Laparoendoscopic single-site myomectomy compared with conventional laparoscopic myomectomy: a multicenter, randomized, controlled trial.
OBJECTIVE
To compare surgical outcomes of laparoendoscopic single-site myomectomy (LESS-M) vs. conventional laparoscopic myomectomy (LM).


METHODS
Multicenter, noninferiority, randomized, controlled trial.


METHODS
University hospitals.


METHODS
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.


METHODS
Laparoscopic myomectomy.


METHODS
The time required for uterine defect suturing.


RESULTS
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).


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


BACKGROUND
NCT01984632.
Department of Obstetrics and Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Republic of Korea.
Taejong
T
Song
Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Tae-Joong
TJ
Kim
Department of Obstetrics and Gynecology, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea.
San-Hui
SH
Lee
Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Tae-Hyun
TH
Kim
Department of Obstetrics and Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: obgykim@gmail.com.
Woo-Young
WY
Kim
D000328:Adult; D016063:Blood Loss, Surgical; D005240:Feasibility Studies; D005260:Female; D006785:Hospitals, University; D006801:Humans; D057194:Intention to Treat Analysis; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods*; D007889:Leiomyoma / Q000473:pathology / Q000601:surgery*; D007902:Length of Stay; D008875:Middle Aged; D061646:Operative Time; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D056910:Republic of Korea; D013536:Suture Techniques; D013997:Time Factors; D016896:Treatment Outcome; D063186:Uterine Myomectomy / Q000009:adverse effects / Q000379:methods*; D014594:Uterine Neoplasms / Q000473:pathology / Q000601:surgery*
Laparoendoscopic single-site surgery; laparoscopic myomectomy; myoma; myomectomy