The Why and How of Sterilisation Failures and Mortality

8/11/2019 The Why and How of Sterilisation Failures and Mortality

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WELCOME

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ALL

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DISTRICT FAMILY WELFARE BUREAU

PUDUKKOTTAI


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The Why and How of SterilisationFailures and Mortality

Dr.K.Gomathi,MBBS,DGO

Govt.Hospital,Thirumayam


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Why standards on Sterilisation

Standards on Sterilisation Services ensuresprovision of quality services to the clients

by programme managers and serviceproviders providing permanent methods ofcontraception.


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Counselling

Counselling is the process of helping clientsmake informed and voluntary decisions about

fertility. General courselling should be done whenever a

client has a doubt or is unable to take a decisionregarding the type of contraceptive method to

be used.

However,in all cases,method-specific counsellingmust be done.


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Sterilisation-Explain to the client

It is a permanent procedure for preventingfuture pregnancies

It is a surgical procedure that has apossibility of complications,includingfailurerequiring further management.

It does not affect sexual pleasure,ability,or performance.


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Explain to the client

It will not affect the clients strength or herability to perform normal day-to-day functions.

Sterilisation does not protect against RTIs,STIs,or HIV / AIDS.

Clients must be told that a reversal of thissurgery is possible, but that the reversal involvesmajor surgery and that its success cannot beguaranteed.


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Specificpoints on

surgicaltechniques


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Preparation of the surgical site

The operative area should not be shaved.The hair can be trimmed, if necessary.

The operative site should be preparedimmediately preoperatively with anantiseptic solution,such as iodophor orchlorhexidine gluconate.

Alcohol preparation should not be appliedto the sensitive genitalia.


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Iodophor and chlorhexidine are safe touse on mucous membranes and can be

used to cleanse the vagina and vervix. Iodophor requires 1 to 2 minutes to work

because a certain amount of time is

needed for the release of free iodine,which inactivates the micro-organisms.


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Antiseptic solution should be applied liberally atleast two times on and around the operative

site,which should be thoroughly cleansed bygentle scrubbing.

The antiseptic solution should be applied in acircular motion,beginning at the site of incision

and working ot for several inches.

This inhibits the immediate re-contamination ofthe site with local skin bacteria.


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The excess antseptic solution should notbe permitted to drip and gather beneath

the clients body as this may causeirritation.

After preparing the operative site,the area

should be covered with a sterile drape.


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Important do s and dont s

The operating surgeon should identify eachfallopian tube clearly following it right up to thefimbria.

Excise the tube at the isthmal region only Excision of 1 cm of the tube should be done. Always use a avascular window of the

mesosalpynx(an area without any blood vessels)

for ligation. Use of cautery and crushing of the tube should

be avoided.


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An interval minilaparotomy procedurewould benefit from the use of a uterine

elevator to bring the fallopian tubes intothe operative field.

The incision for a minilaparotomy

(interval,post-abortal,or post-partum )may be transverse or longitudinal.


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A single round or square suture issufficient for tubal occlusion.

Never go round the tube or in betweenthe cut ends unless it is required forhemostasis.


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Before closing the abdomen always ensurecomplete hemostasis.

Look for anomalous or additional falloian tubes. This should be more carefully looked for in cases

of failure of sterilisation.

If there is any problem during the procedurealways DOCUMENT the fact and manageaccordingly in the post op period.


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MOST IMPORTANT DON T

Do not perform

Fimbriectomy as a tubal

sterilisation technique


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Laparoscopy Procedure

To avoid hypoventilation,the patient mustnot be placed in the Trendelenburg

position in excess of 15 degrees.An uterine elevator should be used to

visualize the fallopian tube.

Pneumoperitoeum should be created withVeres needle.


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Insufflation of abdomen with carbondioxide is the prefered method Intra

abdominal pressure must not exceed 15mm of mercury.

Slow insufflations with graded insufflatorand gradual desufflation should be done.

The skin incision should not exceed thediameter of the trocar.


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The trocar is to be angled towards thehollow of the sacrum.

The opeator must lift the anteriorabdominal wall before introducing thetrocar.

Tubal occlusion must always be done withFalopes rings ( no cauery is to be used).


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Precautions to be followed in

applying Falope rings Draw the tube slowly and smoothly into the

sleeve of the laparoscope after properidentification (include only the amount of tube

necessary to provide adequate occlusion). To prevent injury to the mesosalpinx /

tube,avoid pulling up or back on the laparocator. Do not apply rings in case of thick oedematous

or fixed tubes. In such cases,tubal occlusion should be done

with laparotomy by conventional method.


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Precautios to be followed in

applying Falope rings After applying the second ring,the operator

should systematically inspect the pelvis to verify

that both tubes are now occluded that there isunusual bleeding,and that there is no visceralinjury.

The surgeon should expel all the gas from the

abdominal cadvity slowly before removing thetrocar.


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What is failed sterilisation ?

Conception that occurs after sterilisation istermed failed sterilisation.

It can occur several years after the procedure. 10-year cumulative probability of pregnancy of

18.5 per 1000 procedures

(US CREST study; Peterson et al.1996)

8 per 1000 procedures ( canada; Trussell etal.,2003)


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Sterilisation fails due to variation in

The characteristics fo the womenundergoing sterilisation.

Operator experience.

Operating Centre

Sterilisation method chosen


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Sterilisation failure

Although sterilisation failure can occurat any time, the rate of pregnancy after

tubal ligatioon goes up after ten years.Age plays a major role because the

younger the women, the greater are the

chances of failure which could be becausethey are more fertile when compared tothe older women.


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Causes of sterilisation failure

A fistula or re-anastomosis is formed atthe ends of the tube that grows back

together when the gap between them isnot very large.

In cases, where a falope ring is used then

the clamp can get loose or fall offresulting in pregnancy.


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If the tube is not blocked totally o not cutproperly or if the device used for the

occlusion was not placed properly in theright position.

The round ligaments are tied mistakenly

instead of fallopian tubes.


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Cause of sterilisation failure

Obesity or pelvic adhesions might makethe procedure difficult.

Inefficiency or inability of the surgeon tocomplete the procedure effectively orproblem with the equipment.


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The failure rate depends the techniqueused to perform tubal ligation. If the

procedure used causes more demage tothe tubes there is lesser rate of tuballigation failure.

If a procedure causes least damage to thetubes like the use of clamps and cllipsthen they have the highest failure.


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Consequences of sterilisation failure

Women who have udergone sterilisationperformed negligently are entitled to

recover damages according to wrongfulconception,negligence and wrongful birth.

Also, women are entitled to recover

general damages for pain and sufferingduring pregnancy and delivery, and loss ofearnings during pregnancy.


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Common pitfalls in the case sheets

Interval sterilisationLMP not mentioned.

All interval TATsize of the uterus and the

method of uterine elevation should bementioned ( If no elevation is used, the sameshould be documented).

Follow up notes are mostly incomplete. Even the

pulse is not mentioned in the notes.

Most of the case sheets are not discharged.


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Common pitfalls in the case sheets

When LCB is 45 days, , to rule out pregnancy,USG is better than UPT.

In PS case sheets no mention about babys

condition. In Lap sterilisation the no. of rings applied to be

mentioned and the area of the tube where it isapplied.

Lap sterilisation done for a lactating mother (LCB 45 /365). The nature of the tube-edematous, normal ?


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A good case sheet

Under IVS, Incision Sub umbilical. Entry waseasy. Abdomen opened in layers Bil. Tubectomy

done by MPT. After securing completehemostasis, abd. Closed. Skin closed with silk.

Pt. withstood the procedure well.

Followed by prescription and other orders.

Regular nurses notes.

Regular follow up notes for 2 days.


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Confidential enquiry report on

failure Linear salpingectomy done earlier for ectopic

pregnancypartial recanalisation!!. What was

done for that tube ? Evidence of sterilisation absent in one tube

Reason for failurecomplete recanalisation ?

Rings present on both tubesFailure to

sterilise?

Close but not continuous and also Wide apar !! ?


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failures Close but not continuouscomplete

recanalisation.

Previous lap sterilisationboth tubespatentevidence of sterilisation on both tubespresentboth tubes are very close andcontinuousboth rings are present on both

tubesRt. Tubecomplete recanalisation;Lt. tubepartial recanulation ???!!


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failures No mention about ring on one tubecomplete

recanulation.

Evidence of sterilisation present on both tubesleft tuberecanalisation seenReason forfailureComplete recanalisation of right tubeas seen by laparoscopy ?

Ring slipped on the left tubenot seenanywhere in the peritoneal cavity or in anystructure.


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Resterilisation

Ring slipped in one tube position of thering not mentioned- bil.fimbriectomy

done? Signs of sterilisation seen on both sides

bil.fimbriectomy done ?

Evidence of spontaneous recanalisation ofboth tubesbil.fimbriectomy done ?


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Resterilisation

Slipped ring found in the left fimbria and on theright mesosalpinx-bil.fimbriectomy done ?

Left tube2 rings seenright tube-evidence ofrecanalisation seenwhat happened to therings ?repeat lap sterilisation done.

Left side ring seen at the edge of the tube-

bil.fimbriectomy done ?


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Lessons learnt

More care is needed for lap sterilisation.

In lap sterilisation, most of the time, it is

the wrong application of rings which resultin pregnancy.

More number of sterilisation failure in aparticular period needs further study toanalyse the surgeon, technique ormaterials at that time.


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Lessons learnt

Confidential enquiry reports are important.

Needs more care in filling them.

Case sheets are legal documents. What iswritten there is the final word. Henceproper documentation is very important.

Follow up notes with vital monitoring andprescription is MANDATORY.


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Deaths following FemaleSterilisation

The death could be associated with orattrubtable to sterilisation.

A death is attributable to sterilisation is itoccurs within 42 days of sterilisation and resultsfrom a chain of events initiated byanesthesia,operation, or from aggravation of an

unrelated condition by the physiological orpharmacological effects of the anesthesia orsurgery.


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Common causes for deathsfollowing sterilisation

Complications associated with anesthesia(respiratory and cadiovascular

complication) Peritonitis with or without injuries to the

internal organs.

Infection and hemorrhage.


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Can they be prevented ?YES

Minial pre op. evaluation

Asssessing the acceptor before posting her forsurgery(where expertise or infrastructure is lacking refer

them to the higher centre) Hb

Urine Alb, Sugar, Deposits

LMP. USG or UPT before interval procedure

Pulse BP

TemperatureEvidence of peurperal sepsis / sepsis


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Can they be prevented ?YES

Minimal Intr op.monitoring and caution Use of pulse oxymeter or constant monitoring of

the vitals. Use of safe anesthesia technique (LA) Adhering to basic surgical caution while opening

and closing the peritoneum. Identification of the fimbria and the entire length

of the tube before cutting or applying the ring Surgery should never be time bound When in doubt CALL FOR HELP


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A small comparison

US (1977-81)Deaths due to

sterilisation

108

Tamil Nadu

2011 to Till date

35


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To Conclude

It is not sufficient that we work but what we domust also be PROPERLYdocumented.

When in doubt or trouble, always call for help.

When a satisfactory sterilisation could not beperformed, document the same, explain to theclient, advise other contraception and itnecessary send her to a higher centre.

Accept responsiblity for commissions andomissions.


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Documents

The Why and How of Sterilisation Failures and Mortality