LESS-TLH Versus LESS-LAVH

Benign Uterine Disease Clinical Trial

Official title:

A Randomized Comparison of Laparoendoscopic Single-site (LESS) Hysterectomies: Total Laparoscopic Hysterectomy (TLH) Versus Laparoscopically Assisted Vaginal Hysterectomy (LAVH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861067
• Other study ID #: KNC13-014
• Status: Completed
• Phase: Phase 3
• First received: May 21, 2013
• Last updated: April 15, 2015
• Start date: April 2013
• Est. completion date: January 2014

Study information

• Verified date: April 2015
• Source: CHA University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Uterine Disease
• Uterine Diseases

Intervention

Procedure:
• LESS-TLH

• LESS-LAVH

Locations

Country	Name	City	State
Korea, Republic of	CHA Gangnam Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CHA University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Operative time was defined as the time from skin incision to skin closure, which was electronically recorded.	Surgery date	No