LESS-TLH Versus LESS-LAVH

NCT01861067 | Completed Phase 3

• 1 other identifier: KNC13-014
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Uterine Disease

Outcome Measures

Primary Outcomes (1)

• Operative time

  Operative time was defined as the time from skin incision to skin closure, which was electronically recorded.

  Surgery date

Study Arms (2)

LESS-TLH

EXPERIMENTAL

laparoendoscopic single-site (LESS) total laparoscopic hysterectomy (TLH)

Procedure: LESS-TLH

LESS-LAVH

ACTIVE COMPARATOR

laparoendoscopic single-site (LESS) laparoscopically-assisted vaginal hysterectomy (LAVH)

Procedure: LESS-LAVH

Interventions

LESS-TLH PROCEDURE

LESS-TLH

LESS-LAVH PROCEDURE

LESS-LAVH

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHA University: lead

Study Sites (1)

CHA Gangnam Medical Center

Seoul, 135-081, South Korea

Location

Related Publications (1)

• Song T, Kim MK, Kim ML, Jung YW, Yun BS, Seong SJ. A Randomized Comparison of Laparoendoscopic Single-Site Hysterectomies: Total Laparoscopic Hysterectomy Versus Laparoscopically Assisted Vaginal Hysterectomy. J Laparoendosc Adv Surg Tech A. 2015 Jul;25(7):541-7. doi: 10.1089/lap.2014.0524. Epub 2015 Jun 15.

  PMID: 26075931 DERIVED

Study Officials

• Taejong Song, MD PhD

  CHA Gangnam Medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 23, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

KR (1)