Fertility and obstetric outcome after laparoscopic myomectomy of large myomata: a randomized comparison with abdominal myomectomy. A multicenter randomized, controlled study comparing laparoscopic versus minilaparotomic myomectomy: reproductive outcomes. Fertility outcome after conservative surgical treatment of ectopic pregnancy evaluated in a randomized trial. Quality of life and surgical outcome after total laparoscopic hysterectomy versus total abdominal hysterectomy for benign disease: a randomized, controlled trial. The psychosocial outcomes of total and subtotal hysterectomy: A randomized controlled trial. A randomized prospective study of laparoscopy and laparotomy in the management of benign ovarian masses. Safety of laparoscopy versus laparotomy in early-stage endometrial cancer: a randomised trial. [Laparoscopic versus conventional appendectomy: a prospective randomized study]. Value of laparoscopic assistance for vaginal hysterectomy with prophylactic bilateral oophorectomy.
The purpose of this study was to compare, in infertile patients, the efficacy of laparoscopic myomectomy versus abdominal myomectomy, in restoring fertility and to evaluate the obstetric outcomes. Between January 1993 and January 1998, 131 patients of reproductive age, with anamnesis of infertility, underwent myomectomy because of the presence of at least one large myoma (diameter greater than or = 5 cm). Patients were randomly selected for treatment by laparotomy (n = 65) or laparoscopy (n = 66). The two groups were homogeneous for number, size and position of large myomata. Significant differences were found in the post-operative outcome: febrile morbidity (> 38 degrees C) was more frequent in the abdominal than in the laparoscopic group (26.2 versus 12.1%; P < 0.05). Laparotomy caused a more pronounced haemoglobin drop (2.17 +/- 1.57 versus 1.33 +/- 1.23; P < 0.001); three patients received a blood transfusion after laparotomy and none after laparoscopy. The post-operative hospital stay was shorter in the laparoscopic group (142.80 +/- 34.60 versus 75.61 +/- 37.09 h; P < 0.001). No significant differences were found between the two groups as concerns pregnancy rate (55.9% after laparotomy, 53.6% after laparoscopy), abortion rate (12.1 versus 20%), preterm delivery (7.4 versus 5%) and the use of Caesarean section (77.8 versus 65%). No case of uterine rupture during pregnancy or labour was observed. To assess the reproductive outcomes after minilaparotomic and laparoscopic myomectomy in patients wishing to conceive.
                Randomized controlled trial.
                Departments of obstetrics and gynecology of the universities of Catanzaro, Rome, and Florence, Italy.
                One hundred thirty-six women with symptomatic uterine leiomyomas or unexplained infertility.
                Laparoscopic and minilaparotomic myomectomy.
                Pregnancy, abortion, and live-birth rates.
                Between the laparoscopic and minilaparotomic groups no difference was observed in cumulative pregnancy, live-birth, and abortion rates, whereas pregnancy and live-birth rates per cycle, and time to first pregnancy and live-birth were significantly higher in the laparoscopic than in the minilaparotomic group. Categorizing the patients according to surgical indication for myomectomy, cumulative pregnancy rate, pregnancy, and live-birth rates per cycle, and time to first pregnancy and live-birth were significantly better after laparoscopic myomectomy in symptomatic patients, whereas all reproductive outcomes were similar between the two groups in patients with unexplained infertility.
                Minilaparotomic and laparoscopic myomectomy improves in a similar manner the reproductive outcomes in patients with unexplained infertility, whereas the laparoscopic approach provides the best benefits in fertile patients with symptomatic leiomyomas. 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. Minimally invasive surgery aims to achieve at least a similar clinical effectiveness with a quicker recovery than traditional open techniques. Although there have been numerous randomized clinical trials comparing laparoscopic hysterectomy with hysterectomy by laparotomy, only a few studies have compared quality of life after different types of hysterectomy. None of these studies evaluated total laparoscopic hysterectomy. In this paper, we report on a randomized comparison of quality of life after total laparoscopic versus total abdominal hysterectomy.
                Randomized, controlled trial (Canadian Task Force classification I).
                Single-center teaching hospital in The Netherlands.
                Patients scheduled for hysterectomy for a benign condition, in whom a vaginal hysterectomy was not possible and laparoscopic hysterectomy was feasible (mobile uterus not exceeding the size of 18 weeks' gestation).
                Abdominal versus laparoscopic hysterectomy.
                Patients completed the Dutch version RAND-36 health survey preoperatively as well as at 5 time points in the first 12 weeks after surgery. The primary outcome of the study was quality of life as measured by the RAND-36. A linear mixed model was used for statistical analysis while accounting for baseline values. Secondary outcomes were hospital stay and complications. There were 88 patients eligible, of whom 59 gave consent for randomization. Twenty-seven women were allocated to the laparoscopic arm and 32 to the abdominal arm. We found a significant treatment effect favoring laparoscopic hysterectomy in the RAND-36 scale for vitality. Laparoscopic hysterectomy performed better on all other scales of the RAND-36, but these differences were not statistically significant.
                Laparoscopic hysterectomy results in more postoperative vitality when compared with abdominal hysterectomy. For this reason, all women with a benign condition requiring abdominal hysterectomy, in whom the laparoscopic approach is feasible, should have the chance to choose laparoscopic hysterectomy. Current controversies involve the adverse effects of hysterectomy on women's psychosocial functioning and whether subtotal as opposed to total hysterectomy mitigates these effects.
                To investigate the psychosocial effects of hysterectomy by examining sexual, pain, and psychological outcomes of total vs. subtotal hysterectomy in a randomized controlled trial.
                Patients suffering from benign gynecological conditions were randomly assigned to one of two groups: (i) total hysterectomy, that is, laparoscopic assisted vaginal hysterectomy (TOT, N = 32); or (ii) subtotal hysterectomy, that is, supracervical laparoscopic hysterectomy (SUB, N = 31). Both groups were premenopausal and underwent hysterectomy without concurrent oophorectomy. Two premenopausal control groups: (i) minor gynecological surgery (SURG-CON, N = 30); and (ii) healthy nonsurgical controls (NORM-CON, N = 40), were also tested. All surgical groups were assessed 2-3 weeks before surgery and then 6-7 months afterward; the nonsurgical control group was assessed at the time of recruitment and 6-7 months later.
                Assessments included semistructured interviews, standardized questionnaires, and standardized gynecological examinations.
                For the TOT group, sexual drive, arousal, and sexual behavior significantly improved postoperatively. For the SUB group, sexual behavior and overall sexual functioning significantly improved. For both TOT and SUB groups, unprovoked pain in the abdomen and pain in the abdomen during gynecological examinations was significantly reduced. For both TOT and SUB groups, overall psychological functioning did not significantly change postoperatively. Although between 3% and 16% of women undergoing hysterectomy reported adverse changes in psychosocial well-being after surgery, similar percentages of women in the control groups reported such effects.
                Hysterectomy resulted in a consistent reduction in abdominal pain, some improvement in sexual functioning, but no change in overall psychological functioning. There was no evidence supporting the idea that subtotal hysterectomy produced more favorable psychosocial outcomes than total hysterectomy nor was there any evidence that either type of hysterectomy resulted in adverse effects. Our purpose was to compare the results of laparoscopy with laparotomy in the management of ovarian masses not suspected to be malignant.
                In a prospective randomized study 102 patients requiring surgical management of ovarian masses were randomly assigned to laparoscopy (52) or laparotomy (50) in a teaching hospital from July 1994 to September 1995. Inclusion criteria was tumor not suspected to be malignant with a diameter of < or = 10 cm as measured by ultrasonography. All operations were performed by trainees under the supervision of an experienced surgeon. Statistical analysis included t tests and chi2 tests.
                There were no differences in demographic characteristics between the two groups nor any difference in the size of ovarian masses, adnexal adhesion score, or frequency of bilateral disease. All the ovarian masses were benign. Endometriotic cysts and dermoid cysts were the most common disorder in the two groups. Cystectomy was performed in > 70% of cases in each group. Operating time was not increased with the laparoscopic approach, and the frequency of inadvertent rupture of the ovarian masses was just as high as in laparotomy. The laparoscopic approach was associated with a significant reduction in operative morbidity (odds ratio 0.34, 95% confidence interval 0.13 to 0.88), postoperative pain and analgesic requirement, hospital stay, and recovery period. Patients in general were satisfied with the operation, but significantly more patients were satisfied with the laparoscopy scar.
                Operative laparoscopy should replace laparotomy in the management of benign ovarian masses. The standard surgery for early-stage endometrial cancer is total abdominal hysterectomy (TAH) and bilateral salpingo-oophorectomy, which is associated with substantial morbidity. Total laparoscopic hysterectomy (TLH) and bilateral salpingo-oophorectomy is less invasive and is assumed to be associated with lower morbidity, particularly in obese women. This study investigated the complication rate of TLH versus TAH in women with early-stage endometrial cancer.
                This randomised trial was done in 21 hospitals in The Netherlands, and 26 gynaecologists with proven sufficient skills in TLH participated. 283 patients with stage I endometrioid adenocarcinoma or complex atypical hyperplasia were randomly allocated (2:1) to the intervention group (TLH, n=187) or control group (TAH, n=96). Randomisation by sequential number generation was done centrally in alternate blocks of six and three participants, with stratification by trial centre. After assignment, the study coordinators, patients, gynaecologists, and members of the panel were not masked to intervention. The primary outcome was major complication rate, assessed by an independent panel. Data were analysed by a modified intention-to-treat analysis, since two patients in both groups were excluded from the main analysis. This trial is registered with the Dutch trial registry, number NTR821.
                The proportion of major complications was 14.6% (27 of 185) in the TLH group versus 14.9% (14 of 94) in the TAH group, with a difference of -0.3% (95% CI -9.1 to 8.5; p=0.95). The proportion of patients with an intraoperative major complication (nine of 279 [3.2%]) was lower than the proportion with a postoperative major complication (32 of 279 [11.5%]) and did not differ between TLH (five of 185 [2.7%]) and TAH (four of 94 [4.3%]; p=0.49). The proportion of patients with a minor complication was 13.0% (24 of 185) in the TLH group and 11.7% (11 of 94) in the TAH group (p=0.76). Conversion to laparotomy occurred in 10.8% (20 of 185) of the laparoscopic procedures. TLH was associated with significantly less blood loss (p<0.0001), less use of pain medication (p<0.0001), a shorter hospital stay (p<0.0001), and a faster recovery (p=0.002), but the procedure took longer than TAH (p<0.0001).
                Our results showed no evidence of a benefit for TLH over TAH in terms of major complications, but TLH (done by skilled surgeons) was beneficial in terms of a shorter hospital stay, less pain, and quicker resumption of daily activities.
                The Dutch Organization for Health Research and Development (ZonMw), programme efficacy.
                2010 Elsevier Ltd. All rights reserved. The discussion about laparoscopic appendectomy has increased since the introduction of this method. Randomized comparisons are still feasible, whereas this cannot be stated for other laparoscopic procedures (e.g., laparoscopic cholecystectomy). This randomized controlled trial included 170 patients. Open appendectomy was employed in 83 patients, and 87 were treated laparoscopically. The treatment groups were comparable regarding age, sex, Broca index, ASA classification, preliminary operations, and preoperative leucocytes. No statistically significant differences could be found with respect to surgical and general complications, operating time, consumption of analgesics and antibiotics, and return to work. The analysis revealed a statistically significant shorter hospital stay, a shorter time until return to normal physical activity, and a shorter duration of complaints for the laparoscopic group. We were unable to demonstrate any statistically significant advantage in using the open procedure. This study was undertaken to compare morbidity for women undergoing laparoscopy-assisted vaginal hysterectomy with bilateral oophorectomy (LAVHO) and vaginal hysterectomy with bilateral oophorectomy without laparoscopic assistance (VHO).
                Between April 1, 2002, and February 1, 2004, a prospective randomized study at Marseille University Hospital (La Conception) included 48 patients who underwent a hysterectomy with prophylactic bilateral oophorectomy for benign uterine conditions. These patients were allocated to 2 groups (LAVHO vs VHO). The study variables were duration of surgery and of hospitalization and surgical and postoperative complications.
                There was no significant difference in the duration of surgery between the LAVHO and VHO groups (100.2 +/- 27.9 vs 83.9 +/- 34.6, P = .08). The rate of complications was significantly higher in the LAVHO group (13/24 [54.1%] vs 6/24 [25%], P = .039).
                The overall complication rate was higher with LAVHO than VHO. It thus appears that laparoscopic assistance is not useful in performing vaginal hysterectomies with prophylactic bilateral oophorectomies in patients without other related disorders (endometriosis, adhesions, adnexal anomalies).
There is currently insufficient evidence from randomised controlled trials to evaluate the role of myomectomy to improve fertility. Regarding the surgical approach to myomectomy, current evidence from two randomised controlled trials suggests there is no significant difference between the laparoscopic and open approach regarding fertility performance. This evidence needs to be viewed with caution due to the small number of studies. Finally, there is currently no evidence from randomised controlled trials regarding the effect of hysteroscopic myomectomy on fertility outcomes.