A proven new technique for reversal of female sterilization which is cost-effective, highly successful and safe.

Introduction

Tubal sterilization has become the most common form of contraception in married women in the United States (1). It is estimated that worldwide, over 100 million female sterilizations have been performed, and that between 1-3 percent of these women will subsequently desire another pregnancy (2). A change in lifestyles, primarily divorce and remarriage, is the leading cause for further childbearing. The need and demand for reversal of prior female sterilization was thus created.

The technique of microsurgical reversal of female sterilization was developed in the early 1970s, and was available as a clinical surgical procedure by the late 1970s. All of these early surgeries were initially performed as inpatient procedures, necessitating associated laboratory tests, admission forms, lengthy hospitalizations, and the high expense common to inpatient surgery.

A highly successful series of microsurgical tubal reanastomosis (MTR) patients has previously been reported by the authors (3). All patients in this prior study were cared for as in-patients, which was the standard of care in the 1980s. Most of these women were discharged from the hospital within 48 hours of admission. Although the term pregnancy rates were excellent (in excess of 80 percent), the costs of inpatient microsurgery remained high. Since reversal of sterilization is considered an elective and non-covered surgical expense by virtually all insurance companies, a more affordable method of MTR was devised. One year ago, the authors began doing these as outpatient procedures, with discharge within 18 hours after completion of surgery. To date, over 100 patients have had a microsurgical tubal reanastomosis done as an outpatient ambulatory procedure, without complications and total pregnancy rates have been the same as with our prior in-patient MTR procedures.

Selection of patients

Patients were accepted on a random, sequential basis and were requested to bring a copy of their operative and pathology reports from their previous sterilization procedure. This allowed review of the type of prior sterilization performed, and based on the length of removed tubal segments, an estimate of remaining tubal length could be made. Only if these records were not available was a screening laparoscopy advised. The only criteria required for acceptance into our MTR program were a minimal remaining tubal length of 4 cms, evidence of ovulatory function (as assessed by urinary LH surge testing with or without vaginal sector ultrasound for confirmation), and a partner with a normal semen analysis (figure 1).

Preoperative hysterosalpingograms were not routinely obtained, as they only provide an estimate of proximal tubal segment length. Previous sterilization procedures which can be reversed include laparoscopic fulguration (both unipolar and bipolar), Pomeroy procedures, clips, and silastic bands. The only type of prior sterilization which did not qualify for MTR was fimbriectomy. Patients who had received fimbriectomies and/or who had a remaining pre-operative tubal length of less than 4 cms were advised to proceed directly to in vitro fertilization rather than MTR.

Reversal technique

All patients were admitted to the free-standing outpatient surgical facility one hour prior to the scheduled start of surgery and had been fasting for a minimum of 8 hours. A complete blood count was the only laboratory test done, and the blood for this test was obtained at the time the IV was started. A single dose of prophylactic antibiotic (Doxycycline 200 mg IV piggyback) was administered before the patient was taken into the surgical suite. This was given as prophylaxis against possible chlamydial, mycoplasma, or ureaplasma infections, which could produce a subclinical post-operative salpingitis and negate the microsurgical repair. All MTR procedures were done under general endotracheal anesthesia, although epidural anesthesia may also be used. Powder-free surgical gloves should be used by the entire surgical team.

A dual-headed operating microscope with variable magnification was used for all procedures. The use of magnifying loupes is not recommended, both because of operator fatigue as well as the limited field of vision produced. In order to minimize the production of peritoneal microtrauma and subsequent microhemorrhage and adhesion formation, no free intraabdominal sponges or laparotomy tapes of any type were used. Instead, all laparotomy tapes were first placed into sterile polyethylene baggies prior to intraabdominal placement.

Initial repair involved removal of the damaged segment of each fallopian tube, both proximally and distally to the site of occlusion. This was accomplished using either microscissors or scalpel. These were used in preference to diathermy in order to avoid thermal damage to the delicate tubal mucosa. High magnification should be used to inspect the tubal mucosa. If normal mucosa has not yet been reached, further resection of small tubal segments should be performed until normal mucosa (recognizable by the capillary vessels in the mucosal folds) is found. No epinephrine solutions were used, but rather, meticulous hemostasis should be obtained with the use of very fine microbipolar forceps.

All tissues are continually kept moist and irrigated with a solution of ringer’s lactate containing 5000 units heparin/liter solution. This aides in the prevention of clots, with subsequent improvement in surgical field and tissue visualization. (Microbipolar cautery can be easily performed in a wet surgical field).A single suture of 5-0 polyglyconate should be used through the proximal and distal mesosalpinx to bring the tubal segments into direct opposition. This suture prevents tension on the anastomotic site and avoids the need for alignment splints of any type. Splints are to be avoided because of their potential for causing tubal mucosal injury. Our preferred suture materials for tubal anastomosis are 7-0 or 8-0 polydioxanone (PDS Monofilament suture, Ethicon, Inc.) or 7-0 or 8-0 polyglyconate (Maxon, Davis-Geck). The latter suture (Maxon, Davis-Geck) is recommended, insofar as it has minimal suture “memory” which can frustrate even the most experienced microsurgeon.

These sutures are placed in a two-layer, interrupted fashion. The first layer incorporates the edge of the tubal mucosa and muscularis, and the second layer is placed through muscularis and serosa. Careful tying technique should be observed at all times, as these absorbable monofilament sutures require four square knots for security. Peritoneal closure is accomplished with a 3-0 polydioxanone suture placed as a running, nonlocked suture.

Because of its high tissue reactivity and tendency to incite a significant inflammatory reaction with associated adhesion formation, catgut sutures are to be avoided in all microsurgical procedures. The fascial layers are approximated with a running 0-PDS suture, and the subcutaneous tissues first injected with 10-15 ml of 0.5 percent Bupivicaine with 1:200,000 epinephrine solution and then closed with a running nonlocked suture of Polyglactin (Vicryl – Ethicon). The skin can be closed with either staples, tape strips, or a subcuticular suture.

The types of anastomoses performed in this group of patients included intramural-isthmic, intramural-ampullary, isthmic-isthmic, isthmic-ampullary, and ampullary-ampullary. No second-look laparoscopies were performed, and no postoperative hydropertubations were done. With excellent microsurgical technique, these latter two procedures are unnecessary, as the long-term post-operative tubal patency rates will approach 95 percent.

Results

One hundred outpatient MTR procedures done through July 1994 were reviewed, with a minimum of six months follow-up. There were a total of 92 pregnancies, including 6 ectopic pregnancies and 6 spontaneous abortions. Eighty babies were delivered (or are in the third trimester of pregnancy). The total pregnancy rate was 90 percent, with an 80 percent full-term pregnancy rate. Six percent of the pregnancies underwent spontaneous abortion and there was a 6 percent ectopic rate (figure 2).

The average patient was 37 years old, with two prior term deliveries, and the average time from MTR to pregnancy was 7 months (range from 2-19 months) (figure 3). There were no post-operative complications. Of the patients not pregnant, eight are no longer trying (two are over age 40, and two have male factor infertility). No contraception was advised in any patient.

Discussion

A recent, excellent review of the world literature (4) reveals an overall term pregnancy rate of 54 percent following in-patient MTR, with a range of 47.0-78.8 percent. Another extensive report (5) cites a full-term pregnancy rate of 75-93 percent, depending on the portion of tube repaired. Recently published data on outpatient MTR procedures continues to reveal excellent pregnancy rates (6,7) while providing the advantage of significant cost savings. We strongly feel that subsequent post-operative pregnancy rates are primarily related to the surgeon’s meticulous technical skill, with relatively less emphasis on the total post-repair tubal length or type of sterilization procedure reversed.

Post-operative management of all patients involves a follow-up office visit one week after surgery, and again at one month for final wound check. Patients are encouraged to try for pregnancy after their final post-op examination. Patients over age 35 are offered induction of ovulation and monitoring of folliculogenesis using either clomiphene citrate or human menopausal gonadotropin therapy along with vaginal ultrasound and serum estradiol measurements. This approach has been beneficial in accelerating pregnancy rates among women who are oligoovulatory and/or are of advanced maternal reproductive age.

All patients are advised that close surveillance is required if either a missed menstrual period or positive pregnancy test occurs. Early sequential quantitative serum b-hCG titers should be obtained, and once the level reaches 1500 miu (first international reference standard), a vaginal sector ultrasound should be obtained to rule-out the possibility of ectopic pregnancy (8). This is especially important as the incidence of eccyesis is 6 percent following reconstructive tubal surgery. The early diagnosis of ectopic pregnancy allows, in most cases, treatment by laparoscopy, or even non-surgical medical therapy using Methotrexate, avoiding tubal rupture and laparotomy.

Sexuality

Women who have had prior tubal sterilization suffer from a voluntary form of secondary infertility. Their self-esteem and sexual image may, however, suffer. This is especially true when a new partner is involved, as he is usually sexually “intact”. The author’s clinical impression is that women who undergo MTR procedures have an enhanced self-image. This is true even in the women who have not become pregnant following reversal of sterilization.

Summary

A highly successful, safe and cost-effective outpatient MTR program is described. Its advantages include significant financial savings as compared to in-patient surgery, as well as early ambulation and return to normal activities. Term pregnancy rates have consistently averaged 80 percent or better, with total pregnancy rates of 90 percent. Theses results were obtained without the need for preoperative hysterosalpingograms or preoperative screening laparoscopies.

Meticulous surgical technique appears to be the single most important factor in obtaining consistently high pregnancy rates. The concurrent use of minimally reactive absorbable suture materials and avoidance of intraoperative tissue desiccation is important (figure 4). Starch and/or talc contamination from surgical gloves is to be avoided, as is the use of any intraperitoneal sponge or laparotomy tape. If these guidelines are carefully followed, patients will have minimal post-operative pain, thus allowing for rapid (ambulatory) discharge and high pregnancy rates.

And finally, the transition from in-patient to outpatient surgery for microsurgical reversal of female sterilization has resulted in a total cost savings to the patient of almost 50 percent (9).

References:

1. Bachrach, C., Mosher, W. Use of contraception in the United States. 1982, Washington, DC, National Center for Health Statistics; 1984:102
2. Phillips, J., Hulka, J. et al. 1979 American Association Of Gynecologic Laparoscopists Membership Survey. J Repro Med 1981; 26:529.
3. Galen, D., Jacobson, A. A Successful Microsurgical Reanastomosis Program In A Community Hospital. J Repro Med. 31:595, July 1986.
4. Siegler, A., Hulka, J., Petetz, A. Reversibility Of Female Sterilization. Fertil Steril 43:499, 1985.
5. Owen, E. Reversal of Female Sterilization: Review Of 252 Microsurgical Salpingo-Salpingostomies. Med J Aust 141:276, 1984.
6. Galen, D., Jacobson, A., Weckstein, L. A Successful Outpatient Tubal Reanastomosis Program.Pacific Coast Fertil Soc. Mtg, April 1991.
7. Silva., P. et. al. Outpatient Microsurgical Reversal of Tubal Sterilization By A Combined Approach of Laparoscopy and Minilaparotomy. Fertil Steril 55:696, April 1991.
8. Galen, D., Jacobson, A. Early Detection of Normal vs. Abnormal Pregnancies With Vaginal Sector Ultrasound. Presented at the Annual AAGL Meeting, San Francisco, November 1987.
9. Galen, D., Jacobson, A., Weckstein, LN. Outpatient Microsurgical Tubal Reanastomosis. Video J Of Ob/Gyn (VJOG) Vol 5, No 2, March 1992.