LESS-TLH Versus LESS-LAVH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Benign Uterine Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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LESS-TLH

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

Group Type EXPERIMENTAL

LESS-TLH

Intervention Type PROCEDURE

LESS-LAVH

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

Group Type ACTIVE_COMPARATOR

LESS-LAVH

Intervention Type PROCEDURE

Interventions

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LESS-TLH

Intervention Type PROCEDURE

LESS-LAVH

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No