LESS-TLH Versus LESS-LAVH

Phase 3

Completed

• Conditions: Benign Uterine Disease
• Interventions: Procedure: LESS-LAVH; Procedure: LESS-TLH

• Registration Number: NCT01861067
• Lead Sponsor: CHA University

Brief Summary

During the last 2 decades, several studies have tried to define the best surgical approach to hysterectomy for benign uterine diseases1. Accumulating evidence demonstrates that abdominal hysterectomy has a higher incidence of complications, a longer hospital stay and a slower convalescence in comparison with laparoscopic hysterectomy (LH). The main advantage of LHs is the absence of a wide abdominal scar, which results in fewer wound-related complications and in a significant decrease of postoperative pain.

Technologic advances in endoscopic instrumentation and optics have allowed the development of an even less invasive procedure than conventional LH using multiple ports: laparoendoscopic single-site (LESS) surgery, also known as single-port access (SPA) laparoscopy3. In the LESS approaches, total laparoscopic hysterectomy (TLH) and laparoscopically-assisted vaginal hysterectomy (LAVH) are all feasible, with comparable conventional LH. However, it is yet to be determined which of two alternative and less invasive approaches (LESS-TLH and LESS-LAVH) should be preferred. In particular, none has focused on postoperative pain as the primary outcome of the study. The investigators have therefore designed the randomized trial to investigate specifically differences in postoperative pain after LESS-TLH and LESS-LAVH.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-23
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

• women with indication for hysterectomy for a supposed benign uterine disease
• women with an age of 18 years or older
• women who were not pregnant at the time of presentation
• women who were appropriated medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)

Exclusion Criteria

• uterine volume > 18 weeks of gestation by pelvic examination
• suspicion of malignancy
• pelvic organ prolapse > stage 1 according to POP-Q classification
• inability to understand and provide written informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LESS-LAVH	LESS-LAVH	laparoendoscopic single-site (LESS) laparoscopically-assisted vaginal hysterectomy (LAVH)
LESS-TLH	LESS-TLH	laparoendoscopic single-site (LESS) total laparoscopic hysterectomy (TLH)

Primary Outcome Measures

Name	Time	Method
Operative time	Surgery date	Operative time was defined as the time from skin incision to skin closure, which was electronically recorded.

Trial Locations

Locations (1)

CHA Gangnam Medical Center; 🇰🇷 Seoul, Korea, Republic of