Vaginal vs. Laparoscopic Hysterectomy

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

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-09-30

Brief Summary

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Hysterectomy for benign indication is one of the most common surgical procedures in women. Numerous reviews and guidelines recommend the vaginal approach for benign hysterectomy, but the proportion of laparoscopic (and robotic) hysterectomies is increasing.

This study will compare a range of clinical and subjective outcomes of vaginal vs. total laparoscopic hysterectomy. Outcomes include operating time, postoperative recovery, return to work as well as cosmesis, quality of life and sexual health.

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Detailed Description

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Conditions

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Uterine Fibroids Uterine Leiomyoma Abnormal Uterine Bleeding, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vaginal hysterectomy

Group Type ACTIVE_COMPARATOR

Hysterectomy

Intervention Type PROCEDURE

Total laparoscopic hysterectomy

Laparoscopic hysterectomy

Group Type ACTIVE_COMPARATOR

Hysterectomy

Intervention Type PROCEDURE

Interventions

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Hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* benign indication for vaginal hysterectomy (e.g., abnormal uterine bleeding, fibroids, atypical endometrial hyperplasia)
* clinical exam indicates vaginal hysterectomy is feasible
* no major concomitant surgery
* able to complete questionnaires in German

Exclusion Criteria

* uterine malignancy
* major concomitant surgery (e.g., for incontinence or prolapse)
* clinical exam indicating vaginal hysterectomy not feasible
* contraindication for surgery or laparoscopy

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No