OBJECTIVE

To compare surgical outcomes of laparoendoscopic single-site myomectomy (LESS-M) vs. conventional laparoscopic myomectomy (LM).

DESIGN

Multicenter, noninferiority, randomized, controlled trial.

SETTING

University hospitals.

PATIENT(S): A total of 100 subjects with symptomatic uterine myomas were randomly assigned to either LESS-M or conventional LM. Surgical outcomes were comparatively assessed between the groups on the basis of the intention-to-treat principle.

INTERVENTION(S): Laparoscopic myomectomy.

MAIN OUTCOME MEASURE(S): The time required for uterine defect suturing.

RESULT(S): There were no differences in baseline demographics (age, body mass index, surgical indication, number of myomas, and size and location of the largest myoma) between the two groups. The suturing time (mean ± SD) was 21.9 ± 10.7 minutes (95% confidence interval 18.8-24.9 min) for the LESS-M group and 23.3 ± 12.4 minutes (95% confidence interval 19.8-26.9 min) for the conventional LM group, with no significant difference between the two groups. The other surgical outcomes, such as total operative time, operative blood loss, postoperative hemoglobin change, degree of surgical difficulty, postoperative pain scores, operative complication, and length of hospital stay, were similar between the two groups. Three subjects (6%) assigned to the LESS-M group underwent conventional LM because of difficulty in myoma enucleation and suturing, whereas no failure to intended procedure occurred in the conventional LM group (6% vs. 0).

CONCLUSION(S): Laparoendoscopic single-site surgery is a feasible and safe treatment option for myomectomy that offers surgical outcomes comparable to those with conventional LM.

CLINICAL TRIAL REGISTRATION NUMBER

NCT01984632.