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Clinical Trials/NCT01861067
NCT01861067CompletedPhase 3

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

CHA University2 sites in 1 country76 target enrollmentStarted: April 2013Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
76
Locations
2
Primary Endpoint
Operative time

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Operative time

Time Frame: Surgery date

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Taejong Song

Professor

CHA University

Study Sites (2)

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