Vaginal vs. Laparoscopic Hysterectomy

April 16, 2018 updated by: Medical University of Graz

Vaginal Hysterectomy Versus Total Laparoscopic Hysterectomy for Benign Indications: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8020
        • Krankenhaus der Barmherzigen Brüder, Abteilung Gynäkologie
      • Graz, Austria, 8036
        • Medical University of Graz/Dept. OB/GYN
      • Leoben, Austria, 8700
        • LKH Leoben/Abteilung Gynäkologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vaginal hysterectomy
Procedure: Hysterectomy
Active Comparator: Total laparoscopic hysterectomy
Laparoscopic hysterectomy
Procedure: Hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating time (min.)
Time Frame: Surgery
Operating time (min.)
Surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 12 months
12 months
Complications
Time Frame: 6 weeks
Intraoperative and postoperative complications
6 weeks
Anesthesia time (min.)
Time Frame: surgery
surgery
Sexual health
Time Frame: 12 months
12 months
Return to work
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

Austrian Urogynecology Working Group (AUWG)

Investigators

  • Study Chair: Karl F Tamussino, MD, Medical University of Graz
  • Principal Investigator: Rene W Laky, MD, Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 10, 2014

First Posted (Estimate)

February 11, 2014

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-122 ex 13/14
  • MUG 26-122 ex 13/14 (Other Identifier: MUGraz)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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