A Randomized Trial of Laparoscopic Versus Laparoscopic-Assisted Minilaparotomy Myomectomy for Removal of Large Uterine Myoma: Short-Term Outcomes
Received 25 February 2008; accepted 21 March 2008.
Abstract
Study Objective
To compare operative data and early postoperative outcomes for myomectomy performed by isobaric gasless laparoscopic-assisted minilaparotomy (LA-MLT) compared with those by isobaric gasless laparoscopy (LA) in a series of patients with large uterine leiomyomas (≥5 cm) randomly assigned to each surgical technique.
Design
Randomized trial (Canadian Task Force classification I).
Setting
University departments of gynecology in Jiangyin and Nanjing, Jiangsu Province, Republic of China.
Patients
Fifty-two patients were randomized blindly by use of a computer randomization list to either LA (n = 26) or LA-MLT (n = 26).
Measurements and Main Results
The mean operating time was significantly shorter after LA-MLT than after LA (75.50 ± 25.70 vs 96.00 ± 26.20 minutes); the 95% confidence interval (95% CI) was 20.5 (6.04–34.96; p =.006). The intraoperative blood loss was less with LA-MLT (71.92 ± 18.98 vs 96.34 ± 32.42 mL); the 95% CI was 24.42 (9.63–39.22; p =.002); and the hemoglobin level decrease was less with LA-MLT (1.22 ± 0.61 vs 1.65 ± 0.61); the 95% CI was 0.43 (0.09–0.76; p =.014). There was a difference of the visual analog scale score among the 3 time points (0, 12, and 24 hours) with the 2 groups combined (F = 844.15, p <.001); and no difference in the visual analog scale score between the treatment groups, with values at all time points averaged and over time (p >.05). With regard to the early postoperative outcome, no difference between the 2 groups was detected in hospitalization days (1.81 ± 0.57 vs 2.04 ± 0.66 days; 95% CI 20.23 [20.57–0.11, p =.183]); and postoperative ileus (23.20 ± 4.37 vs 22.80 ± 3.94; 95% CI 0.39 [21.93–2.70, p =.738]).
Conclusions
Several surgical and immediate postoperative outcomes were significantly better in the gasless LA-MLT group than in the LA group.
aDepartment of Gynaecology, Jiangyin Hospital, Medical School of Southeast of China University, Jiangyin City
bDepartment of Gynaecology, Jiangsu People Hospital, Nanjing Medical University, Nanjing City
cSchool of Public Health, Peking University, Beijing, Republic of China
Corresponding author: Daoyuan Wang, Department of Gynaecology, Jiangyin Hospital, Medical school of Southeast of China University, No. 35 East of Renming Road, Jiangyin City, Jiangsu Province 214400, PR China.
The authors have no commercial, proprietary, or financial interest in the products or companies described in this article.
ABSTRACT