OBJECTIVE: Our purpose was to compare the results of laparoscopy with laparotomy in the management of ovarian masses not suspected to be malignant. STUDY DESIGN: 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. RESULTS: 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. CONCLUSION:Operative laparoscopy should replace laparotomy in the management of benign ovarian masses.
RCT Entities:
OBJECTIVE: Our purpose was to compare the results of laparoscopy with laparotomy in the management of ovarian masses not suspected to be malignant. STUDY DESIGN: 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. RESULTS: 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. CONCLUSION: Operative laparoscopy should replace laparotomy in the management of benign ovarian masses.