A randomised trial comparing single dose systemic methotrexate and laparoscopic surgery for the treatment of unruptured tubal pregnancy. Randomised trial of systemic methotrexate versus laparoscopic salpingostomy in tubal pregnancy. Prostaglandin versus expectant management in early tubal pregnancy. Laparoscopic salpingostomy versus laparoscopic local methotrexate injection in the management of unruptured ectopic gestation. Randomized trial of conservative laparoscopic treatment and methotrexate administration in ectopic pregnancy and subsequent fertility. Fertility outcome after conservative surgical treatment of ectopic pregnancy evaluated in a randomized trial. Systemic methotrexate therapy versus laparoscopic salpingostomy in patients with tubal pregnancy. Part I. Impact on patients' health-related quality of life. Conservative management of ectopic pregnancy: prospective randomized clinical trial of methotrexate versus prostaglandin sulprostone by combined transvaginal and systemic administration. Laparoscopic surgery in ectopic pregnancy. A randomized trial versus laparotomy. Ultrasound-guided injection of methotrexate versus laparoscopic salpingotomy in ectopic pregnancy. Local injection of methotrexate dissolved in saline versus methotrexate suspensions for the conservative treatment of ectopic pregnancy. [Clinical study of tubal pregnancy treated with integrated traditional Chinese and Western medicine]. An economic evaluation of single dose systemic methotrexate and laparoscopic surgery for the treatment of unruptured ectopic pregnancy. A cost-effectiveness study of a randomised trial of laparoscopy versus laparotomy for ectopic pregnancy. Low-dose oral methotrexate with expectant management of ectopic pregnancy. Mifepristone in combination with methotrexate for the medical treatment of tubal pregnancy: a randomized, controlled trial. Methotrexate versus hyperosomolar glucose in the treatment of extrauterine pregnancy. A randomized controlled comparison of minialpartomy and lapartomy in ectopic pregnancy cases. Intramesosalpingeal injection of oxytocin in conservative laparoscopic treatment for tubal pregnancy: preliminary results. Transvaginal intra-amniotic injection of methotrexate in early ectopic pregnancy. Advantages over the laparoscopic approach. Proximal tubal occlusion and salpingectomy result in similar improvement in in vitro fertilization outcome in patients with hydrosalpinx. Fertility outcome after systemic methotrexate and laparoscopic salpingostomy for tubal pregnancy. Laparoscopic salpingotomy for tubal pregnancy: comparison of linear salpingotomy with and without suturing. Prophylactic vasopressin during laparoscopic salpingotomy for ectopic pregnancy. Resolution of hormonal markers of ectopic gestation: a randomized trial comparing single-dose intramuscular methotrexate with salpingostomy. Early intrauterine pregnancy failure: a randomized trial of medical versus surgical treatment. Management of unruptured ectopic gestation by linear salpingostomy: a prospective, randomized clinical trial of laparoscopy versus laparotomy. Conservative treatment of ectopic pregnancy with local injection of hyperosmolar glucose solution or prostaglandin-F2 alpha: a prospective randomised study. Treatment of ectopic pregnancy by local injection of hypertonic glucose: a randomized trial comparing administration guided by transvaginal ultrasound or laparoscopy. A randomized study comparing efficacy and patient satisfaction in medical or surgical treatment of miscarriage. Medical management of non-viable early first trimester pregnancy. Adhesion formation after laparoscopic surgery in tubal pregnancy: a randomized trial versus laparotomy. Methotrexate prophylaxis for persistent ectopic pregnancy after conservative treatment by salpingostomy. Reproductive outcome after linear salpingostomy for ectopic gestation: a prospective 3-year follow-up. Randomized clinical trial of two laparoscopic treatments of endometriomas: cystectomy versus drainage and coagulation. Lack of resolution of ectopic pregnancy by intratubal injection of methotrexate. Comparison of laparoscopic sterilization via spring-loaded clip and tubal ring.
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. Laparoscopic salpingostomy is a well-established treatment for patients with tubal pregnancy who desire to retain fertility. Another approach that preserves the fallopian tube is medical treatment. We compared systemic methotrexate and laparoscopic salpingostomy in the treatment of tubal pregnancy. Outcome measures were treatment success, tubal preservation, and homolateral tubal patency.
                Between January, 1994, and September, 1996, haemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy and no signs of active bleeding were randomly assigned systemic methotrexate (four 1.0 mg/kg doses of intramuscular methotrexate alternated with 0.1 mg/kg oral folinic acid) or laparoscopic salpingostomy. Treatment success was defined as complete elimination of the tubal pregnancy (serum human chorionic gonadotropin < 2 IU/L) and preservation of the tube. Homolateral tubal patency was assessed by hysterosalpingography. Analysis was by intention to treat.
                100 patients were included in the trial. Of 51 patients allocated systemic methotrexate, 42 (82%) were successfully treated with one course; two (4%) patients needed a second course for persistent trophoblast. Surgical intervention was needed in seven (14%) patients; salpingectomy was necessary in five of these patients for tubal rupture. Of the 49 patients allocated laparoscopic salpingostomy, 35 (72%) were successfully treated by laparoscopic salpingostomy alone; salpingectomy was needed in four (8%) patients, and ten (20%) needed methotrexate for persistent trophoblast. The tube was preserved in 46 (90%) patients in the methotrexate group versus 45 (92%) in the salpingostomy group (rate ratio 0.98 [95% CI 0.87-1.1]). Homolateral tubal patency could be assessed in 81 patients: the tube was patent in 23 (55%) of 42 patients in the methotrexate group and in 23 (59%) of 39 patients in the salpingostomy group (rate ratio 0.93 [0.64-1.4]).
                In haemodynamically stable patients with unruptured tubal pregnancy, systemic methotrexate and laparoscopic salpingostomy were successful in treating the majority of cases. We found no significant difference between the treatments in the homolateral patency rate. Subsequent fertility outcome has to be awaited to show which treatment yields better fertility prospects. Since ectopic pregnancy may terminate in spontaneous recovery we compared treatment by means of prostaglandin (PG) application with expectant management in laparoscopically verified tubal gestations. Twelve patients received local and systemic PG, 4 patients were treated with sodium chloride and in 7 patients laparoscopy was discontinued without medical therapy. The comparison between the PG group and the placebo groups revealed a highly significant difference with regard to a subsequent necessary surgical intervention and hospitalisation. Expectant management may only be recommended in very selected cases, whereas PG treatment seems to produce favourable results in cases of early tubal pregnancy. Our goal was to determine whether laparoscopic salpingostomy is preferable to laparoscopic methotrexate injection in the management of unruptured tubal gestation.
                Forty-eight patients with unruptured tubal pregnancy were prospectively randomized to either laparoscopic salpingostomy or laparoscopic local methotrexate injection in a university medical center. Operation time, duration of hospital stay, decrease in levels of beta-human chorionic gonadotropin, and fertility outcome were compared between the two groups.
                The salpingostomy group had a longer operative time (p < 0.0001) but a shorter hospital stay (p < 0.01) and a lower incidence of persistent trophoblastic activity (5% vs 14%), although this difference did not reach statistical significance. The time interval until beta-human chorionic gonadotropin disappearance was similar (13.9 and 13.7 days), and the subsequent intrauterine pregnancy rate was similar in the two groups (83.5% and 81%). One repeat tubal pregnancy occurred in the salpingostomy group.
                Both these methods of conservative management are equally effective and each one has its merits. Methotrexate treatment was compared to laparoscopic salpingotomy for conservative management of ectopic pregnancy in a prospective randomized study. One hundred patients were randomized into two groups using random numbers. Inclusion criteria were an ectopic pregnancy visualized by ultrasound with a pre-therapeutic score <13 as assessed by the following six criteria, graded from 1 to 3: gestational age, human chorionic gonadotrophin (HCG) concentration, progesterone concentration, abdominal pain, haemoperitoneal volume and diameter of the haematosalpinx. The treatments were either 1 mg/kg of methotrexate injected transvaginally into the ectopic pregnancy without anaesthesia or administered i.m. when the pregnancy could not safely or easily be punctured (group 1), or laparoscopic salpingotomy (group 2). Success was defined as the return to normal (<10 mIU/ml) of HCG concentrations. Treatment was successful for 45 of 51 patients in group 1 (88.2%) and 47 of 49 in group 2 (95.9%). Medical treatment was significantly (P < 0.05) associated with shorter postoperative stay (24 compared with 46 h), but HCG returned to normal more quickly after laparoscopic treatment (13 compared with 29 days). Spontaneous reproductive performance was similar in both groups, but overall intrauterine pregnancy was higher, and repeat ectopic pregnancy lower, after methotrexate treatment. In selected cases of ectopic pregnancy, with a pre-therapeutic score <13, methotrexate treatment appeared as safe and efficient as conservative treatment by laparoscopy and was associated with improved subsequent fertility. 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 compare patients' health-related quality of life after systemic methotrexate therapy versus laparoscopic salpingostomy for tubal pregnancy.
                Multicenter randomized clinical trial.
                Departments of obstetrics and gynecology of six Dutch hospitals.
                Hemodynamically stable patients with a laparoscopically confirmed unruptured tubal pregnancy without signs of active bleeding, who were randomly assigned to undergo either systemic methotrexate therapy or laparoscopic salpingostomy.
                Standard health-related quality of life questionnaires administered before and 2 days, 2 weeks, 4 weeks. and 16 weeks after confirmative laparoscopy.
                Health-related quality of life.
                Health-related quality of life was impaired most severely 2 days after confirmative laparoscopy in both treatment groups and improved during follow-up. Health-related quality of life was impaired more severely after systemic methotrexate therapy than after laparoscopic salpingostomy. Medically treated patients had more limitations in physical functioning, role functioning, and social functioning; had worse health perceptions, less energy, more pain, more physical symptoms, and a worse overall quality of life; and were more depressed than surgically treated patients.
                Systemic methotrexate therapy had a more negative impact on patients' health-related quality of life than did laparoscopic salpingostomy. This negative impact on patients' health-related quality of life of systemic methotrexate therapy should be taken into account when deciding on the appropriate therapy for tubal pregnancy. In a prospective randomized study, 21 patients with an unruptured tubal pregnancy were treated with local and systemic injection. On the day of diagnosis, methotrexate (MTX) (1 mg/kg) or sulprostone (500 micrograms) were injected into the gestational sac under transvaginal sonographic control. The systemic component consisted of an intramuscular injection of MTX (1 mg/kg) 3, 5, and 7 days after local injection or of sulprostone (500 micrograms) on the 1st 2 postlocal injection days. Methotrexate therapy was successful in 8 of 12 patients and sulprostone therapy in 6 of 9. Laparoscopy was then performed on the 7 unsuccessful patients: 3 of them had pain and hemoperitoneum and 4 of them had rising human choriogonadotropin (hCG) levels. One stomatitis after MTX and one cramping abdominal pain were observed. Thirteen of 14 successfully treated patients had initial hCG levels less than 5,000 mIU/mL. At subsequent hysterosalpinography, 13 of 14 patients had normal tubal configuration and patency. Three of 10 patients who desired another pregnancy had already achieved a normal intrauterine pregnancy. These results suggest that MTX and sulprostone were equally effective, and medical approach for the unruptured ectopic pregnancy may be restricted to patients with hCG less than 5,000 mIU/mL. A randomized, prospective clinical trial was conducted to compare the efficacy of laparoscopic treatment with conventional conservative abdominal surgery for tubal pregnancy. Entry criteria were: size of the ectopic gestation less than 4 cm, hemodynamic stability, accessibility for laparoscopic treatment and a trained laparoscopist on duty. There was no difference between the groups regarding gestational duration, size and location of the ectopic gestation, or the mean preoperative hCG values. The groups differed with respect to total operation time (73 min for the laparoscopy group vs. 88 min for the laparotomy group), hospital stay (2.2 vs. 5.4 days) and convalescence period (11 vs. 24 days). The rates of elimination of hCG was similar in the groups, and there were no statistical difference in the rate of second intervention. To compare local injection of methotrexate (MTX) under sonographic control to laparoscopic salpingotomy for conservative management of ectopic pregnancy (EP).
                Prospective randomized study.
                Forty patients were randomized into two groups using a random number table. Inclusion criteria were an EP visualized by ultrasound with a pretherapeutic score < or = 13 as assessed by six criteria graded from 1 to 3: gestational age, hCG level, P level, abdominal pain, volume of the hemoperitoneum, and diameter of the hematosalpinx.
                Group 1 patients injected transvaginally with 1 mg/kg MTX into the EP without anesthesia versus group 2 patients undergoing laparoscopic salpingotomy.
                Postoperative hospital stay, decrease of hCG levels, success rate.
                The success rates, defined by hCG levels returned to normal (< 10 mIU/mL [conversion factor to SI units, 1.00]), were 19 of 20 in both groups. Medical treatment was associated significantly with shorter postoperative stay (24 versus 46 hours) and a higher initial hCG level. Human chorionic gonadotropin returned to normal more quickly after laparoscopic treatment (14 versus 28 days).
                In selected cases of EP with a pretherapeutic score < or = 13, MTX treatment appeared to be as safe and efficient as was conservative treatment by laparoscopy. To compare the local injection of methotrexate (MTX) dissolved in saline and MTX suspensions for the laparoscopic treatment of ectopic pregnancy in terms of success rate and postoperative tubal patency. A total of 26 patients with unruptured ectopic pregnancies were selected from among 60 women with ectopic pregnancies admitted to the Nagasaki University clinic. Of these patients, 12 were treated with MTX dissolved in saline solution (solution group) and 14 with MTX suspensions consisting of lipiodol (LPD) with phosphatidylcholine (PC) added as a dispersing stabilizer (suspension group). Except for one case treated under transvaginal guidance, all the patients were treated by laparoscopy. Persistent ectopic pregnancy was recognized in seven cases (58%) in the solution group but in only two cases (14%) in the suspension group. Moreover, rupture occurred in two cases in the solution group but in no case in the suspension group. A patent treated tube was found in seven of 10 cases in the saline group and in 10 of 12 cases in the suspension group. During the follow-up period of 6-31 months, five women in the saline group and three women in the suspension group had an intrauterine pregnancy. In this study, the local injection of MTX is considered to be a reasonable method for the treatment of unruptured ectopic pregnancy, and the MTX suspension seems to be more effective and useful than MTX solution. To explore the therapeutic effect and the mechanism of tubal pregnancy (TP) treated with integrated traditional Chinese and Western medicine (TCM-WM).
                Seventy-eight patients suffering from TP were divided into two groups at random, 50 cases of treated group treated with the method of integrated Methotrexate (MTX) and Ectopic Pregnancy 2 (EP2) decoction, and the other 28 cases treated with MTX alone for control.
                The nonsurgical method cure rate of the treated group (98.0%) was higher than that of the control group (75.0%, P < 0.01). The intrauterine pregnancy rate of the treated group was 80.0%, that of the control group was 42.9% (P < 0.01). The recurrent TP rate of the treated group (4.0%) was lower than that of the control group (14.2%, P < 0.01). The serum beta-HCG normalizing time of the treated group (25.0 +/- 7.8 days) was shorter than that of the control group (31.9 +/- 6.7 days, P < 0.05). The total disappearance time of TP mass was 1.2 +/- 0.7 months in the treated group, and in the control group was 5.6 +/- 3.7 months (P < 0.01). After treated by EP2 decoction for 4-8 weeks, the deformability of erythrocyte was increased, the aggregation of erythrocyte, the whole blood viscosity and the blood plasma viscosity were reduced.
                The integrated method can effectively increase nonsurgical cure rate, tubal patency rate and intrauterine pregnancy rate, decrease recurrent TP rate in treating TP. To compare the direct and indirect costs of single dose systemic methotrexate with laparoscopic surgery for the treatment of unruptured ectopic pregnancy.
                A cost minimisation study undertaken alongside a randomised trial.
                Departments of Obstetrics and Gynaecology in three hospitals in Auckland, New Zealand.
                Sixty-two women with an ectopic pregnancy randomised to treatment with either a single dose of methotrexate (50 mg/m2) or laparoscopic surgery.
                Direct and indirect costs based on the results of the randomised trial.
                Direct costs per case were significantly lower in the methotrexate group (mean $NZ 1,470) than in the laparoscopy group (mean $NZ 3,083) with a mean difference of $NZ 1,613 (95% CI $NZ 1,166 - $NZ 2,061). These significant differences existed under a wide range of alternative assumptions about unit costs. The difference in direct costs in favour of methotrexate was greatest for women presenting with low pretreatment serum beta-hCG concentrations. Mean indirect costs were also significantly lower in the methotrexate group (mean $NZ 1,141) than in the laparoscopy group (mean $NZ 1899) with a mean difference of $NZ 758 (95% CI $NZ 277 - $NZ 1,240). For women presenting with pretreatment serum beta-hCG concentrations of over 1,500 IU/ L this difference in indirect costs is lost due to the prolonged follow up required and a higher rate of surgical intervention in women receiving methotrexate.
                This economic evaluation shows that treating suitable women with an ectopic pregnancy using systemic methotrexate therapy results in a significant reduction in direct costs. The indirect costs borne by the woman and her carers are only likely to be reduced in women with pretreatment serum beta-hCG concentrations under 1,500 IU/L. We compared the cost-effectiveness of therapeutic laparoscopy and open laparotomy for treatment of laparoscopically diagnosed ectopic pregnancy. Clinical outcomes of ectopic pregnancy treatment were based on results of a randomised trial done between 1987 and 1989 at Sahlgrenska University Hospital (Göteborg, Sweden). We estimated costs for inpatient and follow-up care of ectopic pregnancy by the two methods. Observed resource use (eg, procedure duration) was multiplied by 1992 estimates of resource unit cost (eg, cost per minute of laparoscopy time), based on detailed internal cost accounting data from Huddinge University Hospital. By specified criteria, the initial procedure eliminated trophoblastic activity without major complications in 81% (95% CI: 68-90) of 52 laparoscopy patients, versus 95% (85-99) of 57 laparotomy patients. Residual trophoblast or complications were successfully treated in all remaining patients. Mean simulated costs (standard error) for the overall laparoscopy strategy were 28,058 (1780) Swedish kronor versus 32,699 (1080) kronor for laparotomy (p = 0.03). In the baseline simulation and most sensitivity analyses, laparoscopy produced final outcomes equivalent to those of laparotomy at lower costs. As laparoscopic outcomes improve, this newer approach should become increasingly preferable. To investigate recovery times and need for laparoscopy in women with ectopic pregnancy who were treated for 5 days 2.5 mg/day of oral methotrexate or placebo.
                Sixty women with ectopic pregnancy among patients of an outpatient clinic specializing in early pregnancy disorders were selected for medical treatment in a double-blind, placebo-controlled study. The diagnosis was made by transvaginal sonography and serum hCG determinations, either at admission or after repeated examinations. Women were recruited for the study if they had mild symptoms: the hCG increase was less than 50% within 2 days, the diameter of the ectopic pregnancy was less than 40 mm, there were no signs of intra-abdominal bleeding by transvaginal sonography, and there were no secondary reasons for laparoscopy. Either 2.5 mg of methotrexate or placebo was given orally for 5 days. Serum hCG was determined after 2 days, and hCG, red blood cell count, white blood cell count, platelet count, and serum glutamic-oxaloacetic transaminase were measured; transvaginal sonography was performed after 5 and 12 days. Expectant management was continued individually with check-ups at 1-3-week intervals. Laparoscopy was performed if the patient developed abdominal pain or intra-abdominal hemorrhage, as seen by transvaginal sonography. Statistical analysis was by paired or unpaired t test, Mann-Whitney U test, regression analysis, and repeated measures analysis of variance.
                Seventy-seven percent of the patients recovered without the need for laparoscopy in both groups, and there were no significant differences in recovery times or the need for laparoscopy between groups.
                Oral methotrexate, 2.5 mg for 5 days, does not appear to be more effective than placebo in the treatment of ectopic pregnancy in women eligible for expectant management. In the search for a more potent alternative to a single i.m. injection of methotrexate for ectopic pregnancy, a randomized trial was organized. The efficacy of a combination of methotrexate and mifepristone was compared with methotrexate alone in the treatment of unruptured tubal pregnancies. The diagnosis of an unruptured tubal pregnancy was confirmed laparoscopically in 50 patients during a 2 year period. Women were randomized to receive a single i.m. injection of 50 mg/m2 methotrexate alone or a single dose of 600 mg oral mifepristone in combination with the same dose of methotrexate. Both treatment protocols were successful in achieving the resolution of unruptured ectopic pregnancy (18/25 in the methotrexate group and 22/25 in the combination group) following the initial intervention. A second injection was needed in four (16%) cases in the methotrexate group and in one (4%) case in the combination group. Overall, a complete resolution was achieved in 22/25 and 23/25 cases respectively. Unruptured ectopic pregnancy resolved faster in women given the combination of methotrexate and mifepristone compared to women given methotrexate only (P = 0.01). The effect of the methotrexate and mifepristone combination was more pronounced in women with higher human chorionic gonadotrophin concentrations. The aim of this prospective, randomized, double blind study was to compare the efficacy of methotrexate and hyperosmolar glucose injected directly into the extra-uterine gestational sac under laparoscopic vision. The study included twenty women with ectopic pregnancy. Inclusion criteria were intact tubal pregnancy, not exceeding 4 cm in diameter, rising or plateauing betahCG levels, and no evidence of intra-abdominal bleeding. The patients were treated by laparoscopically guided injection of 3 mL fluid into the area containing the tubal pregnancy. The fluid contained either 25 mg methotrexate (n=9) or 50% glucose (n=9). Daily decrease in betahCG levels was faster in patients treated by methotrexate (median 8.7%) than in those treated by hyperosmolar glucose (median 4.8%), p=0.17. The study was discontinued due to a higher failure rate in the group treated by hyperosmolar glucose. In conclusion, local injection of methotrexate is superior to hyperosmolar glucose. It can be used as an alternative to salpingostomy or salpingotomy whenever laparoscopy is performed for the diagnosis and treatment of extra-uterine pregnancy. As ectopic pregnancy is associated with significant maternal mortality and morbidity it may be worthwhile to find alternative surgical method to traditional laparotomy.
                To compare the efficacy, safety and cost effectiveness of minilaparotomy surgery for ectopic pregnancy cases with standard laparotomy method.
                A total of 60 patients of ectopic pregnancy were randomized for minilaparotomy and laparotomy (30 cases each) for three years from January. 1998 to March 2001 in a medical college hospital.
                Patients history, clinical examination, intraoperative, preoperative and postoperative data were recorded and compared in minilaparotomy and laparotomy groups.
                Chi-square and Fischer chi-square test is used using P value of less than 0.05 as level of significance.
                Mean operative time was significantly less in minilaparotomy (38 minutes) than in laparotomy group (54 minutes). Postoperative complications were fever in 4(13.33%) and 6(20%) cases, paralytic ileus in 3(10%) and 8(26.66%) cases, urinary tract infection in 2(6.66%) and 3(10%) cases and wound infection in 1(3.33%) and 5(16.66%) cases respectively in the two groups and were significantly less in the minilaparotomy cases. Mean day of mobility, starting normal diet and discharge from the hospital were 10 hours and 24 hours, 1.5 days and 3.1 days and 3.4 days and 6.9 days respectively in the two groups and were significantly less in the minilaparotomy group than the laparotomy group.
                Surgery by minilaparotomy technique in ectopic pregnancy cases appears to be a safe and feasible method and is superior to conventional laparotomy as there are minimum perioperative and postoperative complications and patients can be discharged early from the hospital without the need of expensive equipment. The objective of this study was to evaluate the efficacy of the local use of oxytocin as adjuvant treatment in conservative surgery for tubal pregnancy. The patients were 25 women with laparoscopic diagnosis of tubal pregnancy who were candidates for salpingotomy. Before salpingotomy, each patient was randomly allocated to intramesosalpingeal injection of 20 IU oxytocin diluted to 20 ml with saline solution or 20 ml saline solution. The surgeon then proceeded with salpingotomy and removal of the pregnancy according to the usual technique. The main outcome measures were bleeding during salpingotomy, ease of removal of the pregnancy, bleeding at the site of the pregnancy, and need for recourse to salpingectomy. Twelve women were randomized to the oxytocin group and 13 to the control group. Examination of the surgeons' assessments of the difficulties encountered at the different stages of surgery revealed statistically significant differences between the oxytocin group and controls in each variable. In particular, the amount of endosalpingeal bleeding after removal of the pregnancy was less in the oxytocin group. In one control patient, persistent bleeding due to incomplete trophoblast removal forced the surgeon to perform salpingectomy. Our results indicate that intramesosalpingeal injection of oxytocin facilitates the performance of conservative laparoscopic treatment for tubal pregnancy. Methotrexate (MTX, 100 mg) was administered to 36 patients with early ectopic pregnancy locally, either under laparoscopic control into the distended fallopian tube (group A, n = 16), or transvaginally into the gestational sac directly, under ultrasound guidance (group B, n = 20). In cases with persistent beta-hCG levels (n = 7), an additional 50 mg of MTX solution was instilled into the affected tube, following transuterine tubal catheterization. Comparing the two different routes of MTX administration, it was shown that the resolution time (beta-hCG < 20 mIU/ml) in group B was significantly shorter (2.4 +/- 1.1 weeks vs. 4.1 +/- 1.9 weeks in group A, P < 0.05), with a better success rate (100% and 88%, respectively). Serum MTX levels were found within a low range and no systemic side effects were noticed. In conclusion, direct intraovular MTX injection under ultrasound guidance proved superior to the laparoscopically-controlled 'blind' intratubal injection. A relatively high dose of MTX (100 mg) seems justified in order to shorten the resolution period, especially in cases with high initial beta-hCG levels and/or fetal heart motion present. 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. nan The study was carried out to clarify the incidence of post-operative tubal adhesions, patency rate and pregnancy outcome after laparoscopic salpingotomy with and without suturing for tubal pregnancy.
                From May 1996 to December 2002, a total of 97 cases of tubal pregnancy were treated in our centre by laparoscopic conservative surgery. The successful salpingotomy cases were randomly assigned to undergo salpingotomy without suturing (group I; n = 43) or with suturing (group II; n = 32). We compared these patients and assessed their surgical and pregnancy outcome by second look laparoscopy (SLL) 3 months after the first operation.
                Seventy-five cases (77%) were treated successfully by salpingotomy at initial laparoscopic surgery, and the remaining 22 cases were unsuccessful because of bleeding or complete tubal damage. Pelvic findings were assessed at SLL in 21 of 43 cases (49%) in group I and 17 of 32 (53%) in group II. There were no significant differences in gestational age, ectopic site, tubal diameter, tubal condition, intraperitoneal haemorrhage and pre-operative HCG levels between the two groups. Only the operation time was longer in group II than in group I (91 +/- 15 versus 69 +/- 15 min, P < 0.05). The tubal patency rate of the treated side was 90% (19/21) in group I and 94% (16/17) in group II. Also the peritubal adhesions were observed in 33% (7/21) in group I and 29% (5/17) in group II, and were mostly comprised of filmy adhesions. A tubal fistula occurred in two cases in each group. Pregnancy rate was 79% (15/19) in group I and 92% (12/13) in group II, and this did not reveal any significant difference of cumulative pregnancy rate between the groups.
                We recommend laparoscopic linear salpingotomy as a useful method in the management of cases with tubal pregnancy who desire future pregnancy. This preliminary study emphasizes that the procedure involving suturing has no additional benefit over the non-suturing technique during salpingotomy. To evaluate the safety and efficacy of prophylactic mesosalpingeal vasopressin injection for hemostasis during laparoscopic salpingotomy for ectopic pregnancy.
                Prospective, randomized clinical study.
                Reproductive endocrinology and endoscopic surgery clinic of a tertiary care hospital.
                Forty women with ectopic pregnancy.
                Laparoscopic linear salpingotomy was attempted, with prophylactic mesosalpingeal dilute vasopressin injection in 20 patients (study group), and without vasopressin in 20 patients (control group). The two groups were similar with regard to age, size of ectopic pregnancy, gestational age, and initial beta-hCG values. A multipuncture operative laparoscopy technique was used in all cases and bipolar electrocoagulation was used for hemostasis.
                The operating time was significantly shorter and the need for electrocoagulation was significantly less in the study than in the control group (p <0.05). Laparoscopic salpingotomy was performed successfully in 85% of study group patients compared with 70% of controls (p >0.05). Postoperative hysterogram revealed patency of the affected tube in 76.5% of women in the study group compared with 57.1% of controls (p >0.05). Possible complications of vasopressin, such as hypertension, bradycardia, and delayed bleeding, did not occur in any patient.
                Vasopressin use reduces both operating time and the need for electrocoagulation for hemostasis, which can have undesirable effects on the tube. Vasopressin was not associated with side effects in this relatively small sample. To evaluate resolution of serum hCG and progesterone in patients with ectopic pregnancy receiving single-dose intramuscular (IM) methotrexate as compared with those undergoing laparoscopic salpingostomy.
                In this prospective randomized clinical trial, 75 hemodynamically stable women with a diagnosis of ectopic pregnancy were randomized to treatment with single-dose IM methotrexate (1 mg/kg) or laparoscopic salpingostomy. All women had initial, day 4, and weekly serum hCG and progesterone measurements taken until hCG levels were less than 15 mIU/mL. Methotrexate therapy was repeated if posttreatment day 7 hCG levels did not decrease by 15%, as compared with day 4 levels. Success rate was defined as ectopic resolution without the need for the alternate mode of therapy.
                Thirty-eight women were randomized to treatment with methotrexate and 37 to laparoscopic salpingostomy. The mean (+/-standard deviation) time required for serum progesterone concentrations to decrease to less than 1.5 ng/mL was significantly less for laparoscopic salpingostomy than for treatment with methotrexate: 7.8+/-1.7 and 17.6+/-2.2 days, respectively (P < .01). Within each treatment group, serum progesterone levels resolved (less than 1.5 ng/mL) more rapidly than did hCG levels (less than 15 mIU/mL) (P < .01). No further treatment was required once serum progesterone levels had decreased to less than 1.5 ng/mL. Success rates were similar in both groups: 94.7% (36 of 38) for methotrexate and 91.4% (33 of 36) for laparoscopic salpingostomy. Mean time required for hCG concentrations to decrease to less than 15 mIU/mL was significantly less for laparoscopic salpingostomy than for methotrexate therapy: 20.2+/-2.7 and 27.2+/-2.3 days, respectively (P < .05). Additional methotrexate injections were required in 15.8% (6 of 38) of women randomized to methotrexate therapy. Initial serum hCG levels for patients receiving additional methotrexate doses were 4830+/-1588 mIU/mL as compared with 2133+/-393 mIU/mL for women receiving only one dose (P = .07).
                Serum progesterone levels of less than 1.5 ng/mL are a good predictor of ectopic pregnancy resolution regardless of treatment, and because its return to normal values occurs more rapidly than that of hCG levels, serum progesterone may be a better marker for predicting successful treatment. Although laparoscopic salpingostomy leads to faster resolution of hormonal markers of ectopic gestation, methotrexate is equally successful for treating small unruptured ectopic pregnancies. Initial hCG levels may be a marker for women requiring additional doses of methotrexate. The purpose of this study was to determine whether medical treatment of early pregnancy failure represents a reasonable alternative to surgical therapy.
                Patients who were diagnosed with pregnancy failure before 12 weeks of gestation were randomly assigned to receive either medical (intravaginal misoprostol) or surgical therapy (dilatation and curettage). In the medical arm of the study, 800 microg of misoprostol was placed within the posterior vaginal fornix. Patients subsequently were seen 24 and 48 hours after the initial dosing; intravaginal misoprostol was readministered only if ultrasound images revealed evidence of persistent pregnancy tissue. By 72 hours after initial study entry, if either a gestational sac or placental tissue was present, the medical treatment was considered a failure, and uterine curettage was performed. Statistical analysis was performed with the two-tailed unpaired t test, chi(2) analysis, Fisher exact test, and Mann-Whitney U test; a probability value of <.05 was considered statistically significant.
                A total of 50 women were enrolled, with 2 patients in the surgical arm experiencing spontaneous pregnancy loss before their scheduled procedures. Twenty-five women received medical therapy; 25 women were randomized to surgical procedure. Fifteen patients in the medical group (60%; 95% CI, 0.41-0.79) had successful pregnancy termination and did not require curettage. There were no significant differences between the medical and surgical groups with respect to either posttreatment hematocrit level or the time needed to achieve negative human chorionic gonadotropin test results.
                Intravaginal misoprostol is an effective agent for the treatment of early pregnancy failure. Medical treatment of early pregnancy failure represents a reasonable alternative to immediate surgical therapy. This study was designed to compare prospectively the parameters of morbidity, cost, length of hospital stay, and fertility outcome after linear salpingostomy by laparoscopy versus laparotomy. Entry criteria included stable vital signs, hematocrit greater than 30%, age over 18 years, and desire for future fertility. All patients underwent diagnostic laparoscopy. Sixty patients with unruptured ectopic gestations of 5 cm or smaller were randomized to either laparoscopy (N = 30) or laparotomy (N = 30). Postoperative follow-up included serial measurements of serum beta-hCG titers at 3-day intervals and hysterosalpingography at 12 weeks. The laparoscopy and laparotomy groups were similar in age, height, weight, gravidity, gestational age, hematocrit, ectopic pregnancy size, and preoperative beta-hCG levels. The estimated blood loss was significantly (P less than .001) lower in patients undergoing laparoscopy, and was not affected by vasopressin injection. Two patients in the laparoscopy group required laparotomy for hemostasis, and two patients undergoing laparotomy had wound infection. One patient in each group had persistent trophoblastic activity. Baseline serum beta-hCG levels and the rate and magnitude of postoperative beta-hCG decline were similar in both groups. The length of hospital stay was significantly (P less than .001) shorter after laparoscopic salpingostomy (1.4 +/- 0.1 days) than after laparotomy (3.3 +/- 0.2 days). Postoperative hysterosalpingography showed patency of the involved tube in 16 of 20 (80%) and 17 of 19 (89%) of patients in the laparoscopy and laparotomy groups, respectively. Pregnancy rates were ten of 18 (56%) and 11 of 19 (58%) in these groups, respectively, and all pregnancies were conceived within 6 months of surgery.(ABSTRACT TRUNCATED AT 250 WORDS) In a prospective randomised study, 31 patients with an unruptured tubal pregnancy were treated either with local and systemic prostaglandins or with local instillation of a hyperosmolar glucose solution. Prostaglandin therapy was successful in 13 of 15 patients and glucose therapy in 16 of 16. 9 women treated with prostaglandins had cramping abdominal pains postoperatively. No side-effects were noted in those treated with glucose. At subsequent hysterosalpingography 5 of 6 patients treated with prostaglandins and 7 of 8 treated with glucose had normal tubal configuration and patency. 3 patients treated with glucose later had a normal intrauterine pregnancy, demonstrably through the affected tube in 1 case. These results suggest that local instillation of hyperosmolar glucose solution is an option in the laparoscopic management of unruptured tubal pregnancies. To study local treatment of ectopic pregnancy by injection of hyperosmolar (50%) glucose, guided either by transvaginal ultrasound or by laparoscopy.
                Eighty women were randomized, 39 into the sonography and 41 into the laparoscopy group. Criteria for inclusion were 1) ectopic pregnancy < or = 4 cm seen by transvaginal ultrasound, 2) hCG < or = 3000 IU/l, and 3) little or no intraabdominal bleeding. In the sonography group, patients were treated by one skilled ultrasound investigator, whereas injections by laparoscopy were performed by several colleagues. The former group were offered a second glucose injection if hCG levels were rising. Those successfully treated were offered hysterosalpingography (HSG) for evaluation of tubal patency.
                Twenty-nine (74.4%) women were successfully treated in the sonography group by one single injection, compared to 21 (51.2%) in the laparoscopy group. Eight women in the sonography group received a second glucose injection because of a rising hCG, increasing the success rate in this group to 82.1% (32 of 39 women). Six patients in the laparoscopy group were not injected due to technical difficulties during the operation, and the success rate for those injected were 60% (21 of 35 women). The overall success rate was 66.3%. Of the 28 women investigated by HSG, both tubes were normal in 19 (67.8%), and in 25 patients (89.3%) the treated tube was open.
                Local injection of hyperosmolar glucose guided by transvaginal ultrasound by one skilled investigator is an effective treatment for ectopic pregnancy. Most women preserve tubal patency after treatment. To compare the efficacy of the medical treatment to surgical uterine evacuation and patient satisfaction in each group.
                A randomized, controlled study.
                An outpatient clinic in the Department of Gynecology and Obstetrics in Oulu University Hospital, Oulu, Finland.
                Ninety-eight eligible women who had had miscarriages.
                Medical treatment of miscarriage (n = 49) with 200 mg of mifepristone and 0.8 mg of misoprostol 1-3 days after the event or surgical uterine evacuation (n = 49). Questionnaires to collect data of experienced pain and patient satisfaction.
                The complete abortion rate with the primary treatment (primary outcome) and the patient satisfaction (secondary outcome).
                The success rate was equal (100% in surgical and 90% in medical group). More infections were diagnosed in the surgical group. Surgically treated patients were more satisfied with the treatment (100% vs. 88%). Medical treatment was considered more painful and fewer patients (70% vs. 91%) would choose the medical method in the future.
                Medical treatment is an effective alternative to surgical treatment and increases the choice available to women. Surgical treatment is associated with more infections. More medically treated patients experienced pain and dissatisfaction. To compare the efficacy of intramuscular methotrexate plus vaginal misoprostol to vaginal misoprostol alone in completing abortion in women with non-viable early first trimester pregnancy.
                Twenty-one women with non-viable pregnancy up to 49 days gestation were randomized to receive intramuscular methotrexate, followed 2 days later by vaginal misoprostol or misoprostol alone. We also collected patient satisfaction information.
                Complete abortion occurred in all 12 (100%) women in the combined group and eight of nine (89%, RR = 1.13, CI 0.89-1.42) women in the misoprostol only group. Of the women, 75% rated their experience as good and would choose medical management again.
                Either methotrexate plus misoprostol or misoprostol alone effectively completed abortion in women with non-viable early pregnancy and represent acceptable medical alternatives to surgery or expectant management. 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. To investigate whether the incidence of persistent ectopic pregnancy after linear salpingostomy can be reduced by prophylactic administration of a single dose of methotrexate postoperatively.
                Women who underwent linear salpingostomy for treatment of unruptured ectopic pregnancy and who agreed to participate in the study (n = 129) were randomly assigned to the prophylaxis or control group. Women with anemia, renal insufficiency, or liver disease were excluded. In the prophylaxis group, patients received a single dose of methotrexate, 1 mg/kg intramuscularly, within 24 hours postoperatively. No treatment was used in the control group. Both groups were followed with serial serum beta-hCG titers; titers were measured on the seventh postoperative day, then every 72 hours until levels were lower than 15 mIU/mL. A blood count and chemistry panel were also obtained on postoperative day 7, and any side effects related to methotrexate were noted. Persistent ectopic pregnancy was defined as a rise in the serum beta-hCG level or a decline of less than 20% between two consecutive measurements taken 3 days apart.
                A total of 116 women completed the postoperative follow-up: 54 in the prophylaxis group and 62 in the control group. Ten women had persistent ectopic pregnancy, one in the prophylaxis group (1.9%) and nine among the controls (14.5%); this difference was statistically significant (P < .05). The relative risk of developing persistent ectopic pregnancy after prophylactic methotrexate was 0.13 (95% confidence interval 0.02, 0.97). Three women (5.5%) reported mild side effects after methotrexate, but these resolved spontaneously.
                The incidence of persistent ectopic pregnancy was significantly reduced after a single prophylactic dose of systemic methotrexate administered postoperatively. This regimen is safe and can be used to decrease the extent of postoperative monitoring after conservative treatment of unruptured ectopic pregnancy. The long-term reproductive outcome in patients treated with linear salpingostomy for ectopic gestation was similarly impacted by laparoscopy and laparotomy, further establishing laparoscopic salpingostomy as the preferable treatment modality. Patients with two consecutive ectopic gestations may not benefit from the conservative surgical approach because it may predispose them to a high risk of recurrence. To assess the efficacy of two laparoscopic methods for the management of endometriomas with regard to pain relief, pregnancy rate, and disease recurrence.
                Prospective, randomized clinical trial.
                Tertiary care hospital.
                Sixty-four patients with advanced stages of endometriosis.
                Patients were randomly allocated at the time of laparoscopy to undergo either cystectomy of the endometrioma (group 1) or drainage of the endometrioma and bipolar coagulation of the inner lining (group 2).
                Pain relief and pregnancy rate.
                Thirty-two patients were enrolled in each group. The 24-month cumulative recurrence rates of dysmenorrhea, deep dyspareunia, and nonmenstrual pelvic pain were lower in group 1 than in group 2 (dysmenorrhea: 15.8% versus 52.9%; deep dyspareunia: 20% versus 75%; nonmenstrual pelvic pain: 10% versus 52.9%). The median interval between the operation and the recurrence of moderate to severe pelvic pain was longer in group 1 than in group 2 (19 months [range, 13.5-24 months] versus 9.5 months [range, 3-20 months]). The 24-month cumulative pregnancy rate was higher in group 1 than in group 2 (66.7% versus 23.5%).
                For the treatment of ovarian endometriomas, a better outcome with a similar rate of complications is achieved with laparoscopic cystectomy than with drainage and coagulation. Although reports of local injection of MTX in the treatment of EP appeared to be promising, our results do not confirm the efficacy of this approach. Our experience was sufficiently discouraging to prompt discontinuation of a randomized trail; our hope is that others will add to the accumulating data base so that the role of local injection of MTX can be clarified. The spring-loaded clip and tubal ring techniques of laparoscopic female sterilization were compared for ease of performance, safety and effectiveness at the Asociación Demográfica Salvadoreña in San Salvador, where they were randomly assigned to a total of 299 patients. Rates of technical/equipment difficulties and procedural difficulties during laparoscopy were similar for both techniques. Procedure-related surgical complications occurred in three ring patients as a result of tubal transection. Pain during the procedure was more severe for tubal ring patients. Results suggest that both techniques can be safely and effectively used for laparoscopic sterilization.
In the surgical treatment of tubal ectopic pregnancy laparoscopic surgery is a cost effective treatment. An alternative non surgical treatment option in selected patients is medical treatment with systemic methotrexate. Expectant management can not be adequately evaluated yet.