (unilateral) (bilateral), for diagnostic purposes, by the laparoscopic route (with biopsy and/or specimen)” and “Falloposcopy (unilateral) (bilateral), for diagnostic purposes, by the transvaginal route (with biopsy and/or specimen)”.

II. BACKGROUND

The following background information on the anatomy and physiology of the Fallopian tubes, on tubal disorders and their diagnosis, and the technical descriptions of gynaecological falloscopy by the uterine route and salpingoscopy by laparoscopy is based on 6 articles (Annex III, Table 20).

II.1 Anatomy of the Fallopian tubes

The Fallopian tubes or uterine tubes or oviducts are two tubal structures 10-14 cm long, which extend the uterine horns to the region of the ovaries. They consist of smooth muscle covered by a subserous layer and a serous layer (peritoneal layer). The lumen is coated with a special form of epithelium for the transport of gametes and embryos. The proximal part of the tubes is narrower and thicker. The tubes broaden and become more elastic as they get further from the uterus. Each Fallopian tube consists of two orifices and four sections:

• Uterine orifice of the uterine tube (tubal ostium): opening of the tube into the uterine cavity, mean internal diameter 0.5-1 mm.

• Intramural portion (proximal part): the part of the tube within the wall of the uterus, which crosses the myometrium along a 1-3 cm straight or curving path, with an internal diameter of 0.2-0.5 mm.

Falloposcopy


• Tubal isthmus: the narrow medial third of the uterine tube, 3-6 cm long, internal diameter 2-3 mm. It extends from the uterine horn to the ampullary- isthmic junction. It consists of a thick muscle layer (a longitudinal layer and a circular layer) and a mucosa with four parallel folds.

• Tubal ampulla: 7-8 cm long. Its lumen increases as it approaches the infundibulum, with an internal diameter of 5-6 mm at the ampullary- isthmic junction and 1-2 cm in the external third of the ampulla. It has a very thin muscle layer, with a mucosa consisting of 4 or 5 major longitudinal plicae 4-5 mm in height subdivided into many secondary plicae. These plicae are coated with a single cylindrical ciliated epithelium and glandular cells.

• Fimbriated end or infundibulum: funnel-shaped portion of the tube, formed by 12-15 finger- like processes (fimbriae) of the mucosal layer, which open into the abdominal cavity and which sweep the surface of the ovary to which they are connected via one of these particularly long finger- like processes (the ovarian fimbria).

• Abdominal orifice of the uterine tube: opening of the uterine tube into the abdominal cavity, 1-2 cm in diameter.

II.2 Physiology of the Fallopian tubes

The Fallopian tubes have a number of different functions (1):

• Egg capture. The infundibular fimbriae sweep the ovary surface to pick up the egg. The movements take place by the action of the longitudinal muscle fibres of the fimbriae, particularly the ovarian fimbria, at ovulation. During ovulation, the movements of the cilia of the mucosa of the infundibulum are closely synchronised to guide the egg into the tube. The anatomical integrity of the infundibulum is crucial for egg capture.

• Transport of the gamete. After the egg has been picked up, it is transported towards the ampulla by the movements of the cilia, by tubal motility and by circulation of fluid in the tube. The same elements act in reverse to encourage the transport of spermatozoa to the ampulla. Propagation activity takes place in peristaltic waves towards the ampullary- isthmic junction from both ends of the tube at ovulation (peristaltic and antiperistaltic waves).

• Transport of the zygote. After fertilisation, the zygote stays in the ampulla for about three days, while awaiting the progestational phase which is favourable to its transfer into the uterus and for implantation. At the beginning of this phase, hormonal factors trigger its rapid progress towards the uterus. Movements of the cilia cause a flow from the infundibulum towards the isthmus, and unidirectional propagation of peristaltic waves throughout the whole tube towards the uterus. The tube maintains the environment required by the embryo for its continued development along the whole path right up until it arrives in the uterus.

II.3 Tubal disorders

Anatomical integrity and good function of the Fallopian tube are essential for egg capture, fertilisation and transport of the embryo to the uterus. Infection and inflammation, and the fibrosis they may cause, lead to anatomical and functional changes which make conception difficult or impossible. The inflammatory process destroys the ciliated mucosa and the muscle layer of the tube and creates adhesions. Scarring results in deciliation, agglutination of the fimbriae of the mucosa and fibrosis with either atrophy or hypertrophy of the tunica muscularis. This leads to deformation and partial or total destruction of one or more portions of the tube (uni-, bi- or multifocal lesions)

Falloposcopy


which causes infertility or sterility. Some types of obstruction can be corrected surgically, but it is not possible to repair deciliation or most tube malformations (1).

The Fallopian tubes can be affected by various disorders which cause tubal and peritoneal sterility. These account for 50-60% of cases of female sterility.

• Infectious disorders

- Bacterial infections originating in the female genital tract. These are the main cause of tubal lesions (approximately 80% of cases). They are sexually transmitted diseases, caused mainly by Chlamydia trachomatis, Neisseria gonorrhoea, and some species of Mycoplasma. In France, acute or subacute salpingitis causes pelvic inflammatory disease in 1.5% of women aged between 15 and 45. This may result in sterility or ectopic pregnancy. The risk of fertility-compromising sequelae is thought to be 11% after a first episode, 36% after a second episode and 75% after three or more episodes.

- Other pelvic disorders affecting the tubes.

- Appendicitis: inflammation of the peritoneum and subsequent fibrosis causing compression, deformation and major anatomical changes which can change the relative positions of tubes and ovaries, or in distal obstruction of the tubes (fibrosis covering the infundibulum);

- Tuberculosis: destruction of the tubal mucosa and fibrosis. • Non-infectious disorders

- Endometriosis (peritoneal inflammatory reaction) - Uterine leiomyomas (compression, obstruction of the tube lumen) - Complete or partial congenital agenesis and malformation of the Fallopian tubes - Any surgical trauma to the pelvis is likely to be an iatrogenic cause of tubal sterility.

II.4 Diagnostic methods for tubal disorders

Tubal lesions vary greatly in severity and type. A prognosis for the tubes has to be established before the most appropriate treatment strategy can be chosen for each type of lesion and each patient. A number of different diagnostic methods are available to assess tubal lesions and establish a prognostic score to help decide on treatment (2):

• Hysterosalpingography is a radiological examination with injection of contrast medium to visualise the internal configuration of the tubes. It is used to explore the uterine cavity, tube lumen, and tubal patency. Occasionally it reveals mucosal and tube wall abnormalities, but indirectly;

• Hysterosonography is an ultrasound examination of the uterus and tubes, in which fluid is injected via the cervix to create an acoustic window generating differing ultrasound waves. It is used to study the internal walls of these structures, and tube patency. It is a new technique, with little information available yet;

• Laparoscopy is used to visualise the external appearance of the tubes, and the general appearance of the pelvis. It may be completed by a methylene blue chromopertubation test to verify tubal patency. Exploratory laparoscopy may always be followed immediately by an endoscopic or microsurgical therapeutic procedure if necessary;

Falloposcopy


• Salpingoscopy is endoscopy of only the distal segment of the tubes (tubal ampulla and infundibulum), with a rigid or flexible endoscope of calibre 3 mm or more. It is performed during laparotomy, laparoscopy or fertiloscopy;

• Falloposcopy is endoscopy of the whole length of the tube (intramural portion, isthmus, ampulla and infundibulum) by the transvaginal route. It is performed during hysteroscopy or after tubal catheterisation with very thin flexible fibre-optic cables introduced into the tubes using either coaxial or linear everting catheters.

Hysterosalpingography and laparoscopy are the most common methods, and are generally considered to be complementary but they only allow indirect assessment of the tubal mucosa. Only salpingoscopy and falloposcopy allow direct visualisation of the lumen and the mucosa of the fallopian tubes. However, they do not provide information about the serous and muscular layers of the tube, or about the environment inside the tube (2).

III. TECHNICAL DESCRIPTIONS

III.1 Gynaecological falloposcopy by the uterine route

Falloposcopy is an endoscopic technique which allows direct visualisation of the lumen of the whole length of the tube, and which does not require general anaesthesia. Falloposcopy can be performed on an outpatient basis under sedation and analgesia.

The facilities required include a cold light source, a video circuit, a flexible endoscope and an irrigation system to distend the tube walls, and a control panel for zoom, focus, light intensity and brilliance. A small, 3.3 mm external diameter flexible hysteroscope with an additional working channel is also required (3).

A falloposcope is a very thin endoscope which can be moved from the vagina through the uterus to the inside of the tube lumen, from proximal to distal. The small diameter of fibreoptic cable used (0.45 mm external diameter) allows catheterisation of the whole length of the tube, from the tubal ostium as far as the infundibulum, but it has the major drawback of producing low-quality images (limited number of pixels), which may therefore be difficult to interpret (2).

There are two different types of system for falloposcopy:

(i) Coaxial system. A flexible hysteroscope is introduced through the neck of the uterus, without prior dilatation. After antibiotic prophylaxis, the tubal ostium is visualised with the hysteroscope during the follicular phase of the menstrual cycle. A flexible guidewire (diameter 0.3-0.8 mm) is introduced for 12-15 cm or until it encounters resistance by the working channel of the hysteroscope. A soft catheter (diameter 1.3 mm) is then introduced over the guidewire. The guidewire is withdrawn and the falloposcope with the camera attached is introduced under direct visualisation as far as the infundibulum. The tube is irrigated with a solution of ringer lactate using a syringe or pump. The tubal lumen is examined in retrograde manner. Twin videomonitoring delivers simultaneous images from the falloposcope and the hysteroscope (3,4).

(ii) Linear everting catheter. The tubes are catheterised using a linear everting catheter connected distally to a balloon. When pressure is applied, the balloon is everted and the internal part of the catheter is unrolled. The falloposcope is introduced inside the catheter for direct visualisation of the tubal ostium, without using a hysteroscope. The catheter is unrolled as far as required and a retrograde examination is performed. The tube is irrigated as above.

Falloposcopy


The system does not use a guidewire and is thought to cause fewer complications (trauma to the tube walls) than the coaxial system (4,5).

III.2 Salpingoscopy by laparoscopy3

It is an endoscopic technique performed during gynaecological laparoscopy, which allows direct exploration of the distal part of the tube only, i.e. of the ampulla and infundibulum.

• Laparoscopy

This procedure is carried out in a surgical environment, under general anaesthesia and using specific equipment. Tracheal intubation is used routinely (6). A needle is introduced through the abdominal wall, connected to a carbon dioxide (CO2) insufflator. Gas is insufflated into the abdomen to create pneumoperitoneum up to an intra-abdominal pressure of 15 mmHg. The pneumoperitoneum provides good visualisation and allows the identification of organs inside the abdomen. Three incisions are made: (i) a 1-cm incision at umbilical level to introduce a laparoscope connected to a video camera and light source (through a trocar), (ii) an incision fo r an irrigation-suction system, (iii) an incision to insert surgical instruments (6).

The macroscopic anatomy of the external tube wall can be examined directly along the whole length of the extrauterine section for inspection of the fimbria of the infundibulum and the anatomical relationship of the infundibulum with the ovary and pelvic peritoneum. Tubal patency can also be explored by instilling methylene blue via a catheter placed in the uterine cavity.

At the end of the procedure, the pneumoperitoneum is desufflated and the patient is extubated once spontaneous respiration has resumed and consciousness returned. The patient must be transferred to a recovery room. The postoperative period is generally uneventful. Transit and oral nutrition are resumed at an early stage. Postoperative pain is generally mild. The patient is generally discharged from hospital the next day (6).

• Salpingoscopy

A flexible or rigid endoscope and an irrigation system for distending the tube walls are needed, in addition to the specific equipment required for laparoscopy. The diameter of the endoscope used (external diameter 1.2-2.8 mm) provides high-quality images for interpretation during the examination and for retranscription of data (4). The salpingoscope consists of four parts (7):

(i) a metal sheath with centimetre markings, which can be connected to the laparoscope and irrigation system;

(ii) an obturator which fits into the metal sheath; (iii) the salpingoscope itself; (iv) a cover to protect the salpingoscope. An atraumatic forceps is introduced through a second suprapubic incision to grasp the margin of the serous layer of the infundibulum and carefully align the ampullary segment along the visual axis of the laparoscope. The obturator is introduced and the forceps then holds the tube with the metal sheath and its obturator. This is replaced by the salpingoscope in its protective cover, which is introduced as far as the ampullary-isthmic junction, or until a point of resistance is encountered. The lumen is distended by irrigation with Ringer lactate solution to allow better visualisation of the mucosa and its folds. A retrograde inspection is performed. Inspection begins at the most proximal

3 This examination has also been called tuboscopy or fimbrioscopy. Sometimes the term “falloposcopy by laparoscopy” is used but it does not correspond to descriptions in the literature. Falloposcopy has been described only by the uterine route, while salpingoscopy has been described by laparoscopy, by laparatomy, or during fertiloscopy, and never by the uterine route.

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part of the tube towards the ampulla, at the most distal part, followed by the infundibulum. The laparoscope is used to control the position and movements of the salpingoscope (4,7).

IV. LITERATURE SEARCH

IV.1 Information sources

Databases consulted: - Medline (National Library of Medicine, USA) - Pascal - Cochrane Library (UK) - National Guideline Clearinghouse (USA) - HTA Database (International Network of Agencies for Health Technology Assessment -

INAHTA)

IV.2 Search strategy and results

A search strategy was constructed for each subject using either thesaurus terms (MESH headings) or free text (terms in the title or summary). These were combined in as many stages as necessary using the operators “AND” “OR” “NOT”. They were also combined with the headings for type of trial (Table 1).

Table 1. Literature search strategy and results Type of study Terms used Period Results* Guidelines 1991-2002 M : 1 Equation 1 [Fallopian Tube Diseases / Diagnosis OR Fallopian Tube Diseases /

Radiology OR Infertility Female / Diagnosis OR Fallopian Tubes OR Infertility, Female / Diagnosis] AND [Endoscopy OR Salpingoscop (free text) OR Falloposcop (free text) OR Endoscop (free text)]

AND Equation 2 Practice Guideline (s) (heading, type of document) OR Guideline(s)

(heading, type of document, title) OR Health Planning Guidelines OR Recommendation(s) (titre) OR Consensus Development Conferences (heading, type of document) OR Consensus Development Conferences, NIH (heading, type of document t) OR Consensus Conference(s) (title, summary) OR Consensus Statement(s) (title, summary)

Literature reviews 1991-2002 M : 2 Equation 1 AND Equation 3

Meta-Analysis (title, summary, title) OR Review Literature (title, summary) OR Systematic Review (title) OR Review of Effectiveness (title)

Table 1. Literature search strategy and results (cont'd) Type of study Terms used Period Results* Level I studies 1991-2002 M : 27 Equation 1 AND

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Equation 4

Controlled Clinical Trial(s) (heading, type of document) OR Randomized Controlled Trial(s) (heading, type of document) OR Single-Blind Method OR Single Blind Procedure OR Double-Blind Method OR Double Blind Procedure OR Random Allocation Randomization OR Random (titre) OR Controlled Study OR Major Clinical Study OR Cross-Over Studies OR Crossover Procedure

Searches on title No limit M : 59 Equation 5 Salpingoscop* (title) OR Falloposcop* (title) Articles in French 1991-2002 P : 14 Equation 6

Falloposcopie (title, heading) OR Salpingoscopie (title, heading) OR [Trompe Fallope AND (Endoscopie OR Laparoscopie OR Exploration OR Hysteroscopie)]

*Number of references in M= Medline, P =Pascal.

V. SELECTION AND ANALYSIS OF STUDIES

A first selection by title and summary produced 30 articles, each of which was allocated a level of scientific evidence (see Annex 1). Of these 30 articles, 23 were used for this report (Annex III, Tables 17-20) and 7 were rejected for the reasons outlined in Annex IV (Table 21).

V.1 Efficacy of falloposcopy by the uterine route

Nine of the 23 studies referred to falloposcopy by the uterine route (5 studies used the coaxial system and 4 the linear everting catheter system) (Tables 2 and 3). These were feasibility studies which mainly investigated tube catheterisation and visualisation rates. Falloposcopy was performed: - on an outpatient basis with simple sedation and analgesia in one trial (5) - at the same time as laparoscopy, in a surgical environment and under general anaesthesia,

because of the novel and experimental nature of the method, in 8 trials. Falloposcopy was carried out in women with a history of primary or secondary infertility of tubal or unexplained origin, discovered by previous hysterosalpingography and/or laparoscopy.

• Technical problems and failures

Failure to catheterise the tubal ostium. Failure rates were 0-38% (coaxial system) and 5-11% (linear everting catheter system) (Tables 2 and 3). The main reasons for failure were difficulty or impossibility in identifying the tubal ostium, fibrosis and/or stenosis, or an advanced stage of endometrial proliferation. Other less common reasons were hysteroscope dysfunction, accentuated uterine flexion, intracavitary disease and wall perforation during attempted catheterisation. One team included as a failure any cancelled examination of a contralateral tube because the time allowed for the procedure, i.e. 60 minutes, had been exceeded (8) (Table 2).

Other technical problems precluding examination. Technical failure is defined as inability to advance the falloposcope in the tubal lumen in the absence of any visible obstruction (3). The technical failure rate was 7-53% for the coaxial system (3,8-11) and 0-7% for the linear everting catheter system (5,12-14) (Tables 2 and 3). The main reasons for failure were:

- equipment fault or failure (guidewire twisted, catheter tip damaged, or dysfunction of the hysteroscope, falloposcope, or irrigation system);

- tortuous path through the tube, or zones where the lumen narrowed, particularly in tubes with external adhesions;

- insufficient irrigation, causing the lumen to be reflected and resulting in unusable images;

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- the catheter tip being obstructed by the wall; - complications such as wall perforation or dissection; - operator’s lack of experience at the start of the learning curve, particularly in crossing the

narrowest parts of the tube. Tubal disease itself (spasm, obstruction and intraluminal adhesions) may also prevent advancement of the falloposcope and full visualisation of the tubal lumen downstream of the lesion (8,10,11). In extreme cases, when tube obstructions are located very proximally, falloposcopy cannot be performed (2).

• Interpreting examination results

Kerin et al. have proposed a score to determine the location, nature and extent of the tubal disorder (9) (Annex V) and have identified several types of lesions (Annex VI). However, high-quality images have to be obtained before the score can be used and lesions identified accurately. High-quality images were obtained in 24-66% of examinations in the two trials providing this information (Table 2). In the trial by Lundberg et al., none of the examinations resulted in high-quality images allowing continuous and complete visualisation of the tubal mucosa (8).

• Learning curve

The number of examinations needed to master the technique was put at 10, 30 or even 100 if unambiguous interpretation of images had to be achieved (8,9,14). In addition, the wide variation in success rates in an 18-centre trial (33-100%) shows that the technique is not yet widespread and has not generally been mastered (11).

• Comparing falloposcopy with hysterosalpingography and/or laparoscopy

Only 3 trials have performed such comparisons (3,9,13) (Table 4). Discrepancies between abnormal hysterosalpingography and/or laparoscopy results and a normal falloposcopy results could be due to spasm, or to a clot of mucous which could momentarily prevent the passage of contrast medium or methylene blue (false positives). Conversely, when tubes which appear healthy on hystero-salpingography and/or laparoscopy are found to be diseased on falloposcopy, this could be a false negative result, particularly with regard to minor lesions or alterations which are probably hard to detect in the standard examinations. There is no gold standard examination for assessing tubal mucosa. Falloposcopy is a complementary rather than alternative examination which is still under development and which has not yet been validated. The results of the three examinations cannot therefore be compared in terms of sensitivity and specificity, or predictive value.

In conclusion, falloposcopy is a complex diagnostic examination. Only feasibility studies are available. Data vary greatly. The technique relies on equipment still being developed and perfected. The learning curve is rather long. Despite its potential (the obvious benefit of an examination directly visualising the tubal mucosa), data on its benefit in current practice are inconclusive.

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Table 2. Falloposcopy feasibility studies – coaxial system

Lead author (year)

Number of tubes [Population]

Mean age (yrs) (range)

Failure to catheterise TO N [%]

Technical failure* N [%]

Tubes visualised † N [%]

Examinations with high-quality images

N [%]

Kerin, 1990 (3)

75 [44]

NA (29-41)

4 [5]

8 [11]

63 [84]

NA

Kerin, 1992 (9)

121 [75]

NA (24-44)

0 9 [7]

112 [93]

NA

Pennehouat, 1993 (10)

130 [66]

29 (22-37)

20 [15]

69 [53]

41 [32]

NA

Lundberg, 1998 (8)

83 [43]

31,3 (22-40)

32 ‡ [38]

8 [10]

43 [52]

20 [24]

Rimbach, 2001 (11)

639 [367]

32 (18-40)

39 [6]

70 [11]

530 [83]

423 [66]

TO: tubal ostium; * impossible to advance the falloposcope in the lumen of the tube in the absence of any visible obstruction; † visualised entirely or up to an obstruction; NA: not available; ‡ including 19 contralateral tubes not examined because the time allowed for the procedure (60 minutes) was exceeded.

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Table 3. Falloposcopy feasibility studies – linear everting catheter system *

Lead author (year)

Number of tubes [population]

Mean age (yrs) (range)

Failure to catheterise TO N [%]

Technical failure* N [%]

Tubes visualised † ‡ N [%]

Scudamore, 1992 (5)

42 [21]

NA 4 [10]

3 [7]

35 [83]

Bauer, 1992 (12)

21 [17]

NA 1 [5]

NA 20 $ [95]

Venezia, 1993 (13)

35 [18]

NA 23-35

4 [11]

0 31 [89]

Dechaud, 1998 (14)

145 [75]

31 (19-40)

8 [5.5]

NA 112 [77]

* No study gave data on image quality; TO: tubal ostium; † impossible to advance the falloposcope in the tube lumen in the absence of any visible obstruction; NA: not available; ‡ visualised entirely or up to an obstruction; $ including 15 healthy tubes for which the reasons for incomplete visualisation were not given.

Table 4. Studies of comparison of results of falloposcopy and hysterosalpingography (HSG) or laparoscopy Kerin, 1990 (3) Kerin, 1992 (9) Venezia, 1993 (13)

Results of falloposcopy

Number of tubes

Discrepancy with HSG or laparoscopy – N [%]

Number of tubes *

Discrepancy with HSG and laparoscopy – N [%]

Number of tubes

Discrepancy with HSG N [%]

Normal 28 12 [43] 52 NA 17 7 [41]

Abnormal 35 4 [11] 60 NA 14 5 [36]

Total tubes visualised

63 16 [25] 112 52 [46] 31 12 [39]

HSG: hysterosalpingography; * all tubes were abnormal on hysterosalpingography and laparoscopy; not applicable.

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V.2 Efficacy of salpingoscopy by laparoscopy

Of the 23 studies, 6 were case series in which salpingoscopy was performed during laparoscopy for investigating infertility, or during microsurgery to treat adhesions or distal occlusion. Results for salpingoscopy were compared with those for laparoscopy (15-20) (Table 5). Results were graded: - according to the Brosens and Puttemans classification for salpingoscopy (grades I and II classed

as normal, and grades III to V abnormal) (see Annex VII) (7), - using AFS scores (American Fertility Society) for adhesions or distal occlusion for laparoscopy

(see Annex VIII) (21). In 2 of the 6 studies, microsurgery and salpingoscopy were performed by laparotomy or laparoscopy, but the data were presented globally, with no distinction made between the two surgical techniques (16,19). • Identifying intraluminal abnormalities in women with normal tubes

Salpingoscopy complements laparoscopy as it allows a full examination of the external appearance of the tube and tube patency (chromopertubation test) by direct visualisation of the tube lumen as far as the ampulla. It could thus be useful in identifying women with intraluminal abnormalities among women with normal tubes or with minor abnormalities revealed by laparoscopy. The proportion of such cases was 25-44% in women with unexplained infertility or non-occlusive adhesions on laparoscopy (15-20) (Table 5). It was higher (55-80%) in women with distal occlusive disease, suggesting that the tubal mucosa is damaged more often in this type of disorder (16,19) (Table 5).

• Intrauterine pregnancy rates

Intrauterine pregnancy rates were analysed in 5 of the 6 studies in women classified by salpingoscopy or laparoscopy results (scores for the least affected tube) (16,18-20,22) (Tables 6 and 7). The women were followed up for 14-49 months after diagnostic examination or microsurgery. The pregnancy rate was significantly higher in women in whom salpingoscopy revealed normal (classes I-II) rather than abnormal (classes III-V) mucosa (Table 6). There was no difference in pregnancy rate between the various groups of women classified by laparoscopy score, i.e. with normal or very minor abnormalities versus moderate abnormalities (Table 7). The extrauterine pregnancy rate was 0-7%, with no significant difference in distribution between the various salpingoscopy or laparoscopy grades. These results confirm the importance of assessing the tubal mucosa to establish a prognosis for conception and for possible surgical treatment.

• Other points

In distal obstructive disease such as hydrosalpinx, the distal end of the tube has to be opened befo re the examination can be performed. Repair surgery therefore has to be completed before its prognosis can be established (2).

A single study gave the number of salpingoscopies which could not be performed (60/452 or 13%), but did not give reasons (19).

In conclusion, salpingoscopy complements gynaecological laparoscopy. It appears to be useful for assessing the quality of the distal tubal mucosa, which is an important factor in deciding on treatment for women with infertility.

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Table 5. Comparison of results of salpingoscopy and laparoscopy

Lead author (Year)

Number of tubes

Mean age (yrs)

(range)

Indication Abnormal tubes found - N [%] ______________________________________________

Salpingoscopy* Laparoscopy†

False negative laparoscopies ‡

N [%]

Marconi, 1992 (15)

84 [42]

ND Investigation of infertility 37 [44]

68 [81]

4 [25]

Marana, 1995 (16)

41 [29]

group 1

30 (22-38)

During microsurgery to treat distal tubal adhesions

11 [27]

28 [68]

4 [31]

50

[26] group 2

30 (22-38)

During microsurgery to treat distal occlusion

34 [68]

23 [46]

15 [55]

Antony, 1996 (17)

188 [124]

NA (20-42)

Investigation of infertility 71 [38]

37 [20]

39 [26]

Surrey, 1996 (18) 91

[55] 34

(23-44) Investigation of infertility 49

[54] 40

[44] 18

[35]

De Bruyne, 1997 (19)

228 [130]

group 1

NA During microsurgery to treat distal tubal adhesions

115 [50]

120 [53]

47 [43]

164

[96] group 2

NA During microsurgery to treat distal occlusion

153 [93]

144 [88]

16 [80]

Marchino, 2001 (20)

174 [91]

31 (21-44)

Investigation of infertility 80 [46]

103 [59]

31 [44]

* Grades III-V according to Brosen and Puttemans score (see Annex 3); † mild to moderate adhesions or moderate to severe occlusion according to AFS scores (see Annexes 4A and 4B) ; NA : not available; ‡ tubes presenting major mucosal lesions on salpingoscopy in women with very minor or minor lesions on laparoscopy.

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Table 6. Pregnancy rate according to salpingoscopy results*

Pregnancy rate N pts [%]

Lead author (Year)

Population†

Mean age (yrs)

(range)

Indication Follow-up (mos)

Intrauterine pregnancies

(N) Class I-II Class III-V

p

Marana, 1995 (16)

29 group 1

30 (22-38)


49 16‡ 73 [22]

0 [7]

<0.01

26

group 2 30

(22-38) During microsurgery to treat distal occlusion

49 7‡ 64 [11]

0 [15]

<0.001

Surrey, 1996 (18) 42 34

(23-44) Investigation of infertility 14 8 39

[18] 4

[24] <0.01


90 group 1


42 44 64 $ [52]

37 [38]

<0.05

73

group 2 NA During microsurgery to treat

distal occlusion 42 19 79 $

[7] 23

[66] <0.01

Marana, 1999 (22) 24

group 1 32

(24-40) During microsurgery to treat distal tubal adhesions

33 12‡ 70 [17]

0 [7]

<0.01

27

group 2 32

(24-40) During microsurgery to treat distal occlusion

33 7‡ 60 [11]

0 [16]

<0.001

Marchino, 2001 (20)

91 [174]

31 (21-44)

Investigation of infertility 18 17‡ 28 [60]

0 [31]

<0.05

And

* according to Brosens and Puttemans classification: I-II: normal; III-V: abnormal (see Annex3); † women followed-up until pregnancy or end of study; ‡ full-term pregnancy; NA: not available; $ cumulative pregnancy rate.

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Table 7. Pregnancy rate by laparoscopy results*

Lead author (Year)

(Popula-tion†)

Mean age (yrs)

(range)

Indication Follow-up (mos)

Intrauterine pregnancies

(N)

Pregnancy rate N pts [%]

p

Minor/Mild Moderate/Severe

Marana, 1995 (16)

29 group 1

30 (22-38)


49 16‡ 53 [19]

60 [10]

NS

26

group 2

30 (22-38)


49 7‡ 33 [18]

12 [8]

NS

Surrey, 1996 (18)

42 34 (23-44)

Investigation of infertility 14 8 27 [22]

10 [20]

NA


90 group 1


42 44 58$ [71]

32$ [19]

NS

73

group 2 NA During microsurgery to treat

distal occlusion 42 19 50$

[10] 25$ [63]

NS

Marana, 1999 (22)

24 group 1

32 (24-40)


33 12‡ 45 [11]

54 [13]

NS

27

group 2

32 (24-40)


33 7‡ 30 [10]

24 [17]

NS

Marchino, 2001 (20)

91 [174]

31 (21-44)

Investigation of infertility 18 17‡ 27 [41]

12 [50]

NS

*According to AFS (American Fertility Society) scores for adhesion or distal occlusive disease (see Annexes 4A and 4B); † women followed-up until pregnancy or end of study; ‡ full-term pregnancies; $ cumulative pregnancy rate; NS: difference not significant; NA: not available

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V.3 Safety and complications

• Falloposcopy by the uterine route

The most common complication was perforation with oedema and/or dissection of the tube wall by the falloposcope, with no subsequent major consequences and without any need for intervention. The complication rate was 0-5% during diagnostic falloposcopy but as high as 22% during tube repair by falloposcopy (Table 8).

Table 8. Perforation and/or dissection of the tube wall (falloposcopy by the uterine route)

Rate

N % Kerin et al., 1990 (3) 0/71 0 Kerin et al., 1992 (9) 6/27 22* Pennehouat et al., 1993 (10) 1/110 0.9 Lundberg et al., 1998 (8) 1/43 2.3 Dechaud et al., 1998 (14) 7/150 5 Rimbach et al., 2001 (11) 24/639 3.7

* During tube repair

In addition, Pennehouat et al. reported three uterine perforations and one broken falloposcope during the examination, in their series of 110 tubes examined (10). No other long-term complications were reported in cases followed up to 12-24 months (3,9,14).

• Salpingoscopy by laparoscopy

The most common complication rate was tube wall perforation by the salpingoscope. The rate varied from 0.4 to 1% (Table 9).

Table 9. Perforation of the tube wall (salpingoscopy by laparoscopy)

Rate

N % Marconi et al., 1992 (15) 1/84 1

Heylen et al., 1995 (23) 1/232 0.4

Antony et al., 1996 (17) 2/188 1

Mucosal tearing (1/84 – 1 %) (15) and bruising of the serous membrane by forceps (1/232 – 0.4 %) (23) were also described. No complications were reported in the other studies (16,18-20,22).

No complications related to laparoscopy or to general anaesthesia were reported.

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VI. FRENCH AND FOREIGN NOMENCLATURES

Neither of the two procedures is included in the Nomenclature Générale des Actes Professionnels (NGAP) (General Nomenclature of Professional Procedures). However, the NGAP includes procedures used to perform salpingoscopy by laparoscopy:

- “laparoscopy” - “laparoscopy with biopsy or therapeutic procedure” - “any intervention concerning the female reproductive organs (by the upper route)” - “panoramic hysteroscopy and microhysteroscopy with use of distension (gas or fluid)”, which

is one of the stages in falloposcopy by the uterine route. Only the Australian nomenclature includes falloposcopy by the uterine route. The United States and Belgian nomenclatures do not include any of the procedures assessed but do include diagnostic laparoscopy (Table 10).

Table 10. Procedures in foreign nomenclatures

Nomenclature Code Descriptive heading American (CPT 2002) 49321 Laparoscopic biopsy of the ovary or fallopian tube Australian (MBS 2001) 35710

30390 30391

Falloposcopy, unilateral or bilateral, including hysteroscopy and tubal catheterization Laparoscopy, diagnostic Laparoscopy with biopsy

Belgian (2000) 432493

432504 Diagnostic laparoscopy without biopsy including pneumoperitoneum

432692 432703

Laparoscopy for tubal procedure, including pneumoperitoneum

VII. POSTAL SURVEY

A total of 198 gynaecologist/obstetricians were contacted, 92 of whom practised in centres approved to carry out assisted reproduction.

VII.1 Unilateral or bilateral gynaecological salpingoscopy [falloposcopy], by the uterine route, with or without: biopsy, specimen

The response rate was 23% (46/198); 13 professionals were against including the procedure, 19 undecided, and 14 in favour. The median response (score of 5) was ‘indecision’ (Table 11). Only 6 respondents performed or ordered the procedure and they tended not to be in favour of inclusion. The opinion of the remaining 40 respondents varied greatly (score from 1 to 9), indicating that they did not understand the descriptive heading or had varying levels of knowledge of the procedure.

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Table 11. Results of the postal survey (scores)

Number of respondents per score (total 46)

DO NOT INCLUDE UNDECIDED INCLUDE Score 1 2 3 4 5 6 7 8 9

Performs 1 1 1 Orders 3 Neither performs nor orders the procedure

6 1 5 4 13 1 5 3 2

7 1 5 5 13 1 8 3 3 Median = 5

The main indication proposed (8 respondents) was "assessment of the quality of the tubal mucosa during investigation of tubal or unexplained sterility and possible removal of tubal obstruction (phimosis, polyps)". According to 3 respondents, the procedure is a diagnostic and therapeutic procedure still in the research stage, its feasibility relies heavily on special equipment (very small endoscopes), and its precise indications have yet to be defined. Two other respondents stated that the examination was without benefit or was of questionable benefit. Respondents’ comments are summarized in Table 12.

Table 12. Results of the postal survey (comments)

Item Number of respondents who cited the item

Complications and side-effects reported • Tubal lesion or perforation 5 • Infection 6 • Pelvic pain 2 Alternative techniques proposed • Hysterosalpingography 13 • Hysterosalpingography with selective salpingography 4 • Salpingoscopy by laparoscopy 10 • Fertiloscopy 2 Conditions for performing the procedure • To be used in the context of a research protocol 22 • To be used in the context of an operating or follow-up protocol 12 • To be used and recorded in a registry 13 • Requires specific technical facilities (equipment, staff infrastructure) 29 • Requires special training in the procedure

29

VII.2 Unilateral or bilateral gynaecological salpingoscopy [falloposcopy], by laparoscopy, with or without: biopsy, specimen

The response rate was 21%; 6 professionals were against including the procedure, 11 undecided and 25 in favour. The median response (score of 7) was in favour of inclusion (Table 13). The 15 professionals who performed or ordered the procedure were on the whole in favour of including it. Of the remaining 27, only 4 were against its inclusion and 9 were undecided.

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Table 13. Results of the postal survey (scores)

Number of respondents per score (total 42)


Performs 1 1 2 3 3 Orders 1 1 2 1 Neither performs nor orders the procedure

3 1 3 5 1 10 1 2

Insufficient information 1 4 1 1 4 6 1 13 6 6 Median = 7

The main indication proposed (19 respondents) was assessment of the quality of the distal tubal mucosa, during workup before tubal or unexplained infertility and possible removal of obstruction (phimosis, polyps, adhesions, synechiae) or tuboplasty. Three professionals reported that the examination was of no benefit or that its indications had yet to be defined. Respondents’ comments are summarized in Table 14.

Table 14. Results of the postal survey (comments)

Item Number of respondents who cited the item

Complications or side-effects reported • Complications or side effects related to laparoscopy 15 • Tubal lesions or perforations 7 • Complications or side effects related to general anaesthesia 1 • Infection 1 • Abdominal pain 1 Alternative techniques proposed • Hysterosalpingography 8 • Falloposcopy by the uterine route 4 • Laparoscopy with methylene blue 2 • Fertiloscopy 2 Proposed conditions for performing the procedure • To be used in the context of a research protocol 12 • To be used in the context of an operating or follow-up protocol 10 • To be used and recorded in a registry 9 • Requires specific technical facilities (equipment, staff infrastructure) 26 • Requires special training in the procedure. 25

VIII. ADVICE OF THE WORKING GROUP

The working group consisted of 11 professionals (gynaecologists/obstetricians) (Annex II).

VIII.1 Unilateral or bilateral gynaecological salpingoscopy [falloposcopy], by the uterine route, with or without: biopsy, specimen.

The working group found this descriptive heading confusing as it refers to two separate procedures:

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- Falloposcopy which is performed by the uterine route and not by laparoscopy, during which no biopsy nor specimen is taken.

- Salpingoscopy which is normally performed by laparoscopy and which is not performed by the uterine route.

They proposed a new heading “Unilateral or bilateral falloposcopy, by the uterine route” but voted against inclusion (median score of 2; Table 15). Their opinion was that, although the procedure had been proposed over 10 years ago to assess the quality of tubal mucosa and despite its potential benefit, it was still being developed and validated, the equipment required was not yet very effective, and insufficient data were available to decide whether it is of any clinical benefit.

Table 15. Working group scores

Number of working group members per score (total 11)


1 6 1 1 2 Median = 2

Their final advice was against including the procedure.

VIII.2 Unilateral or bilateral gynaecological salpingoscopy [falloposcopy], by laparoscopy, with or without: biopsy, specimen

The working group considered the descriptive heading inadequate for the same reasons as above. In addition, the term "gynaecological" was considered to be redundant. The new proposed heading was : “Unilateral or bilateral salpingoscopy by laparoscopy, with or without: biopsy, specimen”.

The median score of 7 was in favour of including this procedure (Table 16). The working group considered the procedure a useful complement to gynaecological laparoscopy in assessing the distal tubal mucosa.

Table 16. Working group scores

Number of working group members per score (total 11)


10 1 Median = 7

The final advice of the working group was “favourable with recommendations”. The recommendations concerned the conditions under which the procedure is to be performed: - the procedure requires a specific endoscope in addition to laparoscopic equipment - specific training in carrying out the procedure is required in addition to initial training.

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ANNEXES

Falloposcopy


ANNEX 1. METHOD USED BY THE NOMENCLATURE DEPARTMENT TO ASSESS MEDICAL AND SURGICAL PROCEDURES

The method proposed by ANAES for advising on CCAM procedures is based on:

- scientific data on the efficacy and/or safety of procedures; - consultation of procedures included in other countries’ nomenclatures; - the opinion of professionals, solicited by a postal survey; - the opinion of professionals meeting as a working group.

1. Scientific data on the efficacy and/or safety of procedures

A thorough literature search is performed by a systematic interrogation of the medical and scientific databases over a period appropriate for each subject. Depending on the subject, other databases may also be searched. A stage common to all studies is a systematic search for clinical practice guidelines, consensus conferences, systematic reviews, meta-analyses and other assessment studies already published on a national and international basis. All relevant Internet sites (government agencies, learned societies, etc.) are explored. Documents not accessible via the conventional information distribution circuits (grey literature) are searched by all means possible. Decrees, orders and circulars published by the Ministry of Health which could be related to the subject are also consulted. The original searches are updated right up to the end of the project. References cited in the articles analysed are used to find articles not identified during the search of the various information sources. Finally, professionals taking part in the postal survey and working groups sent articles from their own document collections. The languages used are French and English. The “Literature Search” section gives details of sources consulted and of the search strategy used for each procedure or group or procedures.

Each article is reviewed according to the principles of critical appraisal of the literature and classified by level of scientific evidence (ANAES classification). An appraisal instrument is used to assess quality of study design and level of scientific evidence. Articles are included or rejected according to these criteria.

Level of scientific evidence (Levels I to IV)

I High powered randomised controlled trials (meta-analyses and systematic revised of all), decision analyses.

II Low powered randomised controlled trials, or non-randomised controled trials, cohort studies.

III Case-control studies.

IV Retrospective studies, case series, descriptive epidemiological studies and controlled trials with bias.

2. Consultation of procedures included in other countries’ nomenclatures

Nomenclature data from four countries are taken into account.

Three of these nomenclatures have a similar structure to that of the CCAM, in which codes and prices are allocated for each procedure:

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- the “Current Procedural Terminology” (CPT) in the United States; - the “Medicare Benefits Schedule Book” (MBS) in Australia; - the “nomenclature des prestations de santé” (nomenclature of healthcare services) published by

the Institut National d'Assurance Maladie-Invalidité in Belgium. In addition, the list of the 160 procedures subject to special reimbursement conditions by the Swiss health insurance system is used.

These nomenclatures are searched for entries relating to the procedure being assessed (same or similar descriptive heading). Any entries found are recorded and used as supportive information for inclusion of the procedure.

3. The opinion of professionals solicited by postal survey (formal expert consensus)

An evaluation form for each procedure is sent by post to professionals from different specialties, working in different types of practice (university hospitals, general hospitals, or independent practice) and different geographical areas. The minimum panel size is 100. Each professional scores their opinion on a scale from 1 to 9 (1,2,3: procedure not to be included; 4,5,6,: no decision; 7,8,9: procedure to be included). The median, extremes and a summary of responses are then returned to them for a second round of voting.

4. The opinion of professionals meeting as a working group (formal expert consensus)

Professional associations and societies are consulted to find out what work has been done on the procedures and who might take part in a working group of about fifteen professionals (same profile criteria as in §3). The group meets once to examine all available results (literature analysis, comparisons with other nomenclatures, postal survey). Its opinion is obtained by a formal expert consensus method (a first vote followed by a discussion and a final vote). After discussion, the group votes on its opinion using the same scale from 1 to 9.

An ANAES project manager coordinates all the work and oversees the application of this 4-step method. Once the Scientific Council (Evaluation Section) has examined the dossiers, ANAES gives its advice on the procedures. This advice is based on the data in the literature, comparisons with other countries and the opinion of healthcare professionals.

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ANNEX II. WORKING GROUP MEMBERS

The working group met on 12 September 2002. Each member validated the group’s advice as given in this report.

Dr. Joëlle Belaisch-Allart Gynaecologist/Obstetrician

Jean-Rostand Hospital Sèvres (92)

Dr. Georges-Fabrice Blum Gynaecologist/Obstetrician

Medical Practice Mulhouse (68)

Dr. Edgard Cornier Surgeon/Obstetrician

Clinique de la Muette Paris (75)

Dr. Hervé Dechaud Gynaecologist/Obstetrician

Arnaud de Villeneuve University Hospital Montpellier (34)

Dr. Jean-Michel Dreyfus Gynaecologist/Obstetrician

Medical Practice Lyon (69)

Dr. Marc Durand-Réville Gynaecologist/Obstetrician

L’Archet II Hospital Nice (06)

Professor Hervé Fernandez Gynaecologist/Obstetrician

Antoine Béclère Hospital Clamart (92)

Professor Philippe Judlin Gynaecologist/Obstetrician

Nancy University Hospital Regional Maternity Service Nancy (54)

Dr. Florence Lestrade Gynaecologist/Obstetrician

Sainte-Croix Hospital Metz (57)

Dr. Christophe Poncelet Gynaecologist/Obstetrician

Bichat University Hospital Paris (75)

Dr. Gérard Schweitzer Gynaecologist/Obstetrician

Le Havre Hospital Montivilliers (76)

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ANNEX III. ARTICLES SELECTED

Of the 30 articles retrieved, 23 were used to produce this report (Tables 17-20).

Table 17. Articles selected for critical appraisal of falloposcopy by the uterine route (co-axial system)

Year Lead author (Country) Study type Level of evidence 1990 Kerin (3)

(USA) Case series IV

1992 Kerin (9)


1993 Pennehouat (10)

(France/Venezuela) Case series IV

1998 Lundberg (8)

(Sweden) Case series IV

2001 Rimbach (11)

(Germany) Case series IV

Table 18. Articles selected for critical appraisal of falloposcopy by the uterine route (linear everting catheter system)

Year Lead author (Country) Study type Level of evidence 1992 Bauer (12)

(Germany/USA) Case series IV

1992 Scudamore (5)

(UK/Canada) Case series IV

1993 Venezia (13)

(Italy) Case series IV

1998 Dechaud (14)

(France) Case series IV

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Table 19. Articles selected for a critical analysis of salpingoscopy by laparoscopy Year Lead author (Country) Study type Level of evidence 1992 Marconi (15)

(Argentina) Case series IV

1995 Heylen * (23)

(Belgium/South Africa) Case series IV

1995 Marana (16)


1996 Antony (17)

(United Arab Emirates /Belgium/Italy) Case series IV

1996 Surrey (18)


1997 De Bruyne (19)

(Germany) Case series IV

1999 Marana (22)


2001 Marchino (20)


* Data used to describe the complications of salpingoscopy

Table 20. Articles used in the description of salpingoscopy and falloposcopy Year Lead author

(Country) Type of data used

1988 American Fertility Society (21)

(USA) Scores for adhesions or distal occlusive disease

1995 Bruhat (6)

(France) Laparoscopic method

1996 Tran (1)

(France) Tubal anatomy, physiology and disease

1998 Puttemans (7) (Belgium/ South Africa) Method for salpingoscopy,

salpingoscopy score for tubal disease 1999 Surrey (4)

(USA) Method for falloposcopy and salpingoscopy

2001 Dechaud (2)

(France) Diagnostic methods for tubal disease, description of falloposcopy

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ANNEX IV. ARTICLES NOT SELECTED

Table 21. Articles not selected

Year Lead author (Country)

Reason for exclusion from study

1990 Kerin (USA)

Data already published in another article

1994 Scudamore (UK/Canada)

Comparison of salpingoscopic and falloposcopic assessments of the ampullary mucosa – outside remit

1995 Dunphy (Australia/Canada)

Incomplete data

1996 Dechaud (France)

Non-systematic review

1996 Marana (Italy)

Non-systematic review

1997 Sawada (Japan)

Incomplete data

1997 Surrey (USA)

Unusable data

ANNEX V. FALLOPOSCOPY SCORE

Qualities assessed for each of 4 segments of the tube when determining falloposcopy score according to Kerin et al. (9) : 1. Patency 2. Epithelium 3. Vascularity 4. Adhesions 5. Dilatation 6. Other (abnormal intraluminal contents). Each parameter is scored from 1 to 3: 1= normal ; 2=mild to moderate lesion; 3=severe lesion. A total score of 20 or less = normal tubal lumen; 20-30 = mild to moderate endotubal disease and >30 severe endotubal disease.

ANNEX VI. TYPES OF LESIONS RECORDED FALLOPOSCOPICALLY

Types of lesions recorded falloscopically as reported by Kerin et al. (3): - Thin intratubal nonobstructive adhesions - Thick intratubal nonobstructive adhesions - Mucosal atrophy - Polyps - Lumen stenosis - Luminal dilatation - Hydrosalpinx - Fimbrial agglutination.

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ANNEX VII. BROSENS AND PUTTEMANS CLASSIFICATION OF TUBAL LESIONS IDENTIFIED SALPINGOSCOPICALLY

Brosens and Puttemans classification (7)

I Normal mucosal folds II Distended fold pattern III Focal lesions (adhesions, polyps, strictures, aspecific mucosal deposits) IV Extensive lesions

a With preservation of the mucosal folds as such b With partial destruction/disappearance of the mucosa

V Complete loss of the fold pattern.

ANNEX VIII. AFS SCORE (AMERICAN FERTILITY SOCIETY)

VIII.3 Adnexal adhesions (21)

Enclosure

Organ Type 1/3 2/3 3/3

Ovary Filmy 1 2 4 Dense 4 8 16 Tube Filmy 1 2 4 Dense 4 8 16

Scores for the ovary and tube (least affected) are summed to give the following classification: Minimal: 0-5 Mild: 6-10 Moderate: 11-20 Severe: 21-32

VIII.4 Distal tubal occlusion (21)

Distal ampullary diameter <3cm 3-5 cm >5 cm 1 4 6 Tubal wall thickness Normal/thin Moderately thickened Thick and rigid 1 4 6 Mucosal folds at neostomy site Normal/>75 % 35 %–75% <35 % 1 4 6 Extent of adhesions None/minimal/light Moderate Extensive 1 3 6 Type of adhesions None/Filmy Moderately dense Dense 1 2 4

Scores for the ovary and tube (least affected) are summed to give the following classification: Mild: 1-8 Moderate: 9-10 Severe: >10

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REFERENCES

Falloposcopy


Articles selected

1. Tran DK, Leroy JL, Persch M, Bongain A, Daoudi K, NGuyen BMN et al. Stérilité tubopéritonéale. Encycl Méd Chir Gynécologie 1996;750-A-10. 2. Dechaud H, Hedon B. Les endoscopies tubaires. Ref Gynécol Obstet 2001;8(2):138-9. 3. Kerin J, Daykhovsky L, Segalowitz J, Surrey E, Anderson R, Stein A et al. Falloposcopy: a microendoscopic technique for visual exploration of the human fallopian tube from the uterotubal ostium to the fimbria using a transvaginal approach. Fertil Steril 1990;54(3):390-400. 4. Surrey ES. Microendoscopy of the human fallopian tube. J Am Assoc Gynecol Laparosc 1999;6(4):383-9. 5. Scudamore IW, Dunphy BC, Cooke ID. Outpatient falloposcopy: intra-luminal imaging of the fallopian tube by trans-uterine fibre-optic endoscopy as an outpatient procedure. Br J Obstet Gynaecol 1992;99(10):829-35. 6. Bruhat MA, Glowaczower E, Raiga J, Wattiez A, Pouly JL, Canis M et al. Coeliochirurgie. Encycl Méd Chir Gynécologie 1995;71-A-10. 7. Puttemans PJ, de Bruyne F, Heylen SM. A decade of salpingoscopy. Eur J Obstet Gynecol Reprod Biol 1998;81(2):197-206. 8. Lundberg S, Rasmussen C, Berg AÅ, Lindblom B. Falloposcopy in conjunction with laparoscopy: possibilities and limitations. Hum Reprod 1998;13(6):1490-2. 9. Kerin JF, Williams DB, San Roman GA, Pearlstone AC, Grundfest WS, Surrey ES. Falloposcopic classification and treatment of fallopian tube lumen disease. Fertil Steril 1992;57(4):731-41. 10. Pennehouat G, Risquez F, Naouri M, Thebault Y, Guglielmina JN, Deval B et al. Transcervical falloposcopy: preliminary experience. Hum Reprod 1993;8(3):445-9. 11. Rimbach S, Bastert G, Wallwiener D. Technical results of falloposcopy for infertility diagnosis in a large multicentre study. Hum Reprod 2001;16(5):925-30. 12. Bauer O, Diedrich K, Bacich S, Knight C, Lowery G, van der Ven H et al. Transcervical access and intra-luminal imaging of the Fallopian tube in the non-anaesthetized patient; preliminary results using a new technique for Fallopian access. Hum Reprod 1992;7 Suppl 1:7-11.

13. Venezia R, Zangara C, Knight C, Cittadini E. Initial experience of a new linear everting falloscopy system in comparison with hysterosalpingography. Fertil Steril 1993;60(5):771-5. 14. Dechaud H, Daures JP, Hedon B. Prospective evaluation of falloscopy. Hum Reprod 1998;13(7):1815-8. 15. Marconi G, Auge L, Sojo E, Young E, Quintana R. Salpingoscopy: systematic use in diagnostic laparoscopy. Fertil Steril 1992;57(4):742-6. 16. Marana R, Rizzi M, Muzii L, Catalano GF, Caruana P, Mancuso S. Correlation between the American Fertility Society classifications of adnexal adhesions and distal tubal occlusion, salpingoscopy, and reproductive outcome in tubal surgery. Fertil Steril 1995;64(5):924-9. 17. Antony M, Slangen T, van Herendael BJ. Salpingoscopy is an important part of the infertility work-up. J Am Assoc Gynecol Laparosc 1996;3(3):369-74. 18. Surrey ES, Surrey MW. Correlation between salpingoscopic and laparoscopic staging in the assessment of the distal fallopian tube. Fertil Steril 1996;65(2):267-71. 19. de Bruyne F, Hucke J, Willers R. The prognostic value of salpingoscopy. Hum Reprod 1997;12(2):266-71. 20. Marchino GL, Gigante V, Gennarelli G, Mazza O, Mencaglia L. Salpingoscopic and laparoscopic investigations in relation to fertility outcome. J Am Assoc Gynecol Laparosc 2001;8(2):218-21. 21. The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, müllerian anomalies and intrauterine adhesions. Fertil Steril 1988;49(6):944-55. 22. Marana R, Catalano GF, Muzii L, Caruana P, Margutti F, Mancuso S. The prognostic role of salpingoscopy in laparoscopic tubal surgery. Hum Reprod 1999;14(12):2991-5. 23. Heylen SM, Brosens IA, Puttemans PJ. Clinical value and cumulative pregnancy rates following rigid salpingoscopy during laparoscopy for infertility. Hum Reprod 1995;10(11):2913-6.

Falloposcopy


Articles not used

Dechaud H, Hédon B. La falloposcopie en 1996. Contracept Fertil Sex 1996;24(7-8):543-8. Dunphy BC, Greene CA. Falloposcopic cannulation, oviductal appearances and prediction of treatment independent intrauterine pregnancy. Hum Reprod 1995;10(12):3313-6. Kerin J, Surrey E, Daykhovsky L, Grundfest WS. Development and application of a falloposcope for transvaginal endoscopy of the fallopian tube. J Laparoendosc Surg 1990;1(1):47-56. Marana R, Rizzi M. The role of salpingoscopy and falloposcopy in infertility. Curr Opin Obstet Gynecol 1996;8(4):257-60.

Sawada T, Tsukada K, Satoh M, Kawakami S. Correlation between salpingoscopic score and subsequent pregnancy outcome in patients with tubal infertility. J Assist Reprod Genet 1997;14(10):562-5. Scudamore IW, Dunphy BC, Bowman M, Jenkins J, Cooke ID. Comparison of ampullary assessment by falloscopy and salpingoscopy. Hum Reprod 1994;9(8):1516-8. Surrey ES, Adamson GD, Nagel TC, Malo JW, Surrey MW, Jansen R et al. Multicenter feasibility study of a new coaxial falloposcopy system. J Am Assoc Gynecol Laparosc 1997;4(4):473-8.

Falloposcopy


Other references

American Medical Association. Current Procedural Terminology 2000 (CPT 2000). Chicago (IL): AMA; 1999.

Commonwealth Department of Health and Aged Care. Medicare benefits schedule book. Camberra: Commonwealth of Australia; 1999.

Institut National d'Assurance Maladie-Invalidité. Nomenclature des prestations de santé. Bruxelles: INAMI; 2000.

Union des Caisses Nationales de Sécurité Sociale. Nomenclature enrichie à l'usage des praticiens conseils. Paris: UCANSS; 2000.

Union des Caisses Nationales de Sécurité Sociale. Nomenclature générale des actes professionnels des médecins, chirurgiens-dentistes, sages-femmes et auxiliaires médicaux. Nomenclature des actes de biologie médicale. Paris: UCANSS; 2000.