Micro-laparoscopic Versus Single-port Total Hysterectomy: a Randomized Trial.

Between May 2011 and February 2012 a prospective randomized study was carried out at the Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome-Italy.

Consenting patients scheduled to be submitted to a total laparoscopic hysterectomy for benign, pre-malignant and malignant disease were evaluated for this study. Inclusion criteria for total laparoscopic hysterectomy were: appropriate medical status for laparoscopic surgery; uterine size < 12 weeks of pregnancy; no previous longitudinal major abdominal surgery. Patients who had a pelvic organ prolapse greater than grade I, were excluded from this study.

Pre-operative work-up included gynecologic examination, trans-vaginal ultrasound. In case of early endometrial and cervical cancer a staging MRI or CT was performed.

Our institutional review board approved the study (Protocol number P/473/CE/2011), and all women gave their informed consent to use their data. All patients were adequately informed concerning the possible risks and benefits of the described technique and signed a written consent agreeing to undergo the procedure and to eventual conversion to LPS or laparotomy, if necessary.

Patients were randomly assigned to either a hysterectomy with LESS or with M-LPS. The surgeon was notified of the allocation in theater on the morning of the procedure. The same surgical team performed both techniques. Assignment to one of the two surgical approaches was on 1:1, using a block randomized computer-generated list.