Laparoscopic distal tuboplasty: report of 87 cases and a 4-year experience*

FERTILITY AND STERILITY Copyright e 1991 The American Fertility Society Vol. 56, No.4, Octeber 1991 Printed on acid-free paper in U.S.A. Laparoscopic distal tuboplasty: report of 87 cases and a 4-year experience* Michel Canis, M_D. Gerard Mage, M.D. Jean Luc Pouly, M.D. Hubert Manhes, M.D. Arnaud W attiez, M.D. Maurice A. Bruhat, M.D.t Department of Obstetrics, Gynecology, and Reproductive Medicine, Polyclinique de l'h6tel Dieu, Centre Hospitalier Regional et Universitaire, Clermont-Ferrand, France Objective: To evaluate fertility results after laparoscopic distal tuboplasty and to compare these results with those obtained previously with microsurgery. Design: Retrospective, nonrandomized. Setting: Department of Obstetrics and Gynecology at the University Hospital of Clermont Ferrand, France. Patients: All the distal tuboplasties performed between October 1985 and June 1989 were included. Adnexal damage was assessed using tubal and adhesions scoring systems described previously. Tuboplasty was carried out bilaterally except when one tube was absent or severely damaged (tubal stage III or IV and/or with severe adhesions). Patients with bilateral severe adnexal damages were treated only if they refused to undergo in vitro fertilization. Laparoscopic tuboplasty was performed either with the C0 2 laser or with conventional instruments. Main Outcome Measure: Fertility after laparoscopic treatment was evaluated using simple and cumulative pregnancy rates (PRs) according to the adnexal damage and compared with the microsurgical results using PRs according to the adnexal damage. Results: The overall intrauterine and extrauterine PRs were 33.3% and 6.9%, respectively. Twentysix of the 29 intrauterine pregnancies were obtained within the 1st postoperative year. According to tubal and adhesion stages, the results of laparoscopic distal tuboplasty are similar to those obtained using microsurgery. Conclusion: We conclude that laparoscopic distal tuboplasty, when performed by experienced surgicallaparoscopists, represents an effective alternative to microsurgery. Fertil Steril 56:616, 1991 Received July 13, 1990; revised and accepted June 6, 1991. * Presented at the 46th Annual Meeting of The American Fertility Society, Washington, D.C., October 15 to 18, 1990. t Reprint requests: Maurice Antoine Bruhat, M-D., Department of Obstetrics, Gynecology, and Reproductive Medicine, Polyclinique de!'hotel Dieu, 13 Bd Charles de Gaulle 63033, Clermont Ferrand, France. Significant advances in the laparoscopic treatment of tuboperitoneal infertility have been made in the last 10 years. Several reports have confirmed the value of laparoscopy in the treatment of endometriosis and pelvic adhesions. 1-4 In contrast, since 1977 when Gomel 5 reported four intrauterine pregnancies (IUP) in nine cases of laparoscopic salpingostomy, there have been conflicting reports about the results with laparoscopic distal tubal surgery.6--8 Because laparoscopic surgery is more complicated than microsurgery, the procedure remains controversial. After the initial report on laser laparoscopic salpingostomy by Daniell and Herbert 7 in 1984, we began performing distal tubal surgery by laparoscopy. Three of the first 10 patients treated became pregnant within 6 months after the procedure. This preliminary result encouraged us to perform all the distal tuboplasties by laparoscopy. The retrospective study was undertaken in December 1989 to evaluate this technique and to compare it with laser microsurgery.9-11 616 Canis et al. Laparoscopic salpingostomy Fertility and Sterility

MATERIALS AND METHODS Preoperative Evaluation Between October 1985 and June 1989, 87 patients were treated for distal tubal occlusion with laparoscopy. All the couples underwent a complete infertility evaluation (clinical history, physical examination, basal body temperature chart, semen analysis, hormonal evaluation during the follicular and the luteal phase, and hysterosalpingography (HSG) with a water-soluble medium). Patients with associated proximal tubal lesions were excluded. At laparoscopy, tubal damage was evaluated using a previously reported classification. 9 10 Briefly, this classification is based on three factors: appearance of mucosal folds at HSG, degree of distal tubal occlusion, and appearance of the tubal wall evaluated at laparoscopy. The severity of the disease is staged I, II, III, or IV, with IV being the worst. Adhesions were classified according to the percent of ovary or tube enclosed and the type of adhesions (filmy, vascular, and dense) using a scoring system previously described. 9 10 Each patient was classified according to the most favorable adnexa. 9 10 Laparoscopic diagnosis and treatment were performed during the same operative procedure. The tuboplasty was carried out bilaterally except when one tube was either absent or severely damaged (tubal stage III or IV and/or with severe adhesion). Because fertility rates are low in case of severe tubal damages (stage III or IV) and/or severe adhesions, 9 10 11 in vitro fertilization (IVF) was routinely proposed to these patients. This management was discussed preoperatively with each patient. Patients who refused or otherwise could not undergo IVF were treated by laparoscopy, irrespective of the degree of tubal damage. Operative Procedure Laparoscopy was performed under general anesthesia with endotracheal intubation; the technique of laparoscopy and the instruments (Karl Stortz, Tiittlingen, Germany) used were described previously.12 Adhesiolysis was the first step of the procedure; filmy and dense adhesions were treated using laparoscopic scissors and the C02 laser. To confirm proximal tubal patency, the tubes were distended by transcervical injection using a uterine cannula (Karl Stortz). Three second puncture trocars were used for distal tuboplasty, two were inserted laterally on the suprapubic line (5 mm in diameter), the third (5 or 7 mm in diameter) was inserted medially 3 em above the suprapubic line. Depending on tubal dam- age and/or the operator's preference, salpingostomy was performed using either the C02 laser or laparoscopic scissors and bipolar coagulation. Conventional instruments were generally used for treatment oftubes with thin walls or when the distal tubal scar was easily identified. The C02 laser was introduced medially through a second puncture trocar (7 mm in diameter). Different surgical lasers were used during the study. The laser technique involved filling the posterior cul de sac with saline to serve as a backstop for the beam. After tubal distention, the distal part of the tube was grasped with a traumatic forceps to identify the original ostium. This was opened using a focused shot and a power of 30 watts, and the distal end of the tube was grasped with two atraumatic forceps. The initial incision was extended from the ostium toward the ovary, following the old scar line and avoiding blood vessels when possible. Two additional radial incisions were performed when needed. Additional hemostasis was achieved with bipolar coagulation. Once satisfactory incisions were made, the laser power was reduced to 5 watts, and another hand piece was used to obtain a very low-power density. The serosal surface of the distal tube was coagulated to obtain contraction of theserosa and tubal eversion. 13 The technique using conventional laparoscopic instruments involved opening the tube with highpressure tubal distention or with a fine (the distal end being about 1.5 mm in diameter) and smooth a traumatic forceps introduced gently in the original ostium. The tubal wall was incised toward the ovary, using laparoscopic scissors or two atraumatic forceps pulling carefully and slowly in opposite directions on each edge of one distal tubal scar. This incision was generally bloodless when performed along the previous scars. Coagulation of the serosa performed with a fine bipolar forceps (jaws< 1 mm in diameter) (Micro France, Bourbon l' Archambault, France; or Karl Stortz, Tiittlingen, Germany) was used to evert the incised edges of the hydrosalpinx. To avoid muscular damages, a low-intensity electric current was required. Several extensive peritoneal lavages with warm saline were performed during the procedure. Postoperatively, all the patients received prophylactic antibiotics (doxycycline) and degressive corticosteroid treatment for 7 days. All patients had an uneventful postoperative course. Postoperative hysterosalpingogram or second-look laparoscopy were not performed routinely. Patients were followed up in our department or contacted by phone during December 1989. Since Vol. 56, No.4, October 1991 Canis et al. Laparoscopic salpingostomy 617

Table 1 Fertility by Tubal Stage No. cases IUP EUP Tubal stage Stage I 32 (36.8)" 16 (50) 0 (0) Stage II 37 (42.5) 12 (32.4) 5 (13.5) Stage III 12 (13.8) 1 (8.3) 1 (8.3) Stage IV 6 (6.9) 0 (0) 0 (0) Total 87 29 (33.3) 6 (6.9) Stage I+ II 69 (79.3) 28 (40.6)b 5 (8.7) Stage III + IV 18 (20.7) 1 (5.6)b 1 (5.6) a Values in parentheses are percents. b X 2 = 7.9, P < 0.01; X 2 (Yates)= 6.4, P < 0.02. 1986, most of the patients who failed to conceive 12 to 18 months after the operative procedure were included in our IVF program. For these patients, duration of follow-up was defined as the interval between surgery and December 1989, or the beginning of a pregnancy obtained after an IVF attempt. Our laparoscopic results were compared with our results obtained by microsurgery using C0 2 laser and published previously. 9-11 Statistical significance was tested using X 2 test or Student's t-test where appropriate. In the laparoscopic group, the cumulative pregnancy rate (PR) was calculated using life table analysis. 14 Monthly fecundity rates were calculated according to the method of Cramer et al. 15 RESULTS Eighty-seven patients were included; the mean age was 29.1 ± 4.5 years (range of 21 to 42 years). Fortytwo patients were treated for primary infertility and 45 for secondary infertility. The mean duration of infertility was 33 ± 25.9 months (range from 12 to 120 months). Nine patients had associated male infertility (10.3% ). Six patients had a history of ectopic pregnancy (EP) treated by laparotomy; 29 patients had prior laparoscopic adhesiolysis (31% ). Three patients had a previous microsurgical salpingostomy and 13 a previous salpingectomy or adnexectomy (14.9%). At laparoscopy, the severity of tubal disease was classified as shown in Table 1. Seventeen patients had almost one adnexa without adhesions (19.5%). Among the remaining patients, adhesions were mild in 30 cases (34.5%), moderate in 30 cases (34.5%), and severe in only 10 cases (11.5%) (Table 2). The overall IUP and extrauterine pregnancy (EUP) rates were 33.3% and 6.9%, respectively. Cumulative PRs for the whole group and according to tubal stage are presented in Figure 1. Twenty-six of the 29 IUPs occurred during the 1st year after the laparoscopic surgery, and 93% of the pregnancies were obtained within 14 months. The overall monthly fecundity rate was 2.3%. The monthly fecundity rate was 3.3% during the 1st postoperative year and only 0.6% during the following years (X 2 = 9.8, p < 0.01). Pregnancy rates according to the severity of tubal disease are presented in Table 1. No pregnancy occurred in patients with stage IV disease. The PR in patients with stage III and IV disease (5.6%, 18 cases) was significantly less than that of patients with stage I and II disease (40.6%, 69 cases) (X 2 = 7.8; P < 0.01; X 2 Yates = 6.3; P < 0.02). Intrauterine pregnancy rates according to adhesion stage are shown in Table 2. The EUP rates were 11.8%, 3.3%, 6.7%, and 10% in patients with no, mild, moderate, and severe adhesions, respectively. The IUP rate in patients with severe adhesions (20%, 2 IUP of 10 patients) was not significantly different from the overall result obtained in the other adhesion stages (35.1 %, 27 IUP of 77 cases). Among patients with stage I and II tubal disease, there was no significant difference in IUP rates for patients with no (27.3%), Table 2 Comparison With Microsurgery" Laparoscopy Total 87 Tubal stage Stage I 32 (36.8) Stage II 37 (42.5) Stage III 12 (13.8) Stage IV 6 (6.9) Adhesion stage None 17 (19.5) Mild 30 (34.5) Moderate 30 (34.5) Severe 10 (11.5) IUP Microsurgery IUP 29 (33.3) 76 23 (30.3) 16 (50) 12 (15.8) 8 (66.6) 12 (32.4) 30 (39.5) 11 (36.6) 1 (8.3) 21 (27.6) 3 (14.3) 0 (0) 13 (17.1) 1 (7.7) 4 (23.5) 18 (23.7) 8 (44.4) 14 (46.7) 25 (32.9) 9 (36.0) 9 (30) 15 (19. 7) 5 (33.3) 2 (20) 18 (23.7) 1 (5.5) a All values were not significantly different. Values in parentheses are percents. 618 Canis et al. Laparoscopic salpingostomy Fertility and Sterility

0.6 0.5 0.4 - X----- All patients Tubal stage I Tubal stage 11 Tubal stage Ill 0.3 0.2 0.1 "I' nmllnnnnnl]mnnnn]nnnmn]]nnnnnllnnnnm]nnnnm]nnnmnllnnnnm]nnmnn]nnnnmllnnononl]nnnnm]nmn"nll""'""'llnnonono]nnnmn]o 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 Months Figure 1 Cumulative pregnancy rates. mild (53.8%), moderate (36%), and severe adhesion (28.6%). Thirty-four patients (39.1% ), including 13 with a previous salpingectomy and 21 with a too severely damaged adnexa, had only one patent tube after laparoscopy surgery. Fifty-three (60.9%) had a bilateral procedure. Although the severity of tubal disease was significantly worse in patients having only one patent tube (P < 0.01, comparison of the percentage of patients with stage I and II tubal disease), the PR (29.4%) was not significantly different from patients with bilateral tubal patency (35.8%). Forty-seven patients were treated only with the C0 2 laser, 31 without the laser, and 9 with both techniques. Pregnancy rates were 29.8% in the laser group, 32.3% in the nonlaser group, and 55% in the group treated with both techniques not significant. These three treatment groups were similar according to the severity of tubal and adhesive diseases. Table 2 includes previously reported data on C02 laser microsurgical distal tuboplasty.u These historical control and laparoscopy-treated patients were similar for age (microsurgery: 26.8 years, range 20 to 38; laparoscopy: 29.1 years, range 21 to 42) and duration of infertility (microsurgery: 32 ± 23.4 months; laparoscopy: 33 ± 25.9 months). As expected, the severity of tubal disease was greater in patients treated with microsurgery (X 2 = 14.04, P < 0.01), but PRs according to tubal and/or adhesions stage showed no statistical difference between the two groups (Table 2). DISCUSSION In the 1970s, significant advances in the treatment of distal tubal occlusion were made with the development of microsurgery showing the advantages of careful hemostasis, minimal and gentle tissue handling, constant peritoneal irrigation, and magnification. Any new surgical treatment should obtain almost the same results and provides new advantages for the patients. In the present study, the overall IUP rate after laparoscopic salpingostomy was 33.3%. These results can be compared favorably with the results obtained by microsurgery.16 Because the results of tubal surgery are mainly related to the severity of tubal damages, 9 10 17 we compared our results according to the severity of tubal and adhesive disease, using a classification that we described previously.9 10 We found no difference in PRs between microsurgery and laparoscopy (Table 2). Unfortunately, we were unable to construct life table analysis for the patients treated with microsurgery. Because 86.7% of the pregnancies were obtained during the 1st postoperative year after laparoscopic salpingostomy (Fig. 1), comparison of PRs is interesting despite the shorter follow-up in the laparoscopic group. So, we believe that in experienced hands, laparoscopic surgery represents a safe and effective alternative to microsurgery for the treatment of distal tubal occlusion. Obviously, prospective randomized studies would be necessary to compare microsurgery and laparoscopy and to enable a definitive conclusion. Vol. 56, No.4, October 1991 Canis et al. Laparoscopic salpingostomy 619

When compared with classical procedures performed by laparotomy, laparoscopic surgery has several widely accepted advantages including minimal physical stress, shorter hospitalization time, and reduced costs. Furthermore, when using laparoscopy, diagnosis and treatment are always achieved during the same operative procedure. Because the abdomen is not opened, laparoscopy avoids drying of the peritoneum and decreases the potential for infections.18 19 This may reduce postoperative adhesion formation, but experimental data to confirm this remain controversial.20 21 Recently, an experimental study from Luciano et al.21 clearly established that if careful hemostasis is achieved, postoperative adhesions are significantly decreased after laparoscopic procedures. Although we found no correlation between PR and the severity of the adhesive disease in patients treated by laparoscopy, this theoretical advantage of laparoscopy was not definitively demonstrated by our results. Indeed, the difference we found between laparoscopy and microsurgery (Table 2) in patients with severe adhesive disease was not statistically significant and was probably explained by a higher rate of patients with stage I and II tubal disease in the group treated by laparoscopy. Further studies are required to enable a definitive conclusion about the possible advantage of laparoscopy in the treatment of severe adhesions. The first reports of laparoscopic distal tuboplasty appeared promising. The PRs were 44% and 26% in the studies of Gomel 5 and Mettler et al., 6 respectively. Daniell and Herbert 7 obtained a 19% IUP rate after laser laparoscopic treatment of recurrent hydrosalpinx. In contrast, Fayez8 obtained only 10% of EP after laparoscopic salpingostomy and coneluded that the laparoscopic technique was too traumatic for the tube. Salpingostomy is one of the most difficult laparoscopic procedures, and operative difficulties may explain most of the controversies about this technique. The expertise of both the sur geon and the first assistant is likely a critical determinant of success. As pointed out previously, experience in laparoscopic surgery is neither created nor developed overnight,22 and we agree that laparoscopic salpingostomy may be detrimental if performed by laparoscopists with only average experience.8 In our experience, most of the operative difficulties are related to the mobility of the fimbria. Laparoscopic surgeons, working with long instruments, can apply very significant force to the tissue; unskilled movements of the operator and/or the assistant may easily cause irreversible damage to the tube. To avoid 620 Canis et al. Laparoscopic salpingostomy this damage, it is necessary to move the instruments slowly and to use a video camera to allow the operator and the assistant to work together. The ability to open the tube without any mechanical force, avoiding most of the accidental damages, is probably one of the main advantage of the C02 laser. Despite this and other potential advantages of the C02 laser, we found no difference when comparing the results obtained with the laser and conventional techniques. Our patients were not randomized, however, so a strict comparison between these techniques is not possible. Because we found no significant difference when comparing laser and electrosurgical microsurgery,23 it is likely that success rates are mainly related to tubal damages, regardless of the instrument used. Only prospective randomized studies with a large number of patients will permit demonstration of a significant difference between laser and conventional instruments. As previously noted by Daniell and Herbert, 7 the main problem when performing distal salpingostomy is obtaining adequate eversion of the tubal wall. In our experience, this difficulty was encountered with both the C02 laser and bipolar coagulation. The quality of the eversion, obtained without suture, is related to the tubal thickness; the thinner-walled tube can be easily everted, whereas the eversion of thicker-walled tube is quite impossible. This may be of little importance because the thicker-walled tubes are severely damaged and generally included in tubal stage III or IV. In such cases, the prognosis is so poor even after microsurgical eversion using sutures that IVF will likely be more successful than distal tuboplasty. In our study, 86.7% of the IUP were obtained within the 1st postoperative year, and the monthly fecundity rate decreased dramatically at the end of this period; it appears reasonable to offer IVF to any patient not pregnant 18 months after the procedure. REFERENCES 1. Gomel V: Salpingo-ovariolysis by laparoscopy in infertility. Fertil Steril 40:607, 1983 2. Bruhat MA, Mage G, Manhes H, Soualhat C, Ropert JF, Pouly JL: Laparoscopic procedure to promote fertility. Ovariolysis and salpingolysis. Results of 93 selected cases. Acta Eur Fertil 14:113, 1983 3. Nezhat C, Crowgey S, Nezhat F: Videolaseroscopy for the treatment of endometriosis associated with infertility. Fertil Steril 51:237, 1989 4. Canis M, Mage G, Manhes H, Pouly JL, Wattiez A, Bruhat MA: Laparoscopic treatment of endometriosis. Acta Obstet Gynecol Scand Suppl 150:15, 1989 5. Gomel V: Salpingostomy by laparoscopy. J Reprod Med 18: 265, 1977 Fertility and Sterility

6. Mettler L, Giesel H, Semm K: Treatment of female infertility due to tubal obstruction by operative laparoscopy. Fertil Steril 32:384, 1979 7. Daniell JF, Herbert CM: Laparoscopic salpingostomy utilizing the C0 2 laser. Fertil Steril41:558, 1984 8. Fayez JA: An assessment of the role of operative laparoscopy in tuboplasty. Fertil Steril39:476, 1983 9. Mage G, Pouly JL, Bouquet de Joliniere J, Chabrand S, Bruhat MA: Obstructions tubaires distales: microchirurgie ou fecondation in vitro. J Gynecol Obstet Biol Reprod (Paris) 13:933, 1984 10. Mage G, Pouly JL, Bouquet de Jolinieres J, Chabrand S, Riouallon A, Bruhat MA: A preoperative classification to predict the intrauterine and ectopic pregnancy rates after distal tubal microsurgery. Fertil Steril46:807, 1986 11. Mage G, Pouly JL, Canis M, Bruhat MA: C0 2 laser microsurgery: five years' experience with long-term results. Microsurgery 8:89, 1987 12. Bruhat MA, Mage G, Pouly JL, Manhes H, Canis M, Wattiez A: Coelioscopie Operatoire. Paris, Medsi McGraw-Hill Inc., 1989, p 95 13. Bruhat MA, Mage G: Use of C0 2 laser in neosalpingostomy. In Proceedings of the 3rd International Congress for Laser Surgery, Edited by I Kaplan. Tel Aviv, Jerusalem Academic Press, 1979, p 271 14. Cutler SJ, Ederer F: Maximum utilisation of life table method in analysing survival. J Chronic Dis 8:699, 1958 15. Cramer DW, Walker AM, Schiff I: Statistical methods in evaluating the outcome of infertility therapy. Fertil Steril32: 80, 1979 16. Williams TJ: Surgical procedures for inflammatory tubal disease. Obstet Gynecol Clin North Am 14:1037, 1987 17. Donnez J, Casanas-Roux F: Prognostic factors of fimbrial microsurgery. Fertil Steril 46:200, 1986 18. Ellis H: The cause and prevention of postoperative intraperitoneal adhesions. Surg Gynecol Obstet 133:497, 1971 19. Ryan GB, Groberty J, Majno G: Post operative peritoneal adhesions. Am J Pathol 65:117, 1971 20. Filmar S, Gomel V, McComb PF: Operative laparoscopy versus open abdominal surgery: a comparative study on postoperative adhesion formation in the rat model. Fertil Steril 48:486, 1987 21. Luciano AA, Maier B, Koch EI, Nulsen JC, Whitman GF: A comparative study of postoperative adhesions following laser surgery by laparoscopy versus laparotomy in the rabbit model. Obstet Gynecol 74:220, 1989 22. DeCherney AH: The leader of the band is tired. Fertil Steril 44:299, 1985 23. Mage G, Bruhat MA: Pregnancy following salpingostomy: comparison between C0 2 laser and electrosurgery procedures. Fertil Steril 40:4 72, 1983 Vol. 56, No.4, October 1991 Canis et al. Laparoscopic salpingostomy 621