AAGL · Simone Ferrero, MD, PhD ... Moderators: David Eisenstein, M. Jonathon Solnik . Faculty: Sara Y. Brucker, Erica C. Dun, Lena El Hachem, Lenore C. Ellett,

Sponsored by

AAGLAdvancing Minimally Invasive Gynecology Worldwide

Plenary 1 – Laparoscopy

MODERATORS

M.eir Jonathon Solnik, MD & David I. Eisenstein, MD

Sara Y. Brucker, MDLenore C. Ellett, MD

Erica C. Dun, MDSimone Ferrero, MD, PhD

Lena El Hachem, MDRichard S. Guido, MD

Professional Education Information Target Audience This educational activity is developed to meet the needs of residents, fellows and new minimally invasive specialists in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.

Table of Contents

Course Description ........................................................................................................................................ 1 Disclosure ...................................................................................................................................................... 2 Office Visceral Slide Test in Predicting Periumbilical Adhesions: A Pilot Study E.C. Dun ......................................................................................................................................................... 3 Long‐Term Efficacy of Radiofrequency Volumetric Thermal Ablation (RFVTA) of Symptomatic Uterine Fibroids R.S. Guido ...................................................................................................................................................... 6 Intraoperative Blood Loss and Discharge Times after Laparoscopic Global Fibroid Ablation and Laparoscopic Myomectomy: A Blinded Randomized Controlled Trial S.Y. Brucker ................................................................................................................................................... 9 Preoperative Treatment with Aromatase Inhibitor in Patients Undergoing Laparoscopic Myomectomy of Large Uterine Myomas S. Ferrero .................................................................................................................................................... 12 The Effect of Patient Body Mass Index on Surgical Difficulty in Gynaecological Laparoscopy. A Prospective Observational Study L.C. Ellett ..................................................................................................................................................... 15 A Randomized Blinded Trial of Transversus Abdominis Plane (TAP) Block Versus Trocar Site Infiltration for Postoperative Pain Control in Gynecologic Laparoscopy

L. El Hachem ................................................................................................................................... 20 Cultural and Linguistics Competency ......................................................................................................... 24

Plenary 1 – Laparoscopy

Moderators: David Eisenstein, M. Jonathon Solnik Faculty: Sara Y. Brucker, Erica C. Dun, Lena El Hachem, Lenore C. Ellett,

Simone Ferrero, Richard S. Guido, This session provides a range of studies on topics of daily clinical importance to safe and effective laparoscopic practice. It also presents the latest data in the laparoscopic approaches to treatment of fibroids including new technology and preoperative medical therapies. Learning Objectives: At the conclusion of this course, the clinician will be able to: 1) Assess techniques for safe laparoscopic entry; 2) distinguish alternative laparoscopic technologies for treatment of uterine fibroids; and 3) compare approaches to pre-emptive analgesia.

Course Outline 11:00 Office Visceral Slide Test in Predicting Periumbilical Adhesions: A Pilot Study E.C. Dun

11:10 Long-Term Efficacy of Radiofrequency Volumetric Thermal Ablation (RFVTA) of Symptomatic Uterine Fibroids R.S. Guido

11:20 Intraoperative Blood Loss and Discharge Times after Laparoscopic Global Fibroid Ablation and Laparoscopic Myomectomy: A Blinded Randomized Controlled Trial S.Y. Brucker

11:30 Preoperative Treatment with Aromatase Inhibitor in Patients Undergoing Laparoscopic Myomectomy of Large Uterine Myomas S. Ferrero

11:40 The Effect of Patient Body Mass Index on Surgical Difficulty in Gynaecological Laparoscopy. A Prospective Observational Study L.C. Ellett

11:50 A Randomized Blinded Trial of Transversus Abdominis Plane (TAP) Block Versus Trocar Site Infiltration for Postoperative Pain Control in Gynecologic Laparoscopy L. El Hachem All Faculty

12:00 Closing Remarks/Adjourn

1

PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop and have no conflict of interest to disclose (in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* Viviane F. Connor Consultant: Conceptus Incorporated Kimberly A. Kho* Frank D. Loffer, Executive Vice President/Medical Director, AAGL* Linda Michels, Executive Director, AAGL* M. Jonathan Solnik* Johnny Yi*

SCIENTIFIC PROGRAM COMMITTEE Ceana H. Nezhat Consultant: Ethicon Endo-Surgery, Lumenis, Karl Storz Other: Medical Advisor: Plasma Surgical Other: Scientific Advisory Board: SurgiQuest Arnold P. Advincula Consultant: Blue Endo, CooperSurgical, Covidien, Intuitive Surgical, SurgiQuest Other: Royalties: CooperSurgical Linda D. Bradley* Victor Gomel* Keith B. Isaacson* Grace M. Janik Grants/Research Support: Hologic Consultant: Karl Storz C.Y. Liu* Javier F. Magrina* Andrew I. Sokol* FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Sara Y. Brucker* Erica C. Dun Consultant: Plasma Surgical Lena El Hachem* Lenore C. Ellett* David I. Eisenstein* Simone Ferrero* Richard S. Guido Training Consultant: Halt Medical Meir Jonathon Solnik* Asterisk (*) denotes no financial relationships to disclose.

Office Visceral Slide Test in Predicting Periumbilical Adhesions: a Pilot Study

Erica C. Dun, MD, MPH

Adi Katz, MD, and Ceana H. Nezhat, MD

Atlanta Center for Special Minimally Invasive Surgery

and Reproductive Medicine

Disclosures

• Consultant: Plasma Surgical

Objective

• To compare the Office Visceral Slide Test with

two other preoperative tests to detect

obliterating periumbilical adhesions within

the abdomen.

Trocar insertion accounts for 40% of laparoscopic complications &

most of the fatalities

Fuller, J et al. Trocar associated injuries and fatalities: Analysis of 1399 Reports to FDA. J Minim Invas Gyn 2005;12:302‐307.

Entry Complications

• Abdominal wall

• Vascular

• Gastrointestinal

Preoperative Tests for Predicting Adhesions

• Office Visceral Slide Test

• Preoperative Examination with Visceral Slide

• Periumbilical Ultrasound‐Guided Saline

Infusion (PUGSI)

3

Study Design

• Design: Comparison of an office ultrasound diagnostic technique with an

operating room ultrasound diagnostic test and PUGSI test with the gold

standard – laparoscopy

• Patients: 82 women (12 Control, 70 Study) undergoing benign

gynecologic surgery; Study Group included women with previous

abdominal/pelvic surgery

• Interventions: Three screening tests: 1) Office Visceral Slide Test, 2)

Preoperative Examination with Visceral Slide Test, and 3) PUGSI Test

• Measurements: The presence of obliterating umbilical lesions in the high‐

risk patients and the ability of the Office Visceral Slide Test to detect them

Office Visceral Slide Test

Visceral Slide Test

PUGSI Test

4

PUGSI Test Patients with prior surgery, n=70

Sensitivity(95% CI)

Specificity(95% CI)

PPV(95% CI)

NPV(95% CI)

Accuracy(95% CI)

OfficeVisceralSlide Test

83.3%(43.6, 96.9)

100%(94.3, 100)

100%(56.6, 100)

98.5%(91.8, 99.7)

98.6%(92.3, 99.8)

OR VisceralSide Test

83.3%(43.6, 96.9)

96.8%(89.3, 99.1)

71.4%(35.9, 91.8)

98.4%(91.5, 99.7)

95.7%(88.1, 98.5)

PUGSI Test 66.7%(30.0, 90.3)

98.4%(91.7, 99.7)

80.0%(37.5, 96.4)

96.9%(89.5, 99.2)

95.7%(88.1, 98.5)

Extended McNemar Test: χ2 =2, df =1, significance < 0.05, 0.20 < p <0.10Conclusion: no significant difference in the sensitivity and specificity among the 3 Tests

Conclusion

• Office Visceral Slide Test (OVST) is a simple and reliable

test for detecting obliterating periumbilical adhesions.

• OVST is comparable to other validated tests.

• OVST may have value for preoperative surgical

assessment and planning laparoscopic abdominal entry.

• Implementing the OVST may decrease injuries, allow

surgeons to be better prepared for complications, and

increase the number of patients benefiting from minimally

surgery.

References

• Brill AI, Nezhat F, Nezhat CH, Nezhat C. The incidence of adhesions after prior

laparotomy: a laparoscopic appraisal. Obstetrics and gynecology. Feb

1995;85(2):269‐272.

• Kodama I, Loiacono LA, Sigel B, et al. Ultrasonic detection of viscera slide as an

indicator of abdominal wall adhesions. Journal of clinical ultrasound : JCU. Jul‐Aug

1992;20(6):375‐380.

• Nezhat C, Cho J, MorozovV, Yeung P, Jr. Preoperative periumbilical ultrasound‐

guided saline infusion (PUGSI) as a tool in predicting obliterating subumbilical

adhesions in laparoscopy. Fertility and sterility. Jun 2009;91(6):2714‐2719.

• Tu FF, LamvuGM, Hartmann KE, Steege JF. Preoperative ultrasound to predict

infraumbilical adhesions: a study of diagnostic accuracy. American journal of

obstetrics and gynecology. Jan 2005;192(1):74‐79.

5

Long-term Efficacy of Radiofrequency Volumetric Thermal Ablation (RFVTA) of Symptomatic Fibroids

Richard S. Guido, MD University of Pittsburgh Medical Center, Pittsburgh, PA

Disclosures

• Consultant: OmniGuide

Objective

• At the end of this lecture, the clinician will be able

to describe the clinical significance of

radiofrequency volumetric thermal ablation

(RFVTA) at two years’ follow up in terms of

• Subject responses to validated questionnaires

• Uterine Fibroid Symptom and Quality of Life (UFS-QOL)1

• Mean Health State Scores (EQ-5D)2

• Adverse events

• Surgical re-intervention for fibroid-related bleeding

Design and Setting

• Prospective follow up of patients through 24 months

posttreatment in a multicenter, international trial of

outpatient, laparoscopic ultrasound-guided RFVTA of

symptomatic uterine fibroids3,4

• Continuous and categorical variables summarized

based on t-test, paired t-test, signed-rank test, and

chi-square test

• p-values < 0.05 were significant

• 11 University hospitals and private surgery centers

Flow of Subjects Through StudyEnrolledN = 137

Baseline assessed and

treatedN = 137

Analysis setN = 135

Outside protocol inclusion/alkaline hematin parametersN = 2

No bleeding assessment at 12 monthsN = 11

(3 pregnancies, 4 with no 12-month menses,1 with Hashimoto’s Disease,

3 lost to follow up or withdrew)

2-Year follow-up questionnaires possibleN = 113

24-Month questionnaires receivedN = 112

Analysis set entering year 2

N = 124

No assessment at 24 monthsN = 11

(6 reinterventions, 1 Novasure ablation w/o fibroids,3 lost to follow up or withdrew,

1 pregnancy)

Study Participants Entering Year 2

• 124 Premenopausal women

• Mean age: 42.4 ± 4.4 years

• Mean BMI: 30.5 ± 6.2

• Having symptomatic uterine fibroids (as measured by

transvaginal ultrasound [TVUS] and magnetic

resonance imaging [MRI])

• Objectively confirmed (alkaline hematin testing) heavy

menstrual bleeding (≥ 160 to ≤ 500 mL) at baseline

6

Intervention: laparoscopic ultrasound-guided RFVTA [ACESSATM]

Results: UFS-QOL Mean Transformed Scores

37.3

75.177.8 79.5 79.3

61.1

29.1 28.526.6 25.4

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

80.0

90.0

100.0

Baseline (n=127) 3 Months (n=124) 6 Months (n=125) 12 Months (n=124) 24 Months (n=112)

Mea

n T

ran

sfo

rmed

UF

S-Q

OL

Sco

res

HRQL Symptom Severity

Results:UFS-QOL Subscale Scores

24.7

37.1 38.1

45.5

38.2

45.5

67.4

76.975.1

80.7

74.7 75.1

69.4

79.3 79

84

77.175.4

71.4

79.9 80.3

86.3

79.8 78.5

70.8

81.179.3

85.8

82.1

74.1

0

10

20

30

40

50

60

70

80

90

100

Concern Activities Energy/Mood Control Self-consciousness Sexual Function

Mea

n T

ran

sfo

rmed

UF

S-Q

OL

Su

bsc

ale

Sco

res

Baseline (n=127) 3 Months (n=124) 6 Months (n =125) 12 Months (n=124) 24 Months (n=112)

Results:Mean Health State Scores (EQ-5D)

71.1

85 84.8 85.884

0

10

20

30

40

50

60

70

80

90

100

Baseline (n=126) 3 Months (n=122) 6 Months (n=124) 12 Months (n=123) 24 Months (n=111)

Mea

n H

ealt

h S

tate

Sco

re

Serious Adverse Event: possibly related to procedure

• Excessive blood loss at full-term delivery

• Subject delivered a healthy, full-term baby by C-section

• During C-section, subject lost 1400–1500 mL blood

• 2 Days later, she experienced abdominal pain, additional blood loss

and tissue expulsion

• Pathology showed degenerative fibroid tissue

• Patient received 6 units of blood

• She was discharged with oral iron therapy for her anemia

Surgical re-interventions for fibroid-related bleeding

• 4 Hysterectomies

• 2 Hysteroscopic myomectomies

• Follow-up pathology was available for 5 of the 6 patients

• Multiple small fibroids and adenomyosis (n = 4)

• Possible polyp (n = 1)

• Re-intervention Rate

• 0 to12 months: 0.8% (1/127)

• 12 to 24 months: 4.8% (6/124)

• 0 to 24 months: 5.7% (7/124)

7

Discussion

• UFS-QOL and EQ-5D scales have been validated1,2,5

• Results from these validated scales show continued

benefits out to 24 months of follow up

• The 3-month outcomes appear to predict long-term

results

• Re-intervention rate at 2-3 years for other uterine-

conserving procedures can be as high as 26%6,7

• Important to follow patients beyond 12 months to

confirm durability of treatment

Conclusions:RFVTA results indicate

• Procedure is safe and efficacious

• Durable and significantly improved quality of life

and decreased symptom severity out to 2 years

• Low re-intervention rate

• Results are positive outcomes for patients’

wellbeing through 2 years of follow up

References1. Spies JB, Coyne K, Guaou Guaou N, et al. The UFS-QOL, a new disease-specific symptom and

health-related quality of life questionnaire for leiomyomata. Obstet Gynecol 2002;99(2):290–300.

2. Johnson Ja, Luo N, Shaw JW, et al. Valuations of EQ-5D health states: are the United States and

United Kingdom different? Medical Care 2005;43(3):221–228.

3. Chudnoff SG, Berman JM, Levine DJ, et al. Outpatient procedure for the treatment and relief of

symptomatic myomas. Obstet Gynecol 2013;121(5):1075–1082.

4. Guido RS, Macer JA, Abbott K, et al. Radiofrequency volumetric thermal ablation of fibroids: a

prospective, clinical analysis of two years’ outcome from the Halt trial. HQLO 2013;11:1–8.

5. Coyne KS, Margolis MK, Bradley LD, et al. Further validation of the uterine fibroid symptom and

quality-of-life questionnaire. Value Health 15(1):135–142.

6. Mara M, Maskova J, Fucikova Z, et al. Midterm clinical and first reproductive results of a

randomized led trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent

Radiol 2008;31(1):73–85.

7. Bongers MY, Mol BW, Dijkhuizen FP, Brölmann HA. Is balloon ablation as effective as endometrial

electroresection in the treatment of menorrhagia? J Laparendosc Adv Surg Tech A 2000;10(2):85–92.

8

Intraoperative Blood Loss and Discharge Times after Laparoscopic Global Fibroid Ablation and Laparoscopic Myomectomy: a Blinded Randomized Controlled Trial

Sara Y. Brucker, MD University of Tübingen, Tübingen, Germany

Disclosures

• I have no financial relationships to disclose.

Objectives

• At the end of this lecture, the clinician will be able

assess mean hospital discharge times and

perioperative outcomes for laparoscopic global

fibroid ablation (radiofrequency volumetric

thermal ablation of fibroids [RFVTA—Acessa™])

and laparoscopic myomectomy (LM)

Study DesignSingle site and randomized: compares two minimally invasive, uterine-sparing treatments for symptomatic uterine fibroids

• Laparoscopic Ultrasound-Guided RFVTA using Acessa™

• Laparoscopic Myomectomy

Primary endpoint• Hospitalization time—number of hours from induction of anesthesia

to discharge from the hospital

Secondary endpoints• Intraoperative blood loss

• Postprocedure use of pain medication

• Days to return to normal activities of daily living

Major Inclusion/Exclusion Criteria

• Women ≥ 18 years old, menstruating, desiring

uterine conservation, and w/normal pap

• Symptomatic fibroids of <10 cm, uterus <16 wks

• No contraindications for laparoscopic surgery

• No significant intra-abdominal adhesions

• No major concomitant procedures

• No implanted intrauterine or fallopian device

• No suspected endometriosis or adenomyosis

• R/O intracavitary submucous fibroids that are better treated by hysteroscopic resection

Operative Procedures and Randomization

• Hysteroscopy performed on all subjects• Rule out Type 0 or 1 intracavitary fibroids

• Following laparoscope insertion• Subject assessed for continued suitability for either procedure; if

not suitable for both, subject excluded

• Ultrasound mapping using a laparoscopic ultrasound probe • Located and measured fibroids

• Recorded time of mapping

• Randomization – Call made to central location and envelope opened• 1:1 randomization

9

Laparoscopic Ultrasound Mapping and RFVTA Discharge Assessment

• Protocol for assessment at 4 hours post treatment• No concerns regarding post op bleeding?• No adhesiolysis performed at surgery?• Is the patient awake enough to function?• Is patient able to ambulate without assistance?• Is the patient able to use the bathroom and urinate?• Is the pain level tolerable?• Is the patient able to take oral pain meds?• No intraoperative or post op complications?

• If “Yes” to all of the above, patient is discharged.

Results: Demographics

50 enrolled and treated subjects met all criteria (25

RFVTA and 25 LM)

• RFVTA patients were about 5.6 years older than the LM

patients (40.0 years vs 34.4 years)

• Height and weight were similar between groups

• In both groups, heavy menstrual bleeding was the

primary complaint (84% RFVTA, 72% LM)

• Next most common complaints

• urinary frequency (52% RFVTA, 36% LM) and

• pelvic pain and discomfort (40% RFVTA, 44% LM)

Results: Types of Treated and Excised Fibroids

Variable RFVTALaparoscopic Myomectomy

Fibroid type

Submucosal 0 (0%) 0 (0%)

Transmural 0 (0%) 1 (2.0%)

Intramural 33 (46.5%) 18 (36.7%)

Intramural abutting the endometrium

2 (2.8%) 1 (2.0%)

Subserosal 36 (50.7%) 33 (67.3%)

Pedunculated subserosal 0 (0%) 2 (4.1%)

Total fibroids treated/excised 71 49

Fibroids treated/excised as a percentage of those imaged on LUS

98.6% (71/72) 80.3% (49/61)

Results - Primary Endpoint

• Mean total hospitalization time (start of

anesthesia to discharge readiness) significantly

shorter for RFVTA subjects (p < .0001)

• RFVTA 9 h 59 min (range 4 h 12min–25 h 30 min)

• LM 29 h 56 min (range 16h 6 min–68 h 6 min)

Reasons for Overnight Hospitalization

• LM (25)– Standard of Care in Germany• Concern for bleeding from uterine incisions

• Inability to ambulate without help or dizziness

• Unable to urinate

• Pain requiring narcotics

• Lack of alertness

• RFVTA (5)• 1 patient elected to stay

• 1 w/fatigue and vomiting

• 2 w/dizziness

• 1 with pain following adhesiolysis

12

10

Results - Secondary Endpoints• Mean blood loss

• RFVTA 16.2 mL

• LM 50.6 mL

• Pain medication use in first week similar

• 20% RFVTA subjects took no pain meds

• 17.6% LM subjects took no pain meds

• No significant difference in return to normal

activities between groups

Perioperative Safety Results

Three perioperative complications were related to the procedure

• One RFVTA subject had vertigo due to anesthesia

• One LM subject had a hematoma at the trocar site

• One RFVTA subject had hypermenorrhea upon her first menses

Two serious adverse events not related to procedure or device

• RFVTA subject returned to hospital 17 days post op with a ruptured

ovarian cyst

• LM subject became pregnant early in her post treatment period;

scan showed anecephaly and pregnancy was terminated

14

Conclusions

• RFVTA with Acessa resulted in

• Greater percentage of treated fibroids than at LM

• Significantly shorter hospitalization time than with LM

• Less intraoperative blood loss than at LM

• Similar use of pain medication as LM subjects

• Similar time to return to normal activities as LM subjects

• No myometrial incisions

11

PREOPERATIVE TREATMENT WITH AROMATASE INHIBITOR IN

PATIENTS UNDERGOING LAPAROSCOPIC MYOMECTOMY OF LARGE UTERINE MYOMAS

S. Ferrero, PhD

Department of Obstetrics and Gynaecology, San Martino Hospital and National

Institute for Cancer Research, University of GenoaUniversity of Genoa, Italy

Preoperative treatment with aromatase inhibitor in patients undergoing laparoscopic myomectomy of large uterine myomas

Disclosure

I have no financial relationships to disclose.

University of Genoa, Italy


Objective of the study

After this lecture, the attendee should implementthe preoperative hormonal treatment prior tolaparoscopic excision of large uterine myomas

To assess the efficacy of preoperative treatmentwith AIs in premenopausal women undergoinglaparoscopic myomectomy of large uterinemyomas



Background• The use of gonadotropin-releasing hormone analogues (GnRHa) in the 3-4

months before surgery is a consolidated strategy to decrease both uterinevolume and fibroid size (Lethaby et al., 2001)

• In addition, the preoperative treatment with GnRHa has been demonstratedbeneficial in the correction of pre-operative iron deficiency anaemia, if present,and reduce intra-operative blood loss (Lethaby et al., 2001; Chen et al., 2011)

• Similarly, aromatase inhibitors (AIs) block estrogen synthesis and have beenused as medical management of uterine myomas (Shozu et al., 2003; Varelas etal., 2007; Gurates et al., 2008; Hilário et al., 2009; Parsanezhad et al., 2010)

• Continuous administration of AIs to premenopausal women may cause thedevelopment of functional ovarian cysts; therefore, hormonal therapiessuppressing ovarian activity is required (Remorgida et al., 2007; Ferrero et al.,2010)



Inclusion Criteria Exclusion Criteria

Reproductive age Previous uterine surgery

One intramural myoma with larger diameter ≥ 8 cmUse of hormonal therapies in the 6 months prior to inclusion in the study

Number of myomas ≤ 3 Previous use of AIs

Largest diameters of the other myomas respectively ≤ 5 cm (second myoma) and ≤ 3 cm (third myoma)

Additional diseases requiring surgical treatment (such as endometriosis, tubal surgery, appendicitis)

Unwillingness to tolerate menstrual changes

Undiagnosed vaginal bleeding

Pregnancy or immediate desire to conceive

Osteopenia or osteoporosis

Current or past history of seizure disorders

Pulmonary, cardiac, hepatic or renal diseases

Thromboembolic or cerebrovascular events

Materials and methods



Prospective open-label pilot study

Group A (n=26)

Treatment with oral letrozole* (2.5 mg/day) and norethindroneacetate (2.5 mg/day) plus elemental calcium (1000 mg/day) and vitamin D3 (880 IU/day) continuously in the three months prior to surgery

*Letrozole is not approved for the treatment of uterine myomas by the FDA and Italian Ministry of Health and, therefore, the use of these drugs should be considered experimental

Group B (n=26)

No treatment

12



Ultrasonographic evaluation of myomas

• Location of the myomas

• Number of the myomas

• Largest diameter of the myomas

• Volume of the myomas: VOCAL (GE Healthcare, USA) at baseline and at surgery (after 3 months of treatment)

Hematochemical exams

• Hemoglobin concentration: on the day before surgery and 24 hours after surgery

Characteristics of surgery

• Methods of anesthesia

• Surgical technique

• Total operative time

• Time required to suture the hysterotomies

• Estimated blood loss

• Degree of surgical difficulty encountered in the cleavage of the myomas (5-point Likert scale)

Postsurgical evaluation

• Quality of suture (3-point Likert scale) at 1 week and 3-month from surgery



ResultsCharacteristics of the study population

Group A Group B p

Age (mean ± SD, years) 35.1 ± 3.9 34.6 ± 3.6 0.512

BMI (mean ± SD) 23.3 ± 1.7 22.9 ± 1.8 0.389

Patients with previous live births (n, %)

14 (53.8%) 14 (53.8%)1

Parity (median, range) 2 (1-3) 2 (1-4) 0.839

Level of education (n, %):Primary

SecondaryHigher

0 (0%)14 (53.8%)12 (46.2%)

0 (0%)16 (61.5%)10 (38.5%) 0.779

Ethnicity (n, %)Caucasian

AfricanIspanic

24 (92.4%)1 (3.8%)1 (3.8%)

23 (88.5%)0 (0%)

3 (11.5%)0.364

Indication for myomectomy (n, %)Abnormal uterine bleeding

InfertilityAbortion

Pain/Pelvic pressure

12 (46.2%)9 (34.6%)2 (7.7%)3 (11.5%)

10 (38.5%)12 (46.2%)

1 (3.8%)3 (11.5%)

0.815



Characteristics of the myomas

Group A Group B p

Number of myomas (median, range) 1 (1-3) 1 (1-3) 0.622

Total number of myomas (n) 38 35

Proportion of patients according to number of myomasOneTwo

Three

16 (0%)8 (53.8%)2 (46.2%)

19 (0%)5 (61.5%)2 (38.5%)

0.622

Localization of myomas (n/total, %)AnteriorPosterior

LateralFundal

Infralegamentary

14/38 (36.8%)10/38 (26.3%)5/38 (13.2%)8/38 (21.1%)1/38 (2.6%)

12/35 (34.3%)13/35 (37.1%)

3/35 (8.6%)7/35 (20.0%)

0/35 (0%)

0.737

Main diameter of the largest myoma at baseline (cm; mean ± SD) 9.5 ± 1.7 9.1 ± 1.5 0.234

Volume of the largest myoma at baseline (cm3; mean ± SD) 320 ± 157.8 290.3 ± 149.7 0.379



Percentage change in the total myoma volume of each patient at surgery

Group ABaseline At surgery Decrease (mean, 95% CI) p

Main diameter of the largest myoma at baseline (cm; mean ± SD) 9.5±1.7 8.1±1.5 -15.2±0.9, 1.4-29.0% <0.001

Volume of the largest myoma at baseline (cm3; mean ± SD) 320.9±157.8 191.6±95.2 -40.6±3.8%, 21.7-59.5% <0.001

Total myoma volume* at baseline (cm3; mean ± SD) 329.5±161.7 196.8±97.8 -40.6±3.7%, 21.7-59.5% <0.001

*Total myoma volume was defined as the addition of the volume of the myomas affecting each uterus

‐60

‐50

‐40

‐30

‐20

‐10

0

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

%

Patients



Characteristics of surgery

Group A Group B p

Total operative time (mean ± SD, range, minutes) 130.8 ± 20.8; 98–181 139.4 ± 18.5; 115–185 0.076

Time required to suture the hysterotomies (mean ± SD, range, minutes) 26.9 ± 5.4; 16–39 36.8 ± 10.1; 17–57 < 0.001

Mean preoperative hemoglobin concentration (mean ± SD, range, g/dl) 11.1 ± 0.6; 10.1–12.1 11.4 ± 0.8; 9.8–12.5 0.194

Decrease in hemoglobin concentration (mean ± SD, range, g/dl) 0.7 ± 0.3; 0.3–1.4 1.2 ± 0.5; 0.5–2.4 < 0.001

Intraoperative blood loss (mean ± SD, range, ml) 332.5 ± 149.4; 95-625 519.2 ± 214.9; 255-1115 0.002

Blood transfusions (n, %) 0 (0%) 0 (0%) 1

Major complications (n, %)Ureteric injuryBladder injury

Bowel injury

0 (0%)0 (0%)0 (0%)

0 (0%)0 (0%)0 (0%) 1

Degree of difficulty in the cleavage of myomas (n, %)Very easy

EasyNeutral

DifficultVery difficult

1 (3.9%)7 (26.9%)10 (38.5%)5 (19.2%)3 (11.5%)

3 (11.5%)17 (65.4%)3 (11.5%)2 (7.7%)1 (3.9%)

0.024



Ultrasonographic evaluation of the quality of the suture

Group A Group B p

1 week from surgeryGood

NeutralBad

2240

1691

0.144

3 months from surgeryGood

NeutralBad

2510

2330

0.610

13



Discussion• This pilot study demonstrates that the preoperative

administration of letrozole for 3 months decreases the timerequired to suture the hysterotomies and the intraoperativeblood loss without decreasing the quality of the suture ofthe uterine wall detect.

• The major limitation of this study is that it was notrandomized

• Future randomized studies should compare the usefulnessof preoperative administration of AIs and gonadotropin-releasing hormone analogues prior to laparoscopicmyomectomy.



• Chen I, Motan T, Kiddoo D. Gonadotropin-releasing hormone agonist in laparoscopic myomectomy:systematic review and meta-analysis of randomized controlled trials. J Minim Invasive Gynecol2011;18:303-9.

• Ferrero S, Venturini PL, Remorgida V. Letrozole monotherapy in the treatment of uterine myomas. FertilSteril 2010;93:e31.

• Gurates B, Parmaksiz C, Kilic G, et al. Treatment of symptomatic uterine leiomyoma with letrozole.Reprod Biomed Online 2008;17:569-74.

• Hilário SG, Bozzini N, Borsari R, Baracat EC. Action of aromatase inhibitor for treatment of uterineleiomyoma in perimenopausal patients. Fertil Steril 2009;91:240-3.

• Lethaby A, Vollenhoven B, Sowter M. Pre-operative GnRH analogue therapy before hysterectomy ormyomectomy for uterine fibroids. Cochrane Database Syst Rev 2001;(2):CD000547.

• Parsanezhad ME, Azmoon M, Alborzi S, et al. A randomized, controlled clinical trial comparing the effectsof aromatase inhibitor (letrozole) and gonadotropin-releasing hormone agonist (triptorelin) on uterineleiomyoma volume and hormonal status. Fertil Steril 2010;93:192-8.

• Remorgida V, Abbamonte LH, Ragni N, Fulcheri E, Ferrero S. Letrozole and desogestrel-only contraceptivepill for the treatment of stage IV endometriosis. Aust N Z J Obstet Gynaecol 2007;47:222-5.

• Shozu M, Murakami K, Segawa T, Kasai T, Inoue M. Successful treatment of a symptomatic uterineleiomyoma in a perimenopausal woman with a nonsteroidal aromatase inhibitor. Fertil Steril 2003;79:628–31.

• Varelas FK, Papanicolaou AN, Vavatsi-Christaki N, Makedos GA, Vlassis GD. The effect of anastrazole onsymptomatic uterine leiomyomata. Obstet Gynecol 2007;110:643-9.

References

14

The effect of patient body mass index on surgical difficulty in gynaecological laparoscopy

Dr Lenore Ellett FRANZCOG, Mercy Hospital for Women, Melbourne, Australia

Declaration


Objectives

At the conclusion of this activity participants will be able to list complication rates of laparoscopic surgery at different BMI categories.

Background

Obesity has been well studied in obstetrics and we are well aware of problems to mother and baby including Gestational hypertension/pre eclampsia

Gestational Diabetes

Congenital abnormalities

Increased risk of still birth

Increased caesarean section rate

(Jarvie 2010, Rowlands 2010)

Obesity and laparoscopic surgery

Not as well studied

Available literature recommends laparoscopic approach superior to open in the obese due to Reduction post operative stay

Reduced wound infection

Reduced post operative fever and ileus Lamvu (2004)

15

Obesity and Laparoscopic surgery

Can the planned surgery be completed in overweight and obese women undergoing gynaecological laparoscopy for benign pathology?

Do obese women face an increased risk of complications with a laparoscopic approach?

Is the conversion to laparotomy rate increased in the obese population?

Methods - Recruitment

Ethical Approval was obtained from the Human Research Ethics Committee Mercy Hospital for Women

Recruitment commenced Jan 2009 and ran until Oct 2012

Inclusion Criteria Woman aged over 18 attending Mercy Hospital for Women English speaking Booked for laparoscopy

Study Design

Baseline data was collected including: Age

Previous surgery

Reason for operation, intended operation

Weight (kg)

Height (m)

Waist circumference (cm)

Hip circumference (cm)

Study Design

Intraoperative data was recorded on a standard data entry sheet and contained the following information Operation indication Complexity of procedure

Entry technique used and number of attempts Anatomical landmarks

Inferior epigastric artery right and left Ureters right and left Surgery performed Was surgery completed as planned and why?

Other data recorded

Who was the operator (consultant/fellow/registrar) Conversion to laparotomy and reason Difficulty of surgery

Simple operative eg ovarian cystectomy Complex operative eg excision gr III endo Advanced procedure eg TLH

Degree of pelvic adhesions 6 week check:

Length of stay in hospital Any complications

L Inferior epigastric – “2”

Obliterated umbilical artery

Insertion round lig

Inferior epigastric

16

R Inferior epigastric – “1”

Obliterated umbilical artery

Insertion round lig Inferior epigastric

L Inferior epigastric – “0”

Insertion round lig

Obliterated umbilical

epigastric ?? Not seen

Other data recorded

6 week check: Length of stay in hospital Any complications

Clavien-Dindo classification of surgical complications

GRADE Description

I Any deviation from normal postoperative course without the need for pharmacological, surgical, endoscopic, radiological interventions(Allowed therapeutic regimens are antiemetics, antipyretics, analgaesics, diuretics, electrolytes, physiotherapy)

II Requiring pharmacological treatment with drugs other than such allowed for grade I. blood transfusions and TPN are included

III Requiring surgical, endoscopic or radiological interventiona. Not under general anaesthetic b. under general anaesthetic

IV Life threatening complication (including CNS complications) requiring ICU managementa. Single organ b. multi organ

V death

Power calculation and Statistics

A pilot study of 60 patients was completed in 2009 and based on this it was estimated 299 patients would be needed to have sufficient power to show a difference in the ability to complete an operation based on BMI

All data was analysed using the program SPSS 14

Participant flow diagram318 women about to undergo laparoscopy

Approached to be part of BMI trial

310 women participated in trial

Data analysed

307 available for statistical analysis

143 women BMI ≥18 - 24.9 kg/m2 healthy

91 women BMI ≥25 –29.9kg/m2 overweight

45 women BMI 30 –34.9 kg/m2 obese

28 women BMI >35 morbidly obese

3 women incomplete data

8 women declined entry

17

Baseline Demographics *p<0.05

BMI <25 25 – 29.9 ≥30 (>35) OverallAge (mean) * 32.26 36.24 36.33 36.32 34.41

Waist:Hip(mean)*

0.79 * 0.81 * 0.85 * 0.88 0.81

Prior SurgeryNil *LaparoscopyLaparotomy *Other

36.36%43.36%18.88%

1.40%

40.66%29.67%29.67%

31.51%38.36%30.14%

28.57%28.57%

*42.86%

36.48%38.11%24.76%

0.65%ProcedureDiagnosticSimple OpComplex OpAdvanced Op

18.88%47.55%21.68%11.89%

15.38%48.35%23.08%13.19%

12.33%50.68%16.44%20.55%

14.29%42.86%21.43%21.43%

16.29%48.53%20.85%14.33%

Adhesions *Nil *Mild *Mod *Severe *

47.55%26.57%20.98%

4.90%

39.56%32.97%13.19%14.29%

41.10%23.29%17.81%17.81%

32.14%21.43%28.57%17.86%

43.65%27.69%17.92%10.75%

RESULTSBMI <25 25-29.9 30-34.9 ≥ 35 Overall Sig?

Complication rate

7.69% 8.9% 4.5% 10.3% 7.86% p=0.7

Entry attempts >1

10.48% 13.48%p=0.538

13.63%p=0.351

17.24%p=0.337

12.45% p=0.5

Veress needleEndopath XCEL®

Hasson

48.25%50.35%1.40%

51.65%47.25%1.1%

39.73%60.27%0%

39.29%60.71%0%

47.1%51.3%1.3%

p=0.006

Conversion to laparotomy

2/1431.39%

5/915.49%

1/731.37%

0/280%

8/3072.6%

p=0.29

% surgery completed as planned

93.7% 93.25% 97.26% 93.10% 94.4% p=0.2

Complications

Overall complications 7.86% (laparotomy excluded)

Minor complications 6.8% Clavien-Dindo I/II

Major complications 0.098% Clavien Dindo III/IV

Vesicovaginal fistula post TLH

Ureteric burn TLH

Asystole requiring CPR at insufflation (surgery cancelled)

Complications and mean BMI

Mean BMINO complication

Mean BMI With complication

P-value

Complication including laparatomy(overall 10%)

26.3 26.8 0.07 (t student test)

Complication not including laparotomy

26.3 26.9 0.6(t student test)

Laparotomy alone (overall 2.6%)

No conversion26.4

Conversion26.1

0.8(t student test)

Results – Surgical landmarks

BMI <25 25 – 29.9 ≥30 (>35) Significant

R epigastric artery% not visible

0 8.9% 20.4% 27.5% Yesp=0.001

L epigastric artery % not visible

0 7.8% 13.6% 34.4% Yes p=0.001

R ureter % not visible 6.2% 12.35% 9% 31% Yesp=0.06

L ureter % not visible 6.2% 14.6% 15.9% 41.3% Yesp=0.001

18

Discussion

The strengths of this study were that it was a prospective trial that quantified the risks of surgery and looked at the role BMI played

Our findings are in keeping with the literature on laparoscopic hysterectomy for endometrial cancer (O’Hanlan 2003, Obermair 2005)

Laparoscopy is safe in overweight women – the group most likely to benefit from a laparoscopic approach

Equipment is very important - we found the use of pedi ports to be essential

Conclusion

Laparoscopic surgery can be offered to patients who are obese and overweight

Be aware that anatomical landmarks may be obscured

Majority of patients will be able to have surgery completed laparoscopically and in this trial conversion to laparotomy rates did not increase as BMI increased

Complication rates did not significantly increase as BMI increased (max BMI in this study 49.7)

It is anticipated that at the current rate of increase of overweight Australians, by 2020, 75% of the population will be overweight or obese and 65% of young Australians will be overweight or obese.

ReferencesJarvie E, Ramsay JE (2010) Obstetric management of obesity in

pregnancy. Semin Fetal Neonatal Med 15:83–88Rowlands I, Graves N, de Jersey S et al (2010) Obesity in

pregnancy: outcomes and economics. Semin Fetal Neonatal Med 15:94–99

Lamvu G, Zolnoun D, Boggess J et al (2004) Obesity: physiologic changes and challenges during laparoscopy. AJOG 191(2):669–674

O’Hanlan KA, Lopez L, Dibble S et al (2003) Total laparoscopichysterectomy: body mass index and outcomes. Obstet Gynecol

102(6):1384–1392Obermair A, Manolitsas TP, Laung Y et al (2005) Total

laparoscopic hysterectomy versus total abdominal hysterectomy for obese women with endometrial cancer. Int J Gynecol Cancer15:319–324

19

Lena El Hachem, MD Fellow

Division of Minimally Invasive Surgery

Mount Sinai Medical Center, New York, NY


Known advantages of laparoscopy : better cosmetic results, decreased blood loss, decreased postoperative pain, shorter hospital stay, faster recovery time.

Laparoscopic procedures are reported to cause intense pain during the immediate postoperative period (24h).

Multifactorial pain: Somatosensory

Visceral

Referred shoulder pain

Decreased postoperative pain has been associated with improved outcome and patient satisfaction, a reduction in opioid consumption and fewer side effects.

Wu et al., Region Anesth Pain Med, 2005

Traditional approaches include:Perioperative narcotics and NSAIDS (IV or PO)

Local infiltration of anesthetics at trocar sites 2

Intraperitoneal instillation of anesthetics 3

Tap block was shown to be efficacious in reducing postoperative pain after abdominal surgery as demonstrated in a meta‐analysis of 18 RCT.

Siddiqui et al., J Clin Anesth, 2011

Conflicting data regarding gynecologic laparoscopy:RCT of Tap block using 0.5% ropivacaine versus saline in laparoscopic hysterectomy (66 patients) showed significant decrease in pain.

De Oliveira et al., Obstet & Gynecol, 2011

RCT of Tap block using 0.5% ropivacaine versus saline in TLH (58 patients) showed no significant decrease in pain scores or narcotic use.

Kane et al. , AJOG, 2012

Peripheral nerve blockade of the nerves supplying the anterior abdominal wall

‐ Intercostal nerves (T7‐T11)

‐ Subcostal nerve (T12)

‐ Ilioinguinal and iliohypogastric nerves (L1‐L2)

Local anesthetic is deposited through a single entry point between the internal oblique and transversus abdominis muscles 7

Provides unilateral analgesia between the costal margin and the inguinal ligament

Local anesthetics increasingly used as alternative to opiates. However, little consensus regarding:

Timing

Dosing

Anatomic location of the injection

Studies have yielded varying results ranging from considerable pain reduction to no pain reduction.

Limitations: subjectivity of pain assessment and multiple factors interfering with perception of pain

Optimal perioperative pain management remains controversialNo standard of care exists and management is based on surgeon and anesthesiologist preferences

20

Null Hypothesis: TAP block does not reduce postoperative pain compared to traditional trocar site infiltration of bupivacaine in gynecologic laparoscopy

Objective: To prospectively compare postoperative pain in patients receiving unilateral TAP block and contralateral local infiltration analgesia

Subjective measures: Postoperative pain scores on Tap side versus contralateral side

Spontaneously and on palpation

Objective measures: Postoperative narcotic use converted to morphine sulfate equivalents

Complications

Prospective randomized blinded clinical trial using the patients as their own controls.

Treatment side randomized to right or left side of abdomen

Patients and postoperative assessors blinded to the laterality of treatment

Set at White Plains Hospital. IRB approved in January 2013, ongoing study

Single surgeon, two anesthesiologists

Criteria of inclusion:Patients aged >18 undergoing gynecologic laparoscopy using 4‐port symmetrical technique.

Criteria of exclusion: Known allergy to anesthetic

Refusal to participate in the study or follow‐up assessment

Any conversion to laparotomy , more or less than 4 ports

Power analysisPrimary outcome: patient‐reported pain score

A 2 point difference in pain scores was considered clinically significant

A sample size of 34 patients in each cohort is able to detect a difference of 2.0 points in pain score with a power of 80%, assuming a SD of 4 and a 2‐sided alpha of 0.05

Standardized regimen for all patients :

‐Intraoperative IV Acetaminophen and Ketorolac

‐ Postoperative analgesics upon request

Cohort 2

Anesthesiologist‐ administered ultrasound‐guided Tap block versus trocar infiltration

‐ Tap side via ultrasound :30 mLof .25% bupivacaine with epinephrine

‐ Contralateral side: 30mL of .25% bupivacaine with epinephrine in divided doses in the port sites

Cohort 1

Surgeon‐ administered laparoscopic‐guided Tap block

versus Trocar infiltration

‐ Tap side via laparoscopy: 30 mLof .25% bupivacaine with epinephrine

‐ Contralateral side: 30 mL of .25% bupivacaine with epinephrine in divided doses in the port sites

Figure 1: Study Design

Experimental Arm

Total of 30 mL of .25% Bupivacaine with epinephrine (max 2.5 mg/kg)

Mid‐axillary line between the costal margin and the iliac crest

Control Arm

Total of 30 mL of .25% Bupivacaine with epinephrine (max 2.5 mg/kg)

Contralateral side lateral port 40% (3,3,3,3=12)

Midline umbilical on contralateral side only 40% (6,6=12)

Supra pubic sites on contralateral side only, 20% (3,3=6)

Demographic and surgical data: age, race, BMI, ASA, diagnosis, procedure, surgical time, estimated blood loss

Postoperative pain was assessed using the Numeric Rating Scale (NRS) [0‐10] on the Tap side and contralateral side

At 1,2,4,6,8,12,18,24,48 hours postoperatively

Spontaneously and on palpation of the incisions

Postoperative analgesic use (IV and PO) over 48 hours was converted to morphine sulfate equivalents (MSE) using equianalgesic tables

Pain diary was collected at the 2‐week postoperative visit

Statistical analysis was conducted using SAS software Version 9.2 (SAS Institute, Inc., Cary, NC)

21

54 patients enrolled

‐ Exclusion of 1 patient converted to a laparotomy

Cohort 1 – 36 patients

Laparoscopic‐ guided Tap versus trocar infiltration

18 Right sided Tap

18 Left sided Tap

Cohort 2 (in progress)

Ultrasound‐ guided Tap versus trocar

infiltration

9 Right sided Tap

8 Left sided Tap

Figure 2: Flow of enrolled subjects through the study

Cohort 1 n=36

Age , years, mean (SD) 52.6 (12.2)

BMI, Kg/m2, mean (SD) 28.5 (5.6)

Race, n (%)CaucasianOther

31 (86%)5 (14%)

ASA, n (%)123

13 (36%)21 (58%)2 (6%)

Preoperative diagnosis, n (%)Fibroid uterus Adnexal massMalignant or PremalignantOther

9 (25%)13 (36%)11 (31%)3 (8%)

Data shown as mean (SD) or n (%)

Cohort 1 n= 36

Operating time, min, mean (SD) 79.3 (31.1)

Estimated blood loss, mL, mean (SD) 105.3 (75.7)

Procedures:‐ Adnexal only, n (%)‐ LSH +/‐ BSO, n (%)‐TLH +/‐ BSO, n (%)‐ TLH + staging, n (%)

10 (28%)8 (22%)8 (22%)10 (28%)

IOP or Postoperative complications, n (%) 0 (0%)

Time to discharge from the PACU, min, mean (SD)

113.9 (41.2)

Length of hospital stay in days, median [range]

1 [0‐1]

Data shown as mean (SD), median [range] or n (%)

Postoperative pain Tap block side Trocar infiltration side p value

1 Hr 1.9 [0 ‐ 8] 1.7 [ 0 – 10] .75

2 Hr 1.0 [0 ‐ 6] 0.8 [0 – 4] .77

4 Hr 0.8 [0 – 8] 1.1 [0 – 8] .34

6 Hr 0.9 [0 – 6] 1.5 [0 – 9] .30

8 Hr 1.3 [0 – 6] 1.8 [0 – 8] .37

12 Hr 1.1 [0 – 6] 1.5 [0 – 7] .34

18Hr 1.4 [0 – 6] 1.7 [0 – 8] .55

24Hr 1.2 [0 – 6] 1.5 [0 – 9] .94

48 Hr 1.2 [0 – 6] 1.7 [0 – 6] .31

There is no statistically significant difference in pain scores at any time point

Data shown as median (range), and analyzed using the Signed rank test

There is no significant difference in pain scores over time (Tobit model) Figure 3: Narcotic doses in MSE

0

5

10

15

20

Intraop 24h Postop48h Postop

Cohort 1

Literatureplacebo

LiteratureTap block

-The mean narcotic requirement at 24 hours is 8.2mg (SD 7.8mg)

- There is a significant difference between mean narcotic requirement in our study and the mean (15mg) recorded in the literature using placebo Tap block (p.0004)

(De Oliveira et al)

-However no significant difference was found when compared to the mean (11.7mg) recorded in the literature using bupivacaine Tap block (p.06)

(De Oliveira et al)

22

Strengths:‐ The design of the study: randomized , blinded study, using patients as their own controls‐ Adequate sample size, and power‐ Validated instruments (NRS) and objective measures (narcotic use converted to MSE) to assess pain

Limitations:‐ Low pain scores 2ary to IOP analgesia or overall multimodal analgesia ‐ Need to compare laparoscopic guided tap block to ultrasound‐guided tap block

Tap block offered no clinical benefit over local anesthetic port site infiltration in women undergoing gynecologic laparoscopy

Equal and large volumes of local anesthetic administration at trocar sites and Tap block sites may have contributed to the equivalent pain relief

As part of this multimodal analgesic regimen, surgeon‐administered Tap block and trocar site bupivacaine infiltration were equally effective in terms of postoperative pain control

Further randomized studies are needed, and objective measures are particularly valuable because there is bias from anesthesiologists regarding this new technology

1. Wu CL, Rowlingson AJ, Partin AW, Kalish MA, Courpas GE, Walsh PC, et al. Correlation of postoperative pain to quality of recovery in the immediate postoperative period. Region AnesthPain Med 2005;30:516‐22

2. Einarsson J, Sun J, Orav J, Young A. Local Analgesia in Laparoscopy: A Randomized Trial. ObstetGynecol 2004;104:1335‐9

3. Marks J, Ata B, Tulandi T. Systematic reviewand meta‐analysis of intraperitoneal instillation of local anesthetics for reduction of pain after gynecologic laparoscopy. J Minim Invasive Gynecol2012;19:545‐553

4. Siddiqui MRS, Sajid MS, Uncles DR et al. A meta‐analysis on the clinical effectiveness of transversus abdominia plane block. J Clin Anesth, 2011;23:7‐14

5. De Oliveira G, Milad M, Fitzgerald P, Rahmani R, McCarthy R. Transversus Abdominis Plane Infiltration and Quality of Recovery after Laparoscopic Hysterectomy. Obstet Gynecol2011;118:1230‐7

6. Kane S, Garcia‐Thomas V, Alejandro‐Rodriguez M, Astley B, Pollard R. Randomized trial of transversus abdominis plane block at total laparoscopic hysterectomy: effect of regional analgesia on quality of recovery. Am J Obstet Gynecol 2012;207:419.e1‐5

7. Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound‐guided transversus abdominis plane (TAP) block. Anaesthesia and Intensive Care 2007;35,4:616

23

CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as

the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians

(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which

recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws

identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from

discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national

origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the

program, the importance of the services, and the resources available to the recipient, including the mix of oral

and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English

Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,

including those which provide federal financial assistance, to examine the services they provide, identify any

need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every

California state agency which either provides information to, or has contact with, the public to provide bilingual

interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

~

If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.

A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

US Population

Language Spoken at Home

English

Spanish

AsianOther

Indo-Euro

California

Language Spoken at Home

Spanish

English

OtherAsian

Indo-Euro

19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

24

http://www.imq.org/

http://www.usdoj.gov/crt/cor/pubs.htm

http://www.usdoj.gov/crt/cor/13166.htm

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538

Documents

AAGL · Simone Ferrero, MD, PhD ... Moderators: David Eisenstein, M. Jonathon Solnik . Faculty: Sara Y. Brucker, Erica C. Dun, Lena El Hachem, Lenore C. Ellett,