sterilization techniques AND discussion on

PRESENTATION MADE FOR POST GRADUATE STUDENTS

1. PERMANENT STERILIZATION An evidence based discussion on surgical techniques Dr. Madura Jayawardane (MBBS, MD, MRCOG) Head of the department & Senior lecturer Department of Obstetrics & Gynaecology University of Sri Jayewardenepura Sri Lanka

2. Scope of the discussion Why sterilization? Which sterilization is better? Male or female? Evidence? Sri Lankan Data versus global data Current Indications for female/male sterilization in SL Surgical methods of female sterilization

3. Cont. Why female sterilization fails ? Added advantages of female sterilization Complications of female sterilization Vasectomy and its advantages, disadvantages & complications. Psychological impact of sterilization Tips and tricks for counselling

4. Sterilization as a contraceptive method Permanent solution for both males and females Often referred as no reversible When they refuse or not suitable to be on hormonal or non hormonal alternatives Limit capacity to expand family

5. Contraceptive efficacy in comparison

6. Is tubal ligation better than vasectomy? Tubal sterilization Vasectomy Failure rate 1/200 (FSRH) Failure rate 1/2000 (FSRH) Reversal success rate-rely on how old the first procedure and patency rate is vary (50-75%) as do pregnancy rate (31%-92%) Reversal success rate-rely on how old the first procedure and patency rate is high (see table 1) Reversal complication – Ectopic Pregnancy No reversal related ectopic risk Reversal technically very difficult Difficulty is less than LRT reversal

7. ******* See references for more details

8. Tubal sterilization Vasectomy Risk of gonadal failure due to post LRT syndrome is described. But controversial. No gonadal failure risk related to vasectomy Relatively not so easy as need to access into abdomen Relatively easy and short procedure at scrotum/groin Immediately effective unless already a fertilization has happened. Not immediately effective. Minimum 8 weeks. SFA should prove azoospermia in 2 post surgery tests. Ovarian cancer risk reduction Chronic prostatic pain with no cancer risk (1/300)

9. Sterilization practices in SL

10. Eligibility criteria in SL General Circular No. 1586 (Issued on 17th August , 1988 ) by DGHS , based on O bservation that a significant proportion of females who have undergone sterilization are under 25 years of age, with a notable number being less than 20 years at that era. Acceptance of a permanent method of contraception at a young age could lead to regrets. S ignificant proportion of females/males had undergone sterilization with two children, the last child still being very young. All institutions and practioners must ensure the appropriate criterion is met before procedure.

11. Who may undergo sterilization in SL? 1.Client should be > 26 years of age with minimum of 2 children and youngest should be > 2 years.(Maternal age must be confirmed with proper document) 2.Client’s age > 26 years with number of children > 3 , can undergo at any time. 3.When client is < 26 years , client’s spouse insists on sterilization and if they have > 3 children, medical officer can proceed sterilization. (after confirming accuracy of provided details of number of children) 4. When sterilization is required for medical reasons, client should be referred to relevant specialist and specialist will finalize the decision.

12. Demographic & Health Survey 2016 - SL C onducted representing all districts and sample size was 18,302 Female sterilization was the mostly used method Male sterilization was the least used method

13. Global trends of sterilization

14. Tubal Sterilization

15. Open or Laparoscopic Sterilization?

16. Open Sterilization Procedure Performed under anaesthesia (SA,GA or LA ) a transverse incision is satisfactory incision made approximately 2–3 cm above the symphysis pubis approximately 2–3 cm in length is satisfactory  fascia is divided transversely rectus muscles are retracted laterally   transversalis fascia and the underlying parietal peritoneum is incised in a vertical fashion

17. To avoid bladder injury, the bladder must be adequately emptied immediately before surgery or an indwelling Foley catheter can be placed  Following the sterilization procedure, the incision is closed in the customary fashion subcuticular absorbable suture is often useful and has excellent patient acceptance

18. Selected chronology of tubal sterilization

19. The Pomeroy, or "modified" Pomeroy Technique

20. the most common method (easy to learn and perform) partial salpingectomy is the end result First accurate identification of the fallopian tube Babcock clamp is placed around the proximal portion of the tubal ampulla and the tube is elevated to reveal the vascular supply of the mesosalpinx  A single strand of absorbable suture material ( 1-vicryl) is placed around the elevated loop of tube and firmly tied

21. F allopian tube is thus ligated and the blood supply is occluded simultaneously A haemostat may now be placed on the suture strands and cut suture Now with clamp you hold the tied tube While gentle traction is maintained on the elevated section of tube scissors is used to pierce the mesosalpinx and approximately 1 cm of tube is excised examined for bleeding and then the tube is returned to the abdominal cavity

22. Simple alternations in modified procedure We start procedure with this clamping approach and rest is same

23. The Parkland Method End result is partial salpingectomy R ather than ligation of a knuckle of tube followed by creation of a window in the mesosalpinx , the window is created first. Thus, procedure is started by identifying an avascular section of the mesosalpinx W hile elevating the tube with Babcock clamps,  window is created below the tube with scissors

24. A 2-cm segment of the mid-portion of the tube is then ligated proximally and distally  as before using 1-vicryl S egment between the suture ligatures is then excised Parkland method provides for immediate anatomic separation of the disconnected tubal segments unlike the Pomeroy technique Failure rates do not differ between these two methods

25. The Madlerner Method High failure rates and no longer in use A loop of tube is elevated and crushed before ligation with permanent suture   No tube portion is excised Let the ligated segment undergoes aseptic necrosis Chance of reconnect is high if suture is slipped or fistula formed between adjacent tube portions

26. The Irving Method-a burring technique I ntroduced as a technique for ligation and division of the oviduct at the time of caesarean delivery D ue to the perceived higher failure rates for traditional tubal sterilization when performed at caesarean C aused by increased hypertrophy and vascularity of the oviducts in the immediate postpartum period A lthough when performed in the puerperal period, it is highly effective and has a low failure rate N ot recommended as an interval procedure

27. T he tube is divided at approximately the ampullary –isthmic junction E nds of the suture are kept long for traction  Using blunt dissection, a tunnel is made within the substance of the uterine myometrium P roximal tube is pulled into this chamber and sutured in place D istal tube is then buried within the substance of the broad ligament Additional sutures may be necessary to close the defect within the mesosalpinx and adjacent broad ligament as a result of the previous dissection

28. The Uchida Technique-a burring method Complex surgery and very less failures

29. A subserosal injection of a saline-epinephrine solution is made in the region of the tubal ampulla The serosa is then incised with the scissors, exposing the muscular layer of the tube A segment of the muscular layer is elevated while the serosa is simultaneously stripped back over the proximal and distal segments The proximal portion of the muscular tube is ligated and excised Ligated segment then drops back beneath the serosa P urse-string suture is placed around the distal tube and tied

30. The Kroener Fimbriectomy Method L igation of the distal ampulla of the tube with two permanent sutures D ivision and removal of the infundibulum of the tube H igh failure rates  

31. The Aldridge Method

32. T he fallopian tube remains intact F imbrial end of the fallopian tube is drawn into a pocket beneath the peritoneum of the broad ligament B uried fimbrial end is then secured in place by several sutures of non absorbable suture material This circle of sutures incorporates the serosal and muscular layers of the tube in the peritoneum of the broad ligament High failure rates

33. Summery of efficacy in different methods Irving and Uchida-very few failure rates + technically difficult (to do in postpartum sterilization) Madlener and Kroener methods are associated with the highest failures Pomeroy’s is the easiest way with acceptable efficacy

34. Post-partum Sterilization Simultaneously at C-section (as   the addition of sterilization to caesarean section adds little to the operative risk of the procedure or to the postoperative morbidity) May be after vaginal birth as immediate procedure or interval procedure O pen surgical techniques are used in immediate procedures When perform as interval procedure, interim method should be considered if necesary .

35. Immediate or Interval Procedure ? Immediate Interval Same hospital admission and convenient for women, recover simultaneously with no added recovery period Need separate admission , 6 weeks later Effective immediately May not, depend on resumed cycles, sexual activity and interim methods Laparoscopy is not feasible due to gravid uterus and infection risk is high Laparoscopy is feasible Failure rate is less when consider 10 year cumulative rate (CREST STUDY) Relatively high

36. Laparoscopic Sterilization Laparoscopic sterilization – YouTube Laparoscopic Tubal Sterilization – YouTube

37. SALPINGECTOMY BY ENERGY DEVICES Dr R K Mishra demonstrating Laparoscopic Sterilization with Harminic Scalpel – YouTube Laparoscopic Tubal ligation or salpingectomy? – YouTube Click on the links for videos

38. Unipolar diathermy should not be used due to hazard risk bipolar., harmonic and ligasure can be used These has less misdirection of energy and reduce thermal damage Simple diathermy coagulation is not advised compare to salpingectomy due to ectopic risk Care must be taken to preserve meso-salphinx which carries vessels to ipsilateral ovary.

39. FALLOP’S RING APPLICATION https:// youtu.be/pIZrMO2Kbho Falope ring applicator aka Laparocator for laparoscopic tubal sterilization: Demonstration – YouTube Laparoscopic tubal ligation or lap ligation or lap sterilization using falope ring - YouTube Click on the links for video

40. Sialstic rubber ring is placed on isthmic part of tube Likely pomeroy technique, but no tissue reduction Surgery may produce significant postoperative pain Direct application of local anaesthetic agent is used for this Need to make sure that we catch full thickness of tube This is difficult as tube is thick and drawing it through ring may tear it This leads to bleeding and failure of procedure

41. FILSHIE CLIP APPLICATION Filshie Clip – YouTube Laparoscopic bilateral tubal occlusion with Filshie clips (for female sterilization) A056 – YouTube Click for video demonstration

42. HULKA CLIP APPLICATION

43. Safe, easy and popular Hulka clip has been replaced with filshie clip Whole width of tube must include Clip is applied closer to uterus than any other procedure For better contraception effect,2 clips can be used 2 clip method is known to cause hydrosalpinx and no longer practiced

44. Reasons for failed female sterilization

45. 1.The ends of a fallopian tube can be recanalised 2.A fistula can develop at the occluded portion of the tube 3.There may be incomplete occlusion of the tube 4.There may be slippage of the occlusive device 5.The occlusive device can be placed on the wrong anatomical structure

46. 6.luteal-phase pregnancies,(which occur when patients are sterilised after unknowingly conceiving in the same cycle as the sterilisation procedure is performed) Iatrogenic luteal-phase ectopic pregnancies can be caused by occluding the fallopian tubes before the blastocyst has passed the site of occlusion Luteal-phase pregnancies are estimated to occur in about 2–3/1000 interval procedures women who used more effective methods of contraception, such as combined oral contraception (COC) or a copper intrauterine device (Cu-IUD), prior to sterilisation had a significantly lower luteal-phase pregnancy rate than women using barrier, fertility awareness or withdrawal methods

47. The CREST Study US COLLABORATIVE REVIEW OF STERILIZATION STUDY-10 YEAR FOLLOW UP STUDY . a multicentre, prospective study conducted in various teaching institutions by the Centres for Disease Control and Prevention (CDC) to examine the long-term failure of tubal ligation for sterilization The study included 10,863 women who enrolled prior to sterilization. After sterilization, these women were followed by annual telephone interviews. They were asked whether they had had a positive pregnancy test or had been told by a physician that they were pregnant since the sterilization

48. If pregnancy does occur after tubal ligation, there is a risk of ectopic pregnancy that varies by technique as well Postpartum partial salpingectomy  = 1.5 per 1000 procedures Bipolar coagulation  = 17.1 per 1000 procedures Silicone band  = 7.3  per 1000 procedures Spring clip  = 8.5 per 1000 procedures

49. Non contraceptive benefits of female sterilization Ovarian cancer risk reduction The most compelling theory of epithelial ovarian carcinogenesis suggests that many serous, endometrioid, and clear cell carcinomas are derived from the fallopian tube and the endometrium and not directly from the ovary women who underwent bilateral salpingectomy had a 65% reduction in the risk of ovarian cancer and women who underwent sterilization had a 28% reduction in risk compared with women who did not undergo sterilization

50. Complications of tubal sterilization Depend on open or minimally invasive methods OPEN LAPAROSCOPIC Wound infection , hematoma common Deaths 1-2/100000 Major complications 4/1000 Convert to open sx 9/1000 Minor complications 8/1000 Infection Bleeding Major organ damage

51. Trans-cervical (Hysteroscopic) Sterilization

52. U sually performed without the need for anaesthesia I nvolves a hysteroscope being inserted into the vagina and cervix vaginoscopically or by using a speculum Flexible micro-inserts ( Essure ) are then passed through the hysteroscope and inserted into the proximal section of each fallopian tube This causes fibrosis and occlusion of tube permanently in 3 months Thus until successful occlusion is proven, back-up contraception is need O cclusion is confirmed by X-ray, ultrasound scan or HSG at least 3 months after the procedure USS is the current choice rather radio images.

53. ESSURE H as a stainless steel inner coil, a nickel titanium ( nitinol ) elastic outer coil and polyethylene (PET) fibres Unsuccessful placement rate may be high as 20%.(After 2 attempts for both tubes) Overall essure failure rate is about 1/500 in 5 year follow up MRI safe up to 3 Tesla Intra-uterine procedure with electro-surgery can be done.(but there is a risk of interruption to essure )

54. C ontraindications for E ssure uncertainty about ending fertility pregnancy or suspected pregnancy delivery or abortion of a second-trimester pregnancy <6 weeks before micro-insert insertion active or recent pelvic infection untreated acute cervicitis unexplained or severe vaginal bleeding known or suspected gynaecological malignancy known abnormal uterine cavity or fallopian tubes that impairs visualization of the tubal ostia or that makes cannulation of the proximal fallopian tube difficult/impossible allergy to contrast media used for HSG women taking corticosteroids.

55. Essure Procedure – YouTube BIRTH CONTROL - ESSURE PROCEDURE – YouTube Click for video

56. Tubal sterilization methods comparison Open LRT Laparoscopic LRT Hysteroscopic Method 0.5% failure 0.3% failure 0.4% failure Need OT Need OT Can do as office procedure Immediate action Immediate action Takes 3-months to work Concomitant abdomen-pelvis assessment Concomitant abdomen-pelvis assessment Concomitant intrauterine assessment More pain Less pain Less pain Widely available Less frequent Less frequent/Not in SL Can perform by reasonably skilled person Surgical expertise need Special training need

57. Psychological impact of sterilization-’’Regret’’ More if it is done in younger age Perform in emergencies with no adequate explanation or time to make informed decision Unmarried Non Caucasian Forcefully performed

58. CREST study -Influenced the global Sterilization Age cutoffs .

59. Sterilization for mentally incapacitated client Sterilization of Women and Girls with Disabilities | Human Rights Watch (hrw.org ) Impossible-suggest LARC No free consent by the women , no sterilization

60. Vasectomy in simple

61. This is a minor , short procedure that can be done in 15 min under LA P revents sperm from reaching the seminal fluid (semen ) M an can still ejaculate, but no sperms. Permanent 1/2000 failure rate Takes 2 months minimum to reach azoospermia and 2 post procedure SFA should prove it. (until such back-up method need) 1/300 risk of chronic prostatic pain

62. Techniques Conventional Vasectomy No scalpel vasectomy Under LA, 2 small 1cm cuts placed on either side of scrotum Popular method, under LA Reach vas, clamp and cut with removal of part of vas Feel the vas and hold it with a small clamp , then make a puncture on the skin to reach vas rather make a long cut Ends can be tied or diathermized Ends can be tied or diathermized Skin suturing and close wounds Suturing is not required

63. Complications Wound infection Orchitis Scrotal (acute) and prostatic pain (chronic) Temporary swelling Sperm granuloma Hematoma Testicles feeling full (temporary sensation by sperms filled epididymis) NO CANCER RISK

64. Tips & Tricks for Counselling Female sterilisation - NHS (www.nhs.uk ) Counseling Issues in Tubal Sterilization | AAFP Clinical Services - Tubal ligation | MSI Australia

65. References Faculty of Sexual and Reproductive Healthcare. (2014). FSRH Clinical Guidance: Male and Female Sterilisation Summary of Recommendations. Retrieved from FSRH.org: http://www.fsrh.org/standards-andguidance/documents/cec-ceu- guidance-sterilisation-summarysep-2014 NHS Choices. ( n.d. ). Female sterilisation . Retrieved 09 16, 2016, from Female sterilisation NHS Choices: http://www.nhs.uk/Conditions/contraception- guide/Pages/femalesterilisation.aspx Male and female sterilization.FSRH,2014.(2019 Reviewed)

66. NHS Choices. ( n.d. ). Vasectomy (male sterilisation). Retrieved 09 19, 2016, from Vasectomy NHS Choices : http:// www.nhs.uk/Conditions/contraceptionguide/Pages/vasectomy-malesterilisation.aspx Prabha S, Burnett Lunan C, Hill R. Experience of reversal of sterilisation at Glasgow Royal Infirmary. J Fam Plann Reprod Health Care 2003; 29 : 32–33. British Association of Urological Surgeons (BAUS). Reversal of Vasectomy: Procedure Specific Information for Patients . London, UK: BAUS, 2012.

67. Shaw’s text book of operative gynecology,7 th Edition . Surgical Procedures for Tubal Sterilization | GLOWM Surgical Sterilization | Clinical Gate Tubal Ligation - StatPearls - NCBI Bookshelf (nih.gov)