Tu bal an astomosis: pregnancy success fo l l owi n g reve rsal of Falope r i n g or monopolar caute ry ste r i l izati on*

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1 Vol., No., July 97 FERTILITY AND STERILITY Copyright <> 97 The American Fertility Society Printed in U.S.A. Tu bal an astomosis: pregnancy success fo l l owi n g reve rsal of r i n g or monopolar caute ry ste r i l izati on* John A. Rock, M.D.t David S. Guzick, M.D.* Eugene Katz, M.D. Howard A. Zacur, M.D., Ph.D. Theodore M. King, M.D., Ph.D. Division of Reproductive Endocrinology and the Section of Reproductive Surgery, The Johns Hopkins Hospital, Baltimore, Maryland The present study reviews pregnancy outcome following tubal anastomosis in pre viously sterilized women. Thirty of women sterilized by monopolar cautery techniques delivered a living child as compared to 9 of women (%) sterilized using the method. Cumulative pregnanoy curves were calculated for the and cautery groups using life-table methods. Following reversal of steriliza tion, the estimated cumulative probability of pregnancy,,, and months after surgery was.%,.%, 9.%, and 7.% respectively. The corresponding estimates following reversal of cautery sterilization were lower at,,, and months following surgery:.7%, 7.%,.%, and 7.9%, respectively. The ectopic tubal pregnancy and spontaneous abortion rate were higher among women sterilized with monopolar cautery. A decreased pregnancy rate was associated with ampullary-isthmic anatomosis in the cautery group; however, pregnancy was least likely to occur in women with shortened oviducts of less than em. Fertil Steril :, 97 In the past, there has been almost complete agreement that tubal ligation should be offered as a permanent method of birth control. However, be cause of unforeseeable circumstances, a woman may wish to re-establish fertility. An increasing number of patients now undergo tubal ligation with mechanical methods, i.e., clip and Silastic, as opposed to surgical tubal excision. Few studies exist that carefully compare results of tubal anastomosis following Silastic versus monopolar cautery methods. In our previous re- Received December 9, 9; revised and accepted March, 97. * Presented at the Society of Gynecologic Surgery, February, 9. t Reprint requests: John A. Rock, M.D., Director, Reproduc tive Endocrinology, Department of Gynecology and Obstetrics, The Johns Hopkins Hospital, Houck 7, Baltimore, Maryland. i Present address: MaGee Women's Hospital, Pittsburgh, Pennsylvania. Vol., No., July 97 port, we noted a decreased pregnancy rate among women following tubal anastomosis who were ster ilized by monopolar cautery. This study compares pregnancy success following tubal anastomosis performed by a single surgeon in women sterilized by either monopolar cautery or methods. MATERIALS AND METHODS This series of patients consists of women pre viously sterilized by unipolar cautery or techiques who were requesting reversal of steril ization from January, 97 to June, 9. Fifty-eight women were sterilized by monopolar cautery techniques; were sterilized by the method. All patients received a preoperative evaluation, including family counseling, hystero salpingogram, timed endometrial biopsy, semen analysis, and/or a postcoital test. Prior to reversal of sterilization, a laparoscopy was performed only when a double- or triple-burn cauterization method

2 of sterilization had been performed or when the technique of sterilization used was in question. Surgical Techniques Tubal anastomosis was accomplished with the use of a microsurgical technique previously de scribed. For the anastomosis 7- (GS micro point spatula needle) polyglactic acid suture, - (DO - l spatula needle) polyglycolic acid suture, or - nylon (BV - Microtaper needle) was used. Magnification of.7 to lox was provided by a loupe and/or OPMI-7 microscope (Carl Zeiss, Inc., New York, NY). No adjunctive therapy was given. The length of the oviduct after anastomosis was mea sured and did not include the interstitial portion of the oviduct. The interval from tubal ligation to reanastomosis was determined by chart review. Statistical Methods Patients' charts, hysterograms, and microscopic slides of proximal and distal segments of oviducts were reviewed. The data were analyzed with the use of a model 7 IBM computer (IBM Corporation, Baltimore, MD). x test with continuity correction and an exact test for X contingency tables were used for comparison of the groups. Life-table methods were used to analyze the like lihood of pregnancy following surgery. Defining the date of surgery as time, observed cumulative pregnancy rates for advancing months of follow-up were calculated according to the method of Berk son and Gage. 7 The observed values of cumulative pregnancy rates for each month of follow-up were then fitted by a parametric model, described pre viously, in which the cumulative probability of pregnancy after n months of follow-up, Pn, is re lated to the cure rate (c) and the monthly probabil ity of pregnancy among those cured (A) as follows: n Pn = c ( - e ). In this model, c represents the ultimate probability of pregnancy following surgery if follow-up were continued for an indefinite pe riod. A separate cumulative pregnancy curve was esti mated for the and cautery groups. Dif ferences between the estimated parameters of the cumulative pregnancy curves for the two groups were tested using a maximum likelihood test. RESULTS Patient Population The patient profile revealed that the majority of patients were Caucasian in each group. Increasing Rock e t al. age and parity did not significantly influence the pregnancy success rate. The duration of the inter val from sterilization to reversal varied from to months. Differences in pregnancy rates at year intervals did not reach a level of statistical significance (Table ). Cumulative Pregnancy Rate The observed cumulative pregnancy curves cal culated from the life tables, as well as curves pre dicted by the model, are shown in Figure for both groups. It can be seen by inspection that the ulti mate probability of pregnancy achieved by reversal of sterilization was higher than that achieved by reversal following cautery sterilization. The estimated cure rate (c) for the group was 9.%, which is significantly higher than the estimated c of.% for the cautery group (P <. ). The estimated monthly probability of pregnancy among those cured, however, was simi lar for both groups (, A =.%; cautery, A =.% ; P = not significant). Thus, the estimated model is suggestive of the conclusion that, among those who ultimately conceived following surgery, the monthly probability of pregnancy was the same, but the proportion of individuals who ultitable Patient Profile Patients viable pregnancy/ total patients Patients viable pregnancy/ total patients Race () White / () 7 () / () Other. Age (yrs) a b - / ( ) 7/ () 7/ () 7-9/ () /9 () - / () -9 / (7) / () Parity ( ) / (7) / () / () / () / () / () 7 (7) / (7) ;;;,: Duration of interval from sterilization to reversal (mos) - / () / () - /7 (7) / ( ) 9-7 / () / () 7 9/7 () / () Mean age (range) cautery: (- 7 ) ; : (-9). Not significant. Mean interval (range) cautery: 7 (-); mos (-). Fertility and Sterility

3 W > :: u <...I o Z < Z " w a: n. in the group where all tubes were > em in length (Table ). All women with < em of oviduct in the cautery group required an ampul lacy-isthmic anastomosis. Thus, the reduced preg nancy rate in the cautery group may be a function of reduced tubal length rather than the segments anastomosed. w < a: Associated Tubal Pathology in Women Sterilized by Monopolar MONTHS OF FOLLOW-UP Figure Life-table analysis: cumulative pregnancy rate fol lowing and monopolar cautery (e, ;. monopolar electrocoagulation). mately conceived was much greater for the group. Forty -five ( 7 % ) of women sterilized by monopolar cautery had associated pelvic pathology as compared with 9 ( % ) of women sterilized by the method. Endometriosis and tubal fistula were more common in the cautery group (Table ). The pregnancy rate among women with associated disease was similar to that of those with no abnormal pathologic findings (nonsignificant). DISCUSSION Pregnancy Outcome The gross viable pregnancy rate was significantly increased following reversal of steril ization when compared with monopolar cautery. The increase in the spontaneous abortion and ec topic pregnancy rates in each group was not signifi cantly different (Table ). Length o f Tubal Segment A reduced pregnancy rate was noted where a single remaining oviduct or both oviducts were :::;; em (P <.) among women sterilized with mono polar cautery (Table ). All women sterilized by the method had > em of fallopian tube. Site of Tubal Anastomosis Pregnancy success in the cautery group was most likely to occur where anastomosis was performed without tubal discrepancy. This was not observed Table In this report, other factors known to influence pregnancy success after sterilization were consid ered with each sterilization method. The patient population in each group was comparable. All pro cedures were performed by a single surgeon, thus limiting the degree of variability in the surgical technique required to achieve a satisfactory anas tomosis. The site of anastomosis was not a factor in subsequent pregnancy success with sterilization. In the cautery group, however, tubal length and site of anastomosis influenced the pregnancy rate. Tubal length has been noted to be an important factor that influences pregnancy success. Previous reports have noted a reduced viable pregnancy rate among women with oviducts < cm. Interest ingly, neither a reduced abortion rate nor an in creased tubal pregnancy rate were noted in women with shortened oviducts. In our series of women, it Pregnancy Success Following Reversal of Sterilization (The Johns Hopkins Hospital, 97 to 9) Method of sterilization No. of patients Outcomes of total pregnancies No. of pregnant patients Patients with living children * pregnancies Monopolar 9 (7) 9 () ( ) 9 () (7) 9 () 7 9 *P :s;.. Vol., No., July 97

4 Table The Effect of Tubal Length on Subsequent Pregnancy Success in Women Sterilized by Monopolar with living children' pregnancies One or both tubes < em One or both tubes > em ( 9% ) (7% ) (% ) (% ) All women sterilized by method had > em of oviduct. One tube < em and the other > em. ' C hi-square analysis P :s;.. was possible to partially separate the influence of these factors. A reduced pregnancy rate was noted where a single remaining oviduct or both oviducts were < em. All women with < em of oviduct in the cautery group required an ampullary-isthmic anastomosis, perhaps explaining why a reduced pregnancy rate was noted among women in the cautery group where ampullary-isthmic anasto mosis was performed. The pregnancy success following ampullary isthmic anastomosis in the group was comparable to those methods where there was no discrepancy with tubal lumen. There were no ovi ducts of < em in the group. Therefore, the influence of reduced tubal length in the group could not be compared with the cautery group. Only in the worst circumstances is tubal length < em after Silastic application, i.e., multiple applications to a single oviduct. In the final analysis, we may never be able to assess the actual influence of tubal length on pregnancy suc cess because reduced tubal length is seldom present Table following sterilization with mechanical occlusive devices. Gomel9 suggested that tubal length may not alter pregnancy success. However, an inverse relation ship existed between total length of the oviduct and the interval between the surgery and the occur rence of pregnancy. This relationship was not evi dent in our series or that reported by Paterson. Our findings concur with Gomel's9 suggestion that the site of anastomosis does not significantly influ ence pregnancy success. Associated tubal pathology in women sterilized by monopolar cautery was higher than those steri lized by methods. The incidence of en dometriosis, fistula formation, and chronic inflam mation in the proximal portion of the oviduct was notably higher in women sterilized by cautery. These findings confirm our previous. observation that a higher percentage of endometriosis and fistulas may be noted in women who have < em of proximal tubal segment and who were sterilized by electrocautery methods. These changes do not ap pear to influence the pregnancy success rate. This report addresses only the reversibility of the method of sterilization. A Population Reports noted eight reported cases of reversal of Silastic sterilization. There were six intrauter ine pregnancies. Since this review, additional pub lications have noted a higher pregnancy success with reversal of Silastic sterilization. More re cently, Paterson noted a 7% viable pregnancy rate among women following reversal of Silastic sterilization. Other mechanical occlusive de vices have met with similar success. An accumu lated series of Hulka clip reversals revealed an 7% viable pregnancy rate. More recently, Pater son noted a viable pregnancy in six of seven women following clip reversal. An equally high suc cess rate has been reported with the Filshie clip. Pregnancy Success with Respect to the Anastomosis of Tubal Segments Isthmic/isthmic Reproductive performance Ampullary /isthmic s Mixed FaJ.ope ( %) ( % ) (7% ) ( % ) 9 (%) with living children pregnancies 7 ( % ) 7 ( % ) ( % ) (% ) Ampullary/ ampullary I Fertility and Sterility

5 Table Coexisting Disease Noted at the Time of Reversal of Sterilization Endometriosis () Fistula 9 (9) Chronic inflammation () Inclusion cyst () Adhesions () Proximal hydrosalpinx () () (O) (7) () () (7) Disease noted among and oviducts sterilized by cautery or, respectively. Thus, mechanical occlusive devices that destroy a small portion of the oviduct appear to have the highest viable pregnancy rate after anastomosis. Our experiences suggest that reversal of sterilization following cautery offers a reduced pregnancy rate when compared with the method. A lower viable pregnancy rate was noted as well. An increased tubal ectopic pregnancy rate, which was independent of tubal length, was noted in the cautery group. Poor outcome may be a result of the amount of tubal destruction. Donnez et al. have noted pathologic changes and em from the unipolar electrocoagulated areas of the oviduct. One hour after electrocoagulation, there were peritoneal vesicles containing clear fluid along the entire length of the fallopian tube and spreading on to the broad ligament, implying damage had spread well beyond the target area. These results may explain the variability in tubal destruction. Thus, the increased frequency of ampullary-isthmic anastomosis among shortened oviducts, associated tubal pathology, and/or unrecognized endocrinologic or neurologic damage to the oviduct may explain the reduced pregnancy rate. REFERENCES. Philips JM, Hulka J, Hulka B, Keith D, Keith L: American Association of Gynecologic Laparoscopist 97 membership survey. J Reprod Med :, 97. Rock JA, Parmley TH, King TM, Laufe LE, Hsu BC: Endometriosis and the development of tuboperitoneal fistulas after tubal ligation. Fertil Steril :, 9. Jones HW Jr, Rock JA: On the reanastomosis of fallopian tubes after surgical sterilization. Fertil Steril 9:7, 97. Rock JA, Bergquist CA, Zacur HA, Parmley TH, Guzick DS, Jones HW Jr: Tubal anastomosis following unipolar cautery. Fertil Steril 7:, 9. Guzick DS, Rock JA: Estimation of a model of cumulative pregnancy following infertility therapy. Am J Obstet Gynecol :7, 9. Guzick DS, Bross DS, Rock JA: A parametric method for compa cumulative pregnancy curves following infertility therapy. Fertil Steril 7:, 9 7. Berkson J, Gage RP: Calculation of survival rates for cancer. Mayo Clin Proc :7, 9. Silber SJ, Cohen R: Microsurgical reversal of female sterilization: the role of tubal length. Fertil Steril :9, 9 9. Gomel V: Results of reconstructive infertility surgery. In Microsurgery in Female Infertility, Edited by V Gomel. New York, Little, Brown and Co, 9, p. Paterson PJ: Factors influencing the success of microsurgical tuboplasty for sterilization reversal. Clin Reprod Fertil :7, 9. Reversing Female Sterilization. Population Reports, Vol. VIII, No., Series C. Population Information Program, Baltimore, MD, The Johns Hopkins University, 9, p C-97. Hulka JF, Noble AD, Letchworth AF, Lieberman B, Owen E, Gomel V, Taft RC, Haney AF, Wheeless CR, Imrie AH, Winston RML, Loeffler FE: Reversibility of clip sterilization. Lancet :97, 9. Filshie GM: The Filshie clip for female sterilization and its reversal (Abstr ). Presented at the th Annual Meeting of the American Public Health Association, Anaheim, California, November -, 9, p. Donnez J, Casanas-Roux J, Ferin J: Macroscopic and microscopic studies of fallopian tubes after laparoscopic sterilization. Contraception :9, 979 Vol., No., July 97 7