Comparison of single-site and three-port hysterectomy for benign uterine diseases: A randomised trial (LESS-H)

Abstract

Objective

To evaluate the feasibility and safety of laparoendoscopic single-site (LESS) vaginal hysterectomy compared to conventional three-port laparoscopic-assisted vaginal hysterectomy (LAVH) for benign and pre-invasive uterine disease.

Methods

We conducted a prospective randomized controlled trial that included patients who were scheduled to undergo hysterectomy using laparoscopic surgery for the benign and pre-invasive uterine diseases. The primary endpoint was to compare the ratio of patients discharged within 2 days after surgery between LESS LAVH and three-port LAVH groups.

Results

A total of 428 patients were randomised to the LESS group (n = 216) and the conventional group (n = 212). The two groups did not show significant differences in the proportion of patients discharged within two days after surgery (LESS vs. three-port, 93 % vs. 90 %, P = 0.277). There were also no significant differences in operating time, hemoglobin change, average length of postoperative hospital stay and perioperative complications. While the visual analogue score (VAS) pain score during hospital stay was similar between the two groups, the pain score at the first outpatient visit (2 weeks after surgery) was significantly lower in the LESS group (LESS vs. three-port, 3.29 vs. 3.93, P = 0.012).

Conclusions

Although LESS LAVH was not superior to conventional multiport surgery, it is a feasible, safe procedure for managing benign and pre-invasive uterine diseases.

Trial registration

Clinicaltrial.gov identifier number: NCT01679548, https://clinicaltrials.gov/study/NCT01679548.