LESS-TLH Versus LESS-LAVH

Study Overview
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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.

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

Conditions
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Benign Uterine Disease

Intervention / Treatment
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* Procedure: LESS-TLH
* Procedure: LESS-LAVH


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LESS-TLH<br>laparoendoscopic single-site (LESS) total laparoscopic hysterectomy (TLH) | Procedure: LESS-TLH<br> <br> |
| Active Comparator: LESS-LAVH<br>laparoendoscopic single-site (LESS) laparoscopically-assisted vaginal hysterectomy (LAVH) | Procedure: LESS-LAVH<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Operative time was defined as the time from skin incision to skin closure, which was electronically recorded. | Surgery date |