PREGNANCY OUTCOME FOLLOWING UTEROTUBAL IMPLANTATION: A COMPARISON OF THE REAMER AND SHARP CORNUAL WEDGE EXCISION TECHNIQUES*

Transcription

1 FERTILITY AND STERILITY Copyright 1979 The American Fertility Society Vol. 31, No.6, June 1979 Printed in U.8A. PREGNANCY OUTCOME FOLLOWING UTEROTUBAL IMPLANTATION: A COMPARISON OF THE REAMER AND SHARP CORNUAL WEDGE EXCISION TECHNIQUES* JOHN A. ROCK, M.D.t* K. PAUL KATAYAMA, M.D. ELIZABETH J. MARTIN, B.A. BARBARA M. ROCK, B.SJ J. DONALD WOODRUFF, M.DJ HOWARD W. JONES, JR., M.D.H Division of Reproductive Endocrinology and Infertility, Department of Gynecology and Obstetrics, The Johns Hopkins University School of Medicine, and Department of Biostatistics, The Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland The present study reviews the pregnancy outcome in 52 patients treated with uterotubal implantation for intramural or isthmic obstruction. Twenty-six patients were treated with the sharp cornual wedge technique, four of whom conceived for a pregnancy rate of 15%. Within this group, 20 patients had the isthmic portion and 6 patients had the ampullary portion of the fallopian tube implanted into the uterus. The pregnancy rates were 1'5% and 17%, respectively. An additional 26 patients were treated by the reamer technique, 11 of whom (42%) conceived. Of the 26 patients treated with the reamer technique, 15 had the isthmic portion of the fallopian tube implanted into the uterus and 11 patients had the ampullary portion of the fallopian tube implanted. Pregnancy rates were 27% and 64%, respectively. Over-all, 52 patients were treated with uterotubal implantation, 15 of whom conceived for a pregnancy rate of 29%. Eight patients (15%) had pregnancies which resulted in living children. The reamer technique (implanting the ampullary portion of the fallopian tube) appeared to give the best results in achievement of pregnancy, although this did not reach a level of statistical significance. Adhesion formation involving the fallopian tube and ovary noted at the time of uterotubal implantation was categorized according to a classification based on the extent and the site of the adhesion formation. Pregnancy was less likely to occur in those patients with fixation of the ovary and tube and obliteration of the cul-de-sac (P < 0.05). Fertil Steril31:634, 1979 Received April 3, 1978; revised October 2, 1978, and January 10, 1979; accepted February 15, *Presented at the Thirty-Fourth Annual Meeting of The American Fertility Society, March 29 to April 1, 1978, New Orleans, La. treprint requests: John A. Rock, M.D., Department of Gynecology and Obstetrics, The Johns Hopkins Hospital, Baltimore, Md *Division of Reproductive Endocrinology and Infertility, Department of Gynecology and Obstetrics, The Johns Hopkins University School of Medicine. Present address: Department of Obstetrics and Gynecology, The Medical College of Wisconsin, Milwaukee, Wisc. Department of Biostatistics, The Johns Hopkins University School of Hygiene and Public Health. l/present address: Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, Va. Successful pregnancy following uterotubal implantation is thought to be dependent upon operative technique, extent of adhesion formation, tubal pathology, and pre- and postoperative management. Comparison of results is difficult because of the lack of homogeneous patient groups having the same basic etiology for proximal obstruction. In addition, confusion in comparisons is created by the optional use of different splinting techniques. As a result of these variables, it is difficult to establish the advantage of a particular technique by simple comparison of pregnancy success rates. The purpose of this report is to evaluate the resolution of infertility in patients with intramural and 634

2 Vol. 31, No.6 PREGNANCY OUTCOME FOLLOWING UTEROTUBAL IMPLANTATION 635 isthmic obstruction treated by cornual implantation of the isthmic or ampullary portion of the fallopian tube, using the sharp cornual wedge excision or the reamer technique, and to relate the pregnancy results to the extent of adhesion formation. This institution previously reported experience with uterotubal implantation with emphasis on the factors which influenced pregnancy outcome. I - 3 Although the general categories of tuboplastic procedures were discussed in these previous reports, none provided an in-depth study of a particular type of tuboplastic surgery. The present report re-examines those patients previously reported and adds new patients in an attempt to provide further insight into the factors influencing pregnancy success. MATERIALS AND METHODS Patient characteristic Wedge TABLE 1. Patient Population Implantation technique Reamer A\1 (yr) ean Range Race White 65% 69% 67% Other 35% 31% 33% Parity 0 50% 27% 38% 1 or more 50% 73% 62% The present series consists of a historic prospective analysis involving patients treated with uterotubal implantation from January 1, 1942, through December 31,1976, during which time 75 patients with proximal obstruction were evaluated by the Department of Gynecology and Obstetrics of The Johns Hopkins Hospital. A review of operative notes, hysterograms, and histories allowed patient categorization. Fifty-two patients provided adequate documentation for inclusion into the study. The ampullary or isthmic portion of the fallopian tube was implanted into the uterus by the reamer or sharp cornual wedge technique. All patients received a thorough evaluation in an attempt to identify the factors which might explain their infertility. All had been infertile for at least 1 year prior to evaluation. The infertility evaluation included either a hysterosalpingogram and/or Rubin's test, documentation of ovulatory status, postcoital test, and analysis of the husband's semen. Patients included in this study were considered infertile as a result of proximal obstruction documented with at least two tests evaluating tubal patency. Twenty patients were evaluated with endoscopy prior to laparotomy. All patients received bilateral uterotubal implantation or unilateral operation on a residual fallopian tube. A normally fimbriated portion of the fallopian tube was considered a prerequisite for uterotubal implantation. Mean ages of patients receiving uterotubal implantation by the sharp cornual wedge technique or the reamer technique were similar (Table 1). Differences in race, parity, duration of infertility, and extent of disease between the wedge and reamer groups were not significant. Total P value NSa NS NS Duration of infertility (mo) Mean Range NS Extent of adhesion formation Mild 13 (50%) 16 (62%) 29(56%) Moderate 5 (19%) 5 (19%) 10 (19%) NS Severe 8 (31%) 5 (19%) 13 (25%) ans, Not significant.

3 636 ROCKETAL. June 1979 TABLE 2. Classification of Extent of Pelvic Adhesion Formation in Patients with Intramural or Isthmic Obstruction Undergoing Uterotubal Implantation Extent of disease Mild Moderate Severe Findings 1. Minimal or no peri tubular adhesions 2. No fixation of the ovaries or tubes 3. No cul-de-sac adhesions 1. Substantial peri tubular and periovarian adhesions without fixation 2. Minimal cul-de-sac adhesions 1. Dense pelvic or adnexal adhesions with fixation of ovary to the broad ligament or pelvic side wall 2. Obliteration of cul-de-sac Classification of Extent of Adhesion Formation. A classification system was devised incorporating the extent of adhesion formation involving the tube, ovary, and cul-de-sac (Table 2). Mild disease was characterized by minimal or no peri tubal adhesions. The moderate category included substantial peritubular and periovarian adhesions without fixation, and minimal or no cul-de-sac adhesions. The severe group consisted of dense pelvic or adnexal adhesions with fixation of ovary to bowel, broad ligament, or pelvic sidewall and obliteration of the cul-de-sac. Most patients treated with uterotubal implantation had mild or moderate disease; approximately 25% had severe disease. The extent of disease was categorized with reference to the worst feature. Proximal obstruction with abnormal fimbriae and/or distal fimbrial obstruction were considered contraindications to tuboplasty. Description of the Technique of Uterotubal Implantation. Proximal obstruction of the oviduct required implantation of either the isthmic or ampullary segment into the uterine cavity. When an ampullary implantation was desired, the segment of isthmic fallopian tube was excised. Implantation was performed with at least 5 cm of fallopian tube, leaving approximately 3 to 4 cm extruding from the cornual area. The interstitial portion of the fallopian tube was excised as a wedge-shaped piece of tissue with a uterine defect sufficient to permit insertion of the distal fallopian tube into the uterine cavity. Alternatively, a 5-, 7-, or 9-mm reamer was used to remove the interstitial portion of the tube. The prosthesis was looped as a ring and brought into the cavity, and the other portion of the splint was brought out through the uterine defect on the opposite side. If a unilateral implantation was performed, there was no need for that limb of the prothesis and it was removed. A no. 28 wire guide was placed into the Teflon or polyethylene splint to lend rigidity as well as radio-opacity and to prevent expulsion. When a straight splint was used, it was either brought through the cervix, where it was sutured, or brought out through the anterior abdominal wall and secured. A small lacrimal duct probe was gently inserted through the fimbrial portion of the distal segment of oviduct. The splint was attached to the probe and pulled through the tubal lumen. The end of the fallopian tube to be implanted into the uterus was then split longitudinally for a distance of approximately 0.5 cm. A suture of 5-0 chromic catgut or Dexon was then placed through the edge of each end. One split end of the tube was sutured in an anterior direction so that two sutures were brought out through the anterior uterine wall, whereas the other two were brought out through the posterior uterine wall. The looped or straight splint was left in place for 2 to 6 months. If the loop technique was used, the splint was removed in the office with a Novak endometrial curette. If the polyethylene catheter was brought out through the abdominal wall, it was removed in an outpatient setting with local anesthesia. Postoperative pseudopregnancy was not used. A postoperative hysterogram was obtained in most instances approximately 1 or 2 months after removal of the splint. Statistical Methods. After a classification system had been formulated for the extent of adhesion formation, the patients' charts and hysterograms were reviewed and placed on coding sheets which were submitted to the Department of Biostatistics, School of Hygiene and Public Health, The Johns Hopkins University. The data were then analyzed using a model 370 IBM computer. The life-table method of statistical analysis described in a previous report3 was used to compute the expectancy of pregnancy as well as the cumulative rate of pregnancy over a I-year follow-up. Additionally, a t test with continuity correction and an exact test for 2 X 2 contingency tables were used for comparison of groups. Bartholomew's test for qualitatively ordered proportions 4 was applied to the comparison of pregnancy rates in patients with mild, moderate, or severe disease. RESULTS Of 52 patients, 15 (29%) conceived following uterotubal implantation. Eight patients had pregnancies which resulted in living children. Two patients had tubal ectopic pregnancies. Altogether

4 Vol. 31, No.6 PREGNANCY OUTCOME FOLLOWING UTEROTUBAL IMPLANTATION 637 TABLE 3. Uterotubal Implantation: Fifty-Two Patients with Proximal Obstruction Implantation technique Observation Isthmic Wedge Ampullary No. of patients 20 6 Patients pregnant" 3 (15%) 1 (17%) Patients with living children 2 (10%) 0(0%) Patients with ectopic pregnancy 1 (0.05%) 0(0%) Total Pregnancies 4 1 Living child 2(50%) 0(0%) Abortion 1 (25%) 1 (100%) Ectopic 1 (25%) 0(0%) Isthmic Reamer Ampullary Total (27%) 7 (64%) 15 (29%) 2 (13%) 4 (36%) 8 (15%) 0(0%) 1 (0.09%) 2 (0.04%) (75%) 6(67%) 11 (61%) 1 (25%) 2 (22%) 5(28%) 0(0%) 1 (11%) 2 (11%) "p, Not significant. there were 18 pregnancies, of which 11 (61%) resulted in living children (Table 3). All patients with term pregnancies were delivered by cesarean section. In this series, there were no ruptures of the uterus as a result of a weakening of the uterine wall at the cornua. Of the 26 patients treated with the sharp cornual wedge technique, 20 involved implanting the isthmic portion of the fallopian tube, whereas 6 involved implanting the ampullary portion of the fallopian tube. Over-all pregnancy rates were similar in both groups, although there were no living children in the wedge-ampullary group. Of the 26 patients treated by the reamer technique, 15 had isthmic implantations and 11 had ampullary implantations. The over-all pregnancy rate was highest in the reamer-ampullary group, as was the percentage of living children (Table 3). Over-all, 7 of 35 patients treated with isthmic implantation conceived for a pregnancy rate of 20%, whereas 8 of 17 patients treated with ampullary implantation conceived for a pregnancy rate of 47%. Four patients had living children in each group for pregnancy rates of 11% and 24%, respectively. Pregnancy outcomes were similar in both groups (Table 4). Although the data suggested a difference between the wedge versus the reamer techniques and ampullary versus isthmus implantation, this difference was not statistically significant (J' < 0.10). Splinting Technique. Twenty-two patients were treated with a straight polyethylene splint. Of 22 patients in this group, 6 conceived for a pregnancy rate of 27%. In this group, 4 of 10 hysterograms (40%) confirmed tubal patency. Thirty patients were treated with the ring-splint technique, using no. 28 wire in the Teflon or polyethylene catheter. Of 30 patients so treated, 9 conceived for a pregnancy rate of 30%. Of 19 postoperative hystero- grams, 12 revealed unobstructed tubes for a patency rate of 63%. An advantage to a particular splinting technique could not be demonstrated (J' not significant). The splints remained in place in those patients who did not conceive for an average of3.5 months, whereas the splint remained in place for approximately 3.6 months in those patients who conceived (P not significant). In this series, there were no complications resulting from the splinting techniques. Each prothesis was retrieved without difficulty. Eight patients had irregular bleeding while the splint was in place, but their cycles returned to normal after the splint was removed. Pregnancy following Uterotubal Implantation with Respect to Extent of Disease. Twenty-nine patients with proximal obstruction treated with uterotubal implantation had mild disease. Of these patients, 11 conceived for a pregnancy rate of 38%. Three of ten patients with moderate disease conceived for a pregnancy rate of 30%. Of the 13 patients with extensive adhesion formation, 1 patient conceived. The pregnancy rate was found to be directly related to the extent of pelvic adhesion formation at the time of surgery (J' < 0.05). Of 20 postoperative hysterograms, 13 revealed a pat- TABLE 4. Uterotubal Implantation: Fifty-Two Patients with Proximal Obstruction Ohservation Isthmic Ampullary Totals No. of patients Patients pregnant" 7(20%) 8(47% 15 (29%) Patients with living 4 (11%) 4 (24% 8 (15%) children Patients with ectopic 1 (.03%) 1 (.06%) 2 (.04%) pregnancy Total pregnancies Living child 5 (63%) 6(60%) 11 (61%) Abortion 2(25%) 3 (30%) 5 (28%) Ectopic 1 (12%) 1 (10%) 2 (11%) ap, Not significant.

5 638 ROCKET AL. June 1979 TABLE 5. Pregnancy Outcome and Tubal Patency following Uterotubal Implantation Hysterogram Degree of adhesion No. of Pregnant formation patients u No. of No. with papatients tent tubes Mild (38%) 15 8(53%) Moderate 10 3 (30%) 5 5 (100%) Severe 13 1 (8%) 9 3(33%) Total (29%) (55%) up < 0.05, Bartholomew's test for qualitatively ordered proportions. ency rate of 65% in patients with mild or moderate pelvic adhesion formation. Three of nine patients with extensive adhesion formation had unobstructed tubes for a patency rate of 33% (Table 5). Histologic Diagnosis of Excised Intramural or Isthmic Oviduct. The histologic diagnoses of the excised segments of oviducts are summarized in Table 6. Patients with chronic salpingitis were less likely to conceive following uterotubal implantation. The highest percentage ofliving children was noted in patients in whom salpingitis isthmica nodosa was documented. Estimation of Prognosis by the Modified Life Table Method. The pregnancy results were stated without regard to the length of follow-up, which varied from 1 to 7 years. The results were minimal, as some patients were followed for short periods of time and might have become pregnant at a future date. The data were therefore computerized and expressed as probabilities of becoming pregnant according to an indefinite follow-up. The statistical methods were summarized in a previous report. 3 When expressed in this manner, there was a 38% chance that a patient would become pregnant sometime in the future, but this expectancy decreased to 25% if the patient had not conceived after the 1st year. There was a stepwise increase in the cumulative rate of pregnancy, from less than 1% to 38% at the end of the 4th year (Figs. 1 and 2). TABLE 6. Histologic Diagnosis and Pregnancy Success following Uterotubal Implantation Histologic diagnosis No. of Patients Living patients pregnant children Chronic salpingitis 21 5 (24%) 2 (10%) Sterilization 12 4 (33%) 2(17%) Salpingitis isthmica 11 4(36%) 4(36%) nodosa Normal histology 3 1 (33%) 0(0%) No pathology report 5 1 (20%) 0(0%) Total (29%) 8 (15lh)!... >- '-' c c 01 30!l. '0 >- '-' c 20 E '-'! >< UJ '\ - Uterotubal Implantation (52 cases) \ '----\ -'- '---- \.-e-e-. \.-e-. \ -or Months after Treatment FIG. 1. Expectancy of pregnancy. DISCUSSION Basically, three types of uterine incisions are used for the creation of a stoma for tubal implantation. Bonney5 advocated sharp excision of a cornual wedge prior to implantation. Holden and Sovak 6 advocated the use of a reamer to make a cornual opening prior to implantation. There have been numerous modifications of these techniques, including the transverse fundal incision which enables the surgeon to visualize clearly the positioning of the implanted tube as it is sutured in place. 7 Although postoperative patency rates have been reported between 700/0 and 900/0, the term pregnancy rate has been disappointingly low (between 9% and 48%) (Tables 7 and 8). Most recently, Von Csaba et al. 8 and Peterson et aj.9 have reported 50 C 40 c o c a. ' o :; E Uterotubal Implantation (52 cases) Months after Surgery 50 FIG. 2. Cumulative rate of pregnancy.

6 Vol. 31, No.6 PREGNANCY OUTCOME FOLLOWING UTEROTUBAL IMPLANTATION 639 TABLE 7. Pregnancy Outcomefollowing Uterotubal Implantation (Sharp Cornual Wedge Excision Technique) Author. yr No. of patients Patency rate Shirodkar,t Siegler, Young et ai., Horne et ai.,t Palmer,1O % Ampullary 93 78% Isthmic 26 74% Pregnancy rate Term delivery Technique 25% Fundal incision splint 8% Splint 9% 9% Ring splint 64% 46% Ring splint 44% 38% No splint 42% 33% 46% 43% uterotubal implantation through a posterior fundal incision betwen the utero-ovarian ligaments. Csaba et al. 8 reported that three of nine patients with proximal obstruction due to pelvic inflammatory disease conceived for a pregnancy rate of 33%. Peterson et al. 9 reported a 50% pregnancy rate and a 77% tubal patency rate in 16 patients with obstruction after previous sterilization. There are few reports which compare pregnancy rates following implantation of the isthmic or ampullary portion of the fallopian tube. Palmer 10 reported that in a series of 118 patients who underwent uterotubal implantation for proximal obstruction, there was a 76% patency rate and a 38% term pregnancy rate (Table 7). The term delivery rate was highest in patients having isthmic uterotubal implantations. Palmer 10 advocated the use of the wedge excision technique, implanting the isthmic portion of the fallopian tube into the uterine cavity. Our results suggest that patients are more likely to conceive with the reamer technique when implanting the ampullary portion of the fallopian tube. This observation must be stated with reservation, however, as the groups were small and a statistically significant difference could not be demonstrated between the pregnancy rates in each group. Since Hellman 1 described the use of polyethylene splints in tuboplastic surgery, there have been several series of uterotubal implantations using various splinting techniques (Tables 7 and 8). The splints are usually left in place for 2 to 6 months and removed either from an exit through the abdominal incision or through the cervix. In this series, no difference was found in pregnancy suc- cess following splinting techniques using the straight splint brought out through the abdominal incision or through the cervix as compared with results using the ring splint. Palmer 10 does not advocate the use of splints. He reported that reobstruction was commonly a result of oviduct malposition. Furthermore, Palmer believes that if splints must be used, they should be very thin-o.4 mm in diameter for isthmic implantation. It is our feeling that with careful technique, splinting is helpful in maintaining patency during the healing process. The histologic confirmation ofthe clinical diagnosis of proximal obstruction is not always verified by the pathologist's report of the excised isthmic or intramural portion of the fallopian tube. Grant ll reported histologic observations on 67 excised specimens, of which 87% were of inflammatory origin. Mucosal or insterstitial involvement was found in 49 of 67 specimens. Grant suggested that the obstruction in a number of instances was related to a flaplike type of block and in his view did not represent tubal spasm. Arronet et al. 12 reported 37 specimens from 42 patients who underwent tubal implantation. They indicated that 57% of specimens were of noninflammatory origin. Fifty-seven per cent of these patients conceived following uterotubal implantation. Thirty-eight per cent of the specimens were inflammatory and only thirteen per cent of these patients conceived postoperatively. In our series, 21 patients (40%) had evidence of chronic salpingitis, of whom 5 (24%) conceived. Our findings confirm the observations of Arronet et al. 12 that patients with chronic pelvic inflammatory disease are less likely TABLE 8. Pregnancy Outcome following Uterotubal Implantation (Reamer Technique) Author, yr No. of patients Patency rate Pregnancy rate Term delivery Technique Shirodkar! % 35% Ring splint Hanton et al., % 45% 48% No splint Arronet et al.,t % 43% Ring splint Grant, II % 34% 26% Splint (cervical removal) Umezaki et al., % 38% 38% Ring splint

7 640 ROCKETAL. to conceive following uterotubal implantation. In this series, the extent of pelvic adhesion formation was classified according to the sites and extent of adhesions noted at the time of uterotubal implantation. The pregnancy success rate was in direct relationship to the extent of adhesion formation. Patients with fimbrial obstruction as well as proximal obstruction were considered inoperable. Patients with extensive adhesion formation despite relatively normal-appearing fimbriae with fixation of the length of the tube and the ovary and/or obliteration of the cul-de-sac should be considered poor surgical candidates. It appears that patients with minimal or no adhesion formation with cornual obstruction due to a process other than chronic pelvic inflammatory disease would be provided the best chance for pregnancy. Over the past decade, there has been a decline in the number of uterotubal implantations performed in our institution. With the use of microsurgical technique, Winston 13 has reported cornual isthmic anastomosis with intrauterine pregnancies in 11 of 16 patients. With the development of new surgical techniques for reanastomosis, the use of uterotubal implantation may be restricted to patients with intramural obstruction. REFERENCES 1. Hellman LM: The use of polyethylene in human tubal plastic operations. Fertil Steril 2:498, Crane M, Woodruff D: Factors influencing the success of tuboplastic procedures. Fertil Steril 19:80, Umezaki C, Katayama KP, Jones HW: Pregnancy rates after reconstructive surgery on the fallopian tubes. Obstet Gynecol 43:418,1974 June Fleiss JL: Statistical Methods for Rates and Proportions. New York, John Wiley and Sons, 1973, p Bonney V: The fruits of conservatism. J Obstet Gynaecol Br Commonw 44:1, Holden FC, Sovak FW: Reconstruction of the oviducts: an improved technique with report of cases. Am J Obstet Gynecol 24:684, Shirodkar VN: Further experiences in tuboplasty. Aust NZ J Obstet Gynaecol 5:1, Von Csaba I, Keller G, Magy P, Szabo I: Chirurgische Behandbing der Weiblichen Steriletat Tubenimplantation. Zentralbl Gynaekol 96:490, Peterson EP, Musich JR, Behrman SJ: Uterotubal implantation and obstetrics outcome after previous sterilization. Am J Obstet Gynecol 128:662, Palmer R: Presented to the ad hoc committee on tubal surgery, Thirty-Third Annual Meeting of The American Fertility Society, Miami Fla, Grant A: Infertility surgery of the oviduct. Fertil Steril 22:496, Arronet GJ, Eduljee SY, O'Brien JR: A nine-year survey of fallopian tube dysfunction in human infertility: diagnosis and therapy. Fertil Steril 20:903, Winston RML: Microsurgical tubocornual anastomosis for reversal of sterilization. Lancet 1:284, Siegler AM: Salpingoplasty: classification and report of 115 operations. Obstet Gynecol 34:339, Young PE, Egan JE, Barlow JJ, Mulligan WM: Reconstructive surgery for infertility at the Boston Hospital for Women. Am J Obstet Gynecol108:1092, Horne HW, Clyman M, Debrovner C, Griggs G, Kistner RW, Losasa T, Stevenson CS, Taymore M: The prevention of postoperative pelvic adhesions following conservative operative treatment for human infertility. Int J Fertil 18:109, Shirodkar VN: Contributions to Obstetrics and Gynecology. London, Livingstone, 1960, p Hanton EM, Pratt JJ, Banner EA: Tubal plastic surgery at the Mayo Clinic. Am J Obstet Gynecol 89:934, 1964