Laparoscopic Tubal Occlusion Case File

Laparoscopic Tubal Occlusion Case File

Eugene C. Toy, MD, Konrad P. Harms, MD, Keith O. Reeves, MD, Cristo Papasakelariou, MD, FACOG

Case 7

A 37-year-old G4P3013 woman presents to your office requesting a sterilization procedure. She desires to have a sterilization and would like to have a surgical technique that would allow her to resume her daily duties in a short period of time. Her last delivery was over a year ago, and she has a negative past surgical history. She is 5 ft 4 in in height and weighs 165 lb (75 kg). She is currently using condoms for contraception.

➤ What is the clinical condition?

➤ What counseling is important for this patient?

➤ What is your next step?

ANSWERS TO CASE 7:

Laparoscopic Tubal Occlusion

Summary: This is a 37-year-old G4P3013 woman with a negative past surgical and medical history desiring sterilization.

➤ Clinical condition: Multiparous patient desiring sterilization.

➤ Counseling: The patient should be given the options of contraception, male sterilization, and female sterilization. She should be aware of the irreversibility, failure rate, and risk of ectopic pregnancy with female sterilization.

➤ Next step: Outline the surgical options, including vasectomy, and explain the risks, benefits, and alternatives of the operation.

ANALYSIS

Objectives

1. Be able to provide proper counseling for sterilization.
2. Be familiar with different methods of surgical sterilization and methods of occlusion.
3. Be familiar with risks, complications, and failure rates.

Considerations

This is a 37-year-old G4P3013 woman who desires permanent sterilization. The first step for the physician is to provide proper counseling. It is important for the patient to understand that tubal sterilization is permanent. Despite the availability of surgical techniques that allow the reversal of tubal anatomy and in vitro fertilization, both options are complicated, costly, and not always successful. Sterilization accounts for 39% of contraceptive method used in the United States by women aged 15 to 44 years and their partners. Of those who chose sterilization, 28% had tubal sterilization and 11% had partners who had vasectomy. In comparison, in the same group, 27% use oral contraceptives, 21% use male condoms, 3% use injectable contraceptives, 2% use diaphragms, and 1% use intrauterine devices. Approximately 700,000 tubal sterilizations and 500,000 vasectomies are performed annually in the United States.1 Laparoscopic tubal occlusion is the most common method of interval sterilization in the United States, with approximately 200,000 performed every year. Interval sterilization is defined as a nonpregnant state at least 4 to 6 weeks after the completion of the previous pregnancy. However, tubal sterilization can also be performed postpartum and after a spontaneous or therapeutic abortion. Postpartum sterilization is performed after 10% of hospital deliveries and approximately 3.5% after spontaneous or therapeutic abortions. Postpartum sterilization can be performed at the time of a cesarean section or after a vaginal delivery preferably through a minilaparotomy. Postpartum sterilization optimally involves counseling and informed consent during prenatal care and prior to labor and delivery. The patient should be explained that the sterilization might be postponed in cases of intra- or postpartum medical or obstetrical complications. The physician should be aware of federal and state regulations that govern the timing of consent of the procedure.

Interval sterilization can be performed at any time during the menstrual cycle, although the performance during the follicular phase and/or the use of an effective contraceptive method by the patient greatly reduces the risk of a concurrent pregnancy. In addition, the utilization of a highly sensitive pregnancy test prior to the sterilization is a wise and necessary option. The routine performance of a D&C concurrent with all interval sterilizations is not recommended.

Methods of Laparoscopic Sterilization

Bipolar Coagulation Laparoscopic sterilization has evolved in the United States from the unipolar coagulation originally described by Palmer and Steptoe, to the bipolar techniques described by Rioux and Kleppinger.2 Unipolar sterilization has lost its initial popularity as a result of a series of mysterious bowel injuries that were reported in the 1970s. It is quite possible that these injuries were a result of capacitance coupling (as explained in Case 6) or from mechanical laceration at the time of sterilization. As a result, bipolar laparoscopic tubal occlusion became the most commonly used technique. Approximately 3 cm of the isthmic portion of the fallopian tubes are coagulated using at least 25 W of energy in a cutting waveform (see Figure 7–1). The 3 cm length of the fallopian tubes involved with the sterilization corresponds to the three applications of the bipolar forceps (Figure 7–1). It is imperative to use a current meter (ammeter) to ensure complete desiccation, and this finding of “power used until no current flowed as per ammeter” should be documented in the operative report. Visual inspection can lead to incomplete coagulation of the fallopian tube and increased failures. The tube is grasped approximately 2 to 4 cm from the uterus in order to minimize the possibility of uteroperitoneal fistula formation and ectopic pregnancy. It is probably a good practice to leave a stump of isthmus of approximately 1 to 2 cm after all techniques of sterilization. Coagulation of 3 cm of fallopian tube without division has been demonstrated to be as effective as coagulation and division. Division can lead to bleeding from underlying vessels that were not occluded during the coagulation. Also, coagulation and division may be associated with the destruction of a larger segment of the tube. Division is unnecessary as a result of the normal healing process after bipolar coagulation of the fallopian tube. Bipolar coagulation and the resulting desiccated or devitalized fallopian tissue induce the body to create a state of hypervascularization around the site with gradual absorption of dead tissue

Figure 7–1. Bipolar cautery of the tube on the 3-cm segment. (Reproduced, with

permission, from Schorge JO, Schaffer JI, Halvorson LM, et al. Williams Gynecology.New

York: McGraw-Hill, 2008:937.)

within 3 weeks. The proximal and distal stumps of the desiccated fallopian tube are drawn together as the intervening tissue is absorbed 3 to 6 months after coagulation. Absorption of the dead tissue is usually complete by 6 months, and at that point the two stumps fall apart. Hypervascularization subsides within 1 year. Therefore, with bipolar coagulation within 1 year, there would be an absence of a small segment of the fallopian tube that would have been absorbed. Incomplete coagulation can lead to drawing the stumps together and recanalization within 3 months.

Silastic Band (Falope Ring) Nonelectrical alternatives to tubal occlusion were developed in the 1970s in response to complications mainly associated with unipolar coagulation. In 1974, Yoon and associates3 introduced the silastic band (also called Falope or Yoon ring). It requires an applicator that contains an inner and outer cylinder and grasping hooks. The tube is grasped with the hooks of the Falope ring applicator 3 cm from the uterotubal junction and drawn into the inner lumen of the applicator. As the fallopian tube is drawn inward, the applicator is moved toward the mesosalpinx to minimize tension on the tube and avoid transaction. Thereafter, one silicone band is applied to the grasped segment of the tube by moving the outer cylinder forward. After the application, the grasping hooks are moved forward, thus releasing the occluded segment of tube (Figure 7–2A to C). Inspection is carried out and, if desired, photographic documentation could be carried out. Yoon initially recommended the instillation of indigo carmine dye through the uterine manipulator to ensure proper occlusion. I find this practice unnecessary if the surgeon has achieved a good application. One of the limitations of this surgical option lies with the size and flexibility of the tube and the high incidence of postoperative pain. The application of the ring is not possible in an enlarged or scared tube. It can be associated with transection and/or bleeding. The high incidence of postoperative pain is associated to gradual necrosis from anoxia from the knuckle of tube constricted by the silastic band. In some instances hospitalization is required for pain control and observation. As with electrocoagulation, necrotic tissue stimulates a hyperemic reaction in order to absorb the necrotic tissue adjacent to the loop. The absorption process also takes 3 to 6 months. At 6 months there is usually complete separation of the proximal and distal stumps with the

Figure 7–2A. Falope ring placed on the tube. The grasping prongs are placed in

the mid-portion of the tube and carefully brought into the sheath. (Reproduced,with

permission, from Schorge JO, Schaffer JI, Halvorson LM, et al. Williams Gynecology.New

York: McGraw-Hill, 2008:939.)

Figure 7–2B. The tube is allowed to retract from the applicator sheath, leaving an

ischemic “knuckle of tube.” (Reproduced, with permission, from Schorge JO, Schaffer JI,

Halvorson LM, et al. Williams Gynecology.New York: McGraw-Hill, 2008:939.)

Figure 7–2C. The tube segments are separated after time, achieving the sterilization procedure. (Reproduced,with permission,from Schorge JO, Schaffer JI,Halvorson LM,et al. Williams Gynecology. New York: McGraw-Hill, 2008:940.)

band in its unstretched form covered by peritoneum. However, improper application of the band on the ampulla of the tube may not completely occlude the tube.

Spring Clip The continuous evolution of laparoscopic female sterilization has tried to improve on previous surgical techniques and associated complications of hemorrhage and bowel burns seen with the silastic band and electrocoagulation. The first application in humans took place in 1972. It was tested from 1973 to 1975 in over 1000 patients. The final version was manufactured in 1976 and is known as the Hulka-Clemens Clip (Richard Wolf Medical Instruments Corp., Knittlingen, Germany).4-6 The application requires skill by the surgeon who needs to manipulate both the tube and the clip applicator in order to ensure a correct application across the isthmus of the tube. This task is facilitated through a double-puncture technique and the utilization of a uterine manipulator. Although the device can be applied through a double- or single-puncture technique, the clip is loaded to a clip applier which has a handle and a thumb manipulator (Figure 7–3). The clip is made of Lexan Plastic (Lexan Products Division, General Electric, Mt. Vernon, Indiana) and a gold-plated surgical

Figure 7–3. Spring-loaded clip applied to the tube using an applicator. (Reproduced, with permission, from Schorge JO, Schaffer JI, Halvorson LM, et al. Williams Gynecology. New York: McGraw-Hill, 2008:938.)

stainless steel spring. Advancing the thumb manipulator in a partial position allows for the clip to be secured firmly in the basket and preventing dislodgement during the insertion through a trocar sleeve. Upon obtaining the desired application across the isthmic portion of the tube, the lower ram is moved forward by pushing the thumb manipulator to the fully closed position, closing the C-shaped spring over the upper and lower jaws of the clip. At this point, the clip cannot be removed since it is permanently attached to the tube. Once the spring is in place over the jaws, both lower and upper jaws can be rapidly drawn back into the full open position. Correct application produces Kleppinger envelope sign. The mesosalpinx is pulled upward to the surface of the tube resembling the flat triangular shape of an envelope flap. Moving the applicator downward and away from the tube will facilitate the disengagement of the clip from the applicator. There are no reports of complications from unrecovered clips in the abdominal cavity. The spring clip allows for a gap of 1 mm between the upper and lower jaws at the time of application. The jaws contain teeth that prevent the tissue from rolling out during and after application. Over the next 24 to 48 hours the spring compresses the upper and lower jaws exerting sufficient pressure to squeeze out the fluids out of the cells, thus ensuring necrosis. The process also compresses nerves which can be associated with postoperative cramps. Healing is complete in 6 weeks. The clip is covered by peritoneum. There have been reports of patients allergic to gold that required removal of the clips due to persistent pelvic pain. It should be noted that the utilization of the clip greatly facilitates in the performance of a postpartum tubal ligation.

Additional Options In May 1996, the U.S. Food and Drug Administration (FDA) approved the sale of the Filshie clip (Avalon Medicao Corp., Williston, Vermont). The clip is a hinged titanium clip lined with silastic rubber. It is designed to be applied over the isthmic portion of the tube. Its curved upper jaw is designed to accommodate edematous tubes. It can be applied through a single- or double-puncture technique. The Falope ring, Hulka-Clemens clip, and the Filshie clip are associated with small tubal destruction, thus making tubal reversal a viable option.

In November 2002, the FDA approved the use of Essure (Conceptus Incorporated, Mountain View, California), a new transcervical sterilization device that is placed hysteroscopically. Backup contraception is required for 3 months after the procedure. At that time a confirmatory test (hysterosalpingogram) is performed to ensure occlusion of the fallopian tubes. The procedure can be performed in the office or the hospital. Short-term efficacy studies suggest a rate equal or greater than other methods. The limiting steps seems to be the need of expertise in hysteroscopy surgery and the need for backup contraception and hysterosalpingogram 3 months after the procedure.7

In the Essure procedure, a microinsert is placed into the interstitial portion of the fallopian tube under hysteroscopic guidance. The insert consists of an inner coil of stainless steel and polyethylene terephthalate (PET) fibers, and an outer coil of nickel-titanium (nitinol). Therefore, insertion of the device is contraindicated in patients with known nickel sensitivity by skin testing.

The PET fibers elicit a benign tissue response that promotes the invasion of macrophages, fibroblasts, foreign body giant cells, and plasma cells. The tissue reaction and the resulting fibrotic ingrowth around the device produce complete tubal occlusion. Bilateral tubal placement rate is 94.6%, although rates as high as 99% have been reported. Essure is highly efficacious with no pregnancies reported in combined data from the phase II and pivotal trials.

In 2009, the FDA approved the second method of transcervical sterilization, Adiana® Permanent Contraception System (Hologic, Inc., Bedford, MA). The Adiana sterilization method consists of a combination of controlled thermal damage to the lining of a small segment of the fallopian tube followed by insertion of a non-absorbable biocompatible silicone elastomer matrix within the tubal lumen. Under hysteroscopic guidance, the delivery catheter is introduced into the tubal ostium. The distal tip of the catheter delivers radiofrequency (RF) energy for 1 minute, creating a 5-mm lesion in the lining of the fallopian tube. Following the thermal injury, the 3.5-mm silicone matrix is deployed within the lesion. Proper deployment of the matrix is identified by the black marker at the tubal ostia and through the position array (PDA). The PDA is a series of 4 sensors that are designed to monitor uniform tissue contact throughout the ablation portion. When the catheter is withdrawn, there are no material visible protruding from the ostia. Occlusion of the tube is achieved by fibroblast ingrowth into the matrix. The system requires the utilization of electrolyte free distending solution such as Glycine or Sorbitol. This raises the risk of excessive absorption and the requirement for a fluid management system and/or careful fluid deficit monitoring. Proper occlusion of the tubes is assessed by performing a HSG 3 months after the procedure. Back up contraception is required. The matrix is visible by ultrasound examination but is not visible through x-ray or HSG. The Adiana system is effective in over 98% cases. However, the 2-year cumulative failure rate is 1.8%, which is higher than all forms of sterilization reported by the CREST study, except for the spring clip application (2.38%), for the same time interval.

Failure of sterilization persists for years after the procedure and varies by method, age, and ethnicity. The younger the patient undergoing the procedure, the higher the failure rate. The U.S. Collaborative Review of Sterilization (CREST) data reported that the 10-year cumulative probability for sterilization failure varied by method and ranged from 7.5 per 1000 to 36 per 1000 procedures. The 5- and 10-year cumulative pregnancy rates per method are as follows:8

Postpartum partial salpingectomy: 6.3 per 1000 and 7.5 per 1000 procedures

Bipolar coagulation: 16.5 per 1000 and 24.8 per 1000 procedures

Silicone band: 10 per 1000 and 17.7 per 1000 procedures

Spring clip: 31.7 per 1000 and 36.5 per 1000 pregnancies

A secondary analysis of the 5-year failure rates with bipolar coagulation has shown a higher rate of 19.5 per 1000 procedures from 1978 to 1982, as compared to a rate of 6.3 per 1000 procedures from 1985 to 1987. This could be explained on the basis of utilization of an ammeter during bipolar coagulation of the fallopian tubes.

The risk of an ectopic pregnancy is higher after bipolar coagulation than postpartum salpingectomy. It could be a reflection of the technique. The overall risk of an ectopic pregnancy by any method is 7.3 per 1000 procedures. The probability of an ectopic pregnancy is greater for women sterilized before the age of 30 years. If a patient has a positive pregnancy test after tubal sterilization, the presence of an ectopic pregnancy should be ruled out.8

There has been a perception that there is higher rate of menstrual irregularities after sterilization. However, prospective studies have found little or no difference at 1 to 2 years of follow-up. The incidence of regret and subsequent desire for reversal seems to be related to age (< 25 years), lack of preoperative information regarding the procedure, lack of information on contraceptive options, pressure from a spouse, and due to medical indications. In terms of sexual interest or pleasure after sterilization, most prospective studies have shown either no consistent change or no improvement.9,10

Comprehension Questions

7.1 A 32-year-old G4P4 woman has had a bilateral tubal occlusion via laparoscopy 2 years previously. She understands that she is at risk for ectopic pregnancy. As compared to women who do not have sterilization, which of the following is most accurate?

A. Female sterilization is associated with a greater risk of ectopic pregnancy.

B. Female sterilization is associated with the same risk of ectopic pregnancy.

C. Female sterilization is associated with a lower risk of ectopic pregnancy.

7.2 Which of the following method of female sterilization is associated with the highest failure rate?

A. Unipolar cautery at laparoscopy

B. Bipolar cautery at laparoscopy

C. Tubal ligation at the time of cesarean

D. Falope ring via laparoscopy

E. Spring clips

7.3 A 37-year-old woman strongly desires female sterilization. She has had numerous abdominal surgeries in the past and has had a ruptured appendicitis previously. Which of the following is the best surgical approach in this patient?

A. Laparoscopic Falope ring

B. Laparoscopic electrocautery

C. Hysteroscopic approach

D. Minilaparotomy with tubal occlusion

ANSWERS

7.1 C.Women who have female sterilization have a lower rate of ectopic pregnancy since there are far less pregnancies than in the nonsterilized cohort. However, if a woman who has had a tubal occlusion does become pregnant, the risk of ectopic pregnancy is fairly high.

7.2 E. Spring clips are associated with the highest failure rate, in other words, the highest pregnancy rate.

7.3 C. Hysteroscopic use of coils in the tubal ostia (Essure) is a good option for patients to avoid the abdominal cavity, given her abdominal adhesions and multiple prior abdominal surgeries. A hysterosalpingogram is recommended following the procedure to ensure that the tubes are occluded.

Clinical Pearls

See Table 1-2 for definition of level of evidence and strength of recommendation

➤ Sterilization by tubal occlusion is chosen by women at a rate of approximately three times that of vasectomy (Level B).

➤ Laparoscopic tubal occlusion is the most common type of female sterilization (Level A).

➤ Bipolar sterilization is best performed using a 3-cm segment of tube (three applications of the bipolar device) and an ammeter to determine that the tissue is adequately desiccated (Level B).

➤ Division of the tube after bipolar cautery is unnecessary and may lead to bleeding (Level B).

➤ The spring clip device is associated with the highest risk of sterilization failure (Level B).

➤ The hysteroscopic placement of coils in the tubal ostia (Essure system), and the insertion of a non-absorbable biocompatible silicone elastomer matrix (Adiana) seems to be effective and can be performed in the office. A hysterosalpingogram needs to be performed to ensure tubal occlusion (Level B).

➤ The incidence of regret after sterilization seems to be associated with age, especially younger than the age of 25 years (Level B).

REFERENCES

1. Piccinino LJ, Mosher WD. Trends in contraceptive use in the United States: 1982-1995. Fam Plann Perspect. 1998;30:10,46. 

2. Pollack AE, Soderstrom RM. Female tubal sterilization. In: Corson SL, Derman RJ, Tyler LB, eds, Fertility Control. 2nd ed. London, ON: Goldin Publishers; 1994:293-317. 

3. Yoon IB, King TM, Parmley TH. A two-year experience with the Falope ring sterilization procedure. Am J Obstet Gynecol. 1977;127:109-112. 

4. Hulka JF, Mercer JP, Fishburne JI, et al. Spring clip sterilization: one year follow-up of 1,079 cases. Am J Obstet Gynecol. 1976;125:1039-1043. 

5. Sokal D, Gates D, Amatya R, Dominik R. Two randomized controlled trials comparing the tubal ring and Filshie clip for tubal sterilization. Fertil Steril. 2000;74:525-533. 

6. Dominik R, Gates D, Sokal D, et al. Two randomized controlled trials comparing the Hulka and Filshie Clips for tubal sterilization. Contraception. 2000;62:169-175. 

7. Bradley L. Long-term follow-up of hysteroscopic sterilization with the Essure Microinsert. Supplement to the Journal of Minimally Invasive Gynecology. Fertil Steril. 2008;15(6):S14-S15. 

8. Peterson HB, Jeng G, Folger SG, Hillis SA, Marchbanks PA, Wilcox LS. The risk of ectopic pregnancy after tubal sterilization. U.S. Collaborative Review of Sterilization Working Group. N Engl J Med. 1997;336:762-767. 

9. Peterson HB, Ory HW, Greenspan JR, Tyler CW Jr. Deaths associated with laparoscopic sterilization by unipolar electrocoagulating devices, 1978 and 1979. Am J Obstet Gynecol. 1981;139:141-143. 

10. Peterson HB, DeStefano F, Rubin GL, Greenspan JR, Lee NC, Ory HW. Deaths attributable to tubal sterilization in the United States, 1977-81. Am J Obstet Gynecol. 1983;146:131-136. 

11. Magnani RJ, Haws JM, Morgan GT, Gargioullo PM, Pollack AE, Koonin LM. Vasectomy in the United States, 1991 and 1995. Am J Public Health. 1999;89:92-94. 

12. Kleppinger RK. Female outpatient sterilization using bipolar coagulation. Bull Postgrad Comm Med Univ Syd. 1977 Nov;33(8):144-154. 

13. Soderstrom RM, Levy BS, Engel T. Reducing bipolar sterilization failures. Obstet Gynecol. 1989;74:60-63. 

14. Fishburne JI Jr, Hulka JF. Tubal healing following laparoscopic electrocoagulation. J Reprod Med. 1976;16:129-134. 

15. Rulin MC, Davidson AR, Philliber SG, et al. Changes in menstrual symptoms among sterilized and comparison women: a prospective study. Obstet Gynecol. 1989;74:149-154. 

16. Shain RN, Miller WB, Mitchell GW, et al. Menstrual pattern change 1 year after sterilization: results of a controlled prospective study. Fertil Steril. 1989;52:192-203. 

17. Wilcox LS, Chu SY, Eaker ED, et al. Risk factors for regret after tubal sterilization: 5 years of follow-up in a prospective study. Fertil Steril. 1991;55:27-33. 

18. Jamieson DJ, Hillis SD, Duerr A, Marchbanks PA, Costello C, Peterson HB. Complications of interval laparoscopic tubal sterilization: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol. 2000;96(6): 997-1002. 

19. Moore CL, Vasquez NF, Lin H, Kaplan LJ. Major vascular injury after laparoscopic tubal ligation. J Emerg Med. 2005;29(1):67-71. 

20. Vancaille TG, Anderson TL, Johns DA. A 12-month prospective evaluation of transcervical sterilization using implantable polymer matrices. Obstet Gynecol. 2008;112:1270-1277. 

21. Levy B, Levie MD, Childers ME. A summary of reported pregnancies after hysteroscopic sterilization. J Minim Invsive Gynecol. 2007;14:271-274. 

22. Connor VF. Essure: a review six years later. J Minm Invasive Gynecol. 2009; 16:282-290.

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