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 (> or =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.