The efficacy of postoperative hydrotubation: a randomized prospective multicenter clinical trial. Fertility outcome after conservative surgical treatment of ectopic pregnancy evaluated in a randomized trial. Proximal tubal occlusion and salpingectomy result in similar improvement in in vitro fertilization outcome in patients with hydrosalpinx. Failure of intraperitoneal adjuncts to improve the outcome of pelvic operations in young women. A randomised trial comparing single dose systemic methotrexate and laparoscopic surgery for the treatment of unruptured tubal pregnancy. Adhesion formation after laparoscopic surgery in tubal pregnancy: a randomized trial versus laparotomy. Method failures of laparoscopic tubal sterilization in a residency training program. A comparison of the tubal ring and spring-loaded clip. A randomized study of laparoscopic chromopertubation with lipiodol versus saline in infertile women. Comparison of a levonorgestrel-releasing intrauterine device versus expectant management after conservative surgery for symptomatic endometriosis: a pilot study.
Term pregnancies following surgery on patients with distal tubal obstruction have been disappointingly few. There has been continuing interest in whether postoperative hydrotubation increases the rate of pregnancy following salpingoneostomy and fimbrioplasty. This hypothesis was tested in a prospective, randomized, multicenter clinical trial. Patients with no infertility factors other than distal fimbrial disease were randomly assigned to either a control group (no hydrotubation, n = 86) or one of two treatment groups (hydrotubation with lactated Ringer's solution, n = 60, or lactated Ringer's solution containing hydrocortisone, n = 60). The statistical evaluation of differences among treatment groups was based on the Cox Proportional Hazards Model, which allows for covariable adjustment and for the inclusion of all patients regardless of the length of follow-up. A significant difference in the live birth rate could not be demonstrated among the groups studied (P = 0.36). The probability of a successful live birth among women treated by hydrotubation with hydrocortisone was about one-half that of the other groups (P = 0.12). Patients with moderate and severe disease had a substantially lower probability of pregnancy than those with mild disease (P = 0.013 and P = 0.0016, respectively). The probability of pregnancy increased somewhat as the number of previous pregnancies increased (P = 0.12). In this clinical trial, a beneficial effect following postoperative hydrotubation could not be demonstrated. To evaluate the fertility outcome after laparoscopic surgery for ectopic pregnancy.
                A randomized trial versus laparotomy was performed between May 1987 and June 1989.
                The study was conducted in a clinical university center, the Sahlgrens Hospital.
                A group of 105 patients with tubal pregnancy were stratified with regard to risk determinants and age and randomized to laparoscopy or laparotomy. Eighty-seven patients who desired pregnancy were evaluated for subsequent fertility outcome.
                Linear salpingotomy was performed in both surgical groups.
                We evaluated the fertility outcome after laparoscopic salpingotomy for comparison with the outcome after laparotomy.
                There was no difference between the groups in the overall fertility outcome. A substantially higher proportion of patients in the laparotomy group were subjected to adhesiolysis performed at a second-look laparoscopy.
                The fertility prospects are not impaired by laparoscopic surgery. Adhesiolysis at a second-look laparoscopy, especially after laparotomy, might be beneficial in selected cases and may serve to improve subsequent fertility. To evaluate and compare the clinical impact of proximal tubal occlusion and salpingectomy when performed before IVF in patients with hydrosalpinges.
                Prospective randomized study.
                Assisted reproduction unit in an obstetrics and gynecology department in a university hospital in Greece as well as assisted reproduction unit in an urban clinic in a major city in Greece.
                One hundred fifteen patients with unilateral or bilateral hydrosalpinges who were candidates for IVF treatment.
                Laparoscopic proximal tubal occlusion, laparoscopic salpingectomy, controlled ovarian hyperstimulation, IVF, and embryo transfer.
                Implantation rate, clinical-pregnancy rate, ongoing-pregnancy rate, abortion rate, and ectopic-pregnancy rate.
                Patients who underwent proximal tubal occlusion before IVF demonstrated significantly increased implantation, clinical-pregnancy, and ongoing-pregnancy rates compared with those with no surgical intervention and demonstrated implantation, clinical-pregnancy, and ongoing-pregnancy rates comparable to those who underwent salpingectomy.
                Proximal tubal occlusion, when performed in women with unilateral or bilateral hydrosalpinges before their IVF treatment, represents a potentially beneficial surgical procedure, increasing significantly the chances for successful implantation and for clinical and ongoing pregnancy. Proximal tubal occlusion may be viewed as a valid alternative when salpingectomy is technically difficult or not feasible. An examination was made of the possibility that 100 to 200 ml of intraperitoneal 32% dextran 70 and/or 0.5% hydrocortisone sodium succinate (randomized independently with similar volumes of Ringer's lactate solution) might help to lessen the postoperative formation of adhesions among patients undergoing surgical procedures for peritubal adhesions (n = 76), endometriosis (n = 27), or midtubal occlusion (n = 61). Patients in the first two groups who were given intraperitoneal corticosteroids were also given systemic steroids. Nonparametric comparison of median adhesion scores at operation and at subsequent laparoscopy showed that there was a poorer outcome with dextran than when dextran was not used in every subgroup except one (repeat salpingolysis after previous operation for adhesions), including first operations for adnexal adhesions (Mann-Whitney U = 200, m = 23, n = 26; p less than 0.05). The probability was small (p beta less than 0.002) that an important beneficial effect of dextran was overlooked. Systemic corticosteroids were associated with a consistent trend toward improved outcome, especially in patients who initially had few or no adhesions, such as those operated on for endometriosis (U = 2, m = 7, n = 4; p less than 0.025), but among patients with tubal resections and anastomoses with adnexal adhesions the use of intraperitoneal hydrocortisone alone was associated with a worse outcome (U = 15, m = 12, n = 8; p less than 0.02). Life-table analysis of the accumulating probability of pregnancy showed that no significant difference resulted from adjunct use in any group. The conclusion is that no empiric basis supports the use of intraperitoneal 32% dextran 70 or 0.5% hydrocortisone in the attempt to prevent peritoneal adhesions, but further investigations on the systemic administration of corticosteroids to decrease the formation of adhesions would be useful. To compare single dose systemic methotrexate (50 mg/m2) with laparoscopic surgery for the treatment of unruptured tubal pregnancy.
                An open, pragmatic, prospective randomised trial.
                Departments of obstetrics and gynaecology at three hospitals in Auckland, New Zealand.
                Clinically stable women with an unruptured tubal pregnancy diagnosed by transvaginal ultrasound and quantitative serum beta-hCG measurement. Inclusion criteria included a serum beta-hCG concentration < 5,000 IU/L, and a tubal pregnancy of < 3.5 cm diameter.
                Treatment success, physical and psychological functioning, side effects, and subsequent ipsilateral tubal patency.
                Two hundred and eighteen women with ectopic pregnancies were seen at the three hospitals. 79 women (36% eligibility rate) were eligible for trial entry and 62 women (78% recruitment rate) were recruited. Twenty-six of the 28 women (93%) randomised to laparoscopic surgery required no further treatment, compared with 22 of the 34 women (65%) randomised to methotrexate (95% CI of difference in success rate 10 - 47%; P < 0.01). Two women (7%) in the laparoscopic surgery group had persistent trophoblast. Nine women (26%) in the methotrexate group required more than one dose of methotrexate and five women (15%) underwent laparoscopy during follow up. In the laparoscopy group three women (11%) had negative laparoscopies and two women (7%) had were found to have a ruptured fallopian tube at the time of surgery. Women treated with methotrexate had significantly better objective physical functioning scores but there were no differences in any other psychological outcomes. Women treated with methotrexate experienced greater and more prolonged vaginal bleeding. The likelihood of methotrexate treatment failure was greater at higher serum beta-hCG concentrations. Ipsilateral tubal patency rates were similar in each group.
                This trial shows that in the treatment of tubal pregnancy single dose systemic methotrexate is a less effective treatment than laparoscopic salpingotomy. It is well tolerated, but should only be offered as an alternative to surgery to women who have mild symptoms and present at low serum beta-hCG concentrations. In our population this likely to be no more than a quarter of women presenting with a tubal pregnancy. Women with ectopic pregnancy (EP) who have been operated on by laparoscopy are thought to have improved subsequent fertility, probably because of less adhesion formation. We aimed to evaluate the adhesion formation after laparoscopy as compared with laparotomy in a randomized trial.
                One hundred five patients with tubal pregnancy were stratified with regard to age and risk factors and randomized to surgery by laparoscopy or laparotomy. To evaluate adhesion formation and tubal status, 73 patients with strong desire of pregnancy underwent a second-look laparoscopy. The adhesion status at the ipsilateral and contralateral side at primary surgery was compared with the status at second-look laparoscopy.
                Patients operated on by laparotomy developed significantly more adhesions at the operated side than patients operated on by laparoscopy (P less than 0.001). Substantially more patients in the laparotomy group underwent adhesiolysis at second-look laparoscopy than did patients in the laparoscopy group. Tubal patency did not differ between the groups.
                Laparoscopic treatment of EP results in less impairment of the pelvic status compared with conventional conservative surgery. A prospective, randomized study of 365 women undergoing interval laparoscopic tubal sterilization in a residency training program was undertaken to compare method failures. Two occlusive techniques were compared, the spring-loaded clip (Hulka-Clemens) and the tubal ring (Falope Ring). Patients were randomized to either Falope Rings or Hulka-Clemens clips as the primary method. Demographic characteristics, educational level and operator experience were similar in the two groups. Follow-up at an average of 16 months (range, 6-24) revealed eight pregnancies (4.5%) in 176 women in the clip group and five pregnancies (2.6%) in the ring group. The Hulka-Clemens clip and the Falope Ring have similar incidences of method failure when employed by inexperienced operators. We question the usefulness of chromopertubation utilizing methylene blue dye to ensure proper placement of the occlusive device. Eighty-eight infertile patients undergoing laparoscopy were randomized to undergo chromopertubation with lipiodol or with normal saline. The cumulative probability of conception at 1, 3, and 6 months following laparoscopy was not statistically different between the lipiodol group (21%, 31% , and 43%, respectively) and the saline group (18%, 21%, and 33%, respectively). To determine whether the frequency and severity of dysmenorrhea are reduced in women with symptomatic endometriosis in whom a levonorgestrel-releasing intrauterine device (Lng-IUD) is inserted after operative laparoscopy compared with those treated with surgery only.
                Open-label, parallel-group, randomized, controlled trial.
                A tertiary care and referral center for patients with endometriosis.
                Parous women with moderate or severe dysmenorrhea undergoing first-line operative laparoscopy for symptomatic endometriosis.
                Randomization to immediate Lng-IUD insertion or expectant management after laparoscopic treatment of endometriotic lesions. Proportions of women with recurrence of moderate or severe dysmenorrhea in the two study groups 1 year after surgery and overall degree of satisfaction with treatment. Moderate or severe dysmenorrhea recurred in 2 of 20 (10%) subjects in the postoperative Lng-IUD group and 9/20 (45%) in the surgery-only group. Thus, a medicated device inserted postoperatively will prevent the recurrence of moderate or severe dysmenorrhea in one out of three patients 1 year after surgery. A total of 15/20 (75%) women in the Lng-IUD group and 10/20 (50%) in the expectant management group were satisfied or very satisfied with the treatment received.
                Insertion of an Lng-IUD after laparoscopic surgery for symptomatic endometriosis significantly reduced the medium-term risk of recurrence of moderate or severe dysmenorrhea.
There is insufficient evidence to support the routine practice of hydrotubation or second-look laparoscopy following female pelvic reproductive surgery. The studies on which this conclusion is based were either of poor quality or underpowered. These interventions should be performed in the context of a good quality, adequately powered randomised controlled trial. Postoperative hydrotubation with fluid containing antibiotic may offer benefit over hydrotubation fluid without antibiotic following tubal surgery. A randomised controlled trial of postoperative hydrotubation with antibiotic-containing fluid versus no hydrotubation for improving fertility following tubal surgery is justified.