A Randomized Trial of Laparoscopic Versus Laparoscopic-Assisted Minilaparotomy Myomectomy for Removal of Large Uterine Myoma: Short-Term Outcomes

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.

Key words: Isobaric gasless laparoscopy, Minilaparotomy, Laparoscopic-assisted minilaparotomy, Myomectomy