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Vaginal vs. Laparoscopic Hysterectomy

Primary Purpose

Uterine Fibroids, Uterine Leiomyoma, Abnormal Uterine Bleeding, Unspecified

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Hysterectomy
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring Hysterectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vaginal hysterectomy

Total laparoscopic hysterectomy

Arm Description

Vaginal hysterectomy

Laparoscopic hysterectomy

Outcomes

Primary Outcome Measures

Operating time (min.)
Operating time (min.)

Secondary Outcome Measures

Complications
Intraoperative and postoperative complications
Anesthesia time (min.)
Quality of life
Sexual health
Return to work

Full Information

First Posted
February 10, 2014
Last Updated
April 16, 2018
Sponsor
Medical University of Graz
Collaborators
Austrian Urogynecology Working Group (AUWG)
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1. Study Identification

Unique Protocol Identification Number
NCT02059954
Brief Title
Vaginal vs. Laparoscopic Hysterectomy
Official Title
Vaginal Hysterectomy Versus Total Laparoscopic Hysterectomy for Benign Indications: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
Collaborators
Austrian Urogynecology Working Group (AUWG)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Uterine Leiomyoma, Abnormal Uterine Bleeding, Unspecified
Keywords
Hysterectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaginal hysterectomy
Arm Type
Active Comparator
Arm Description
Vaginal hysterectomy
Arm Title
Total laparoscopic hysterectomy
Arm Type
Active Comparator
Arm Description
Laparoscopic hysterectomy
Intervention Type
Procedure
Intervention Name(s)
Hysterectomy
Primary Outcome Measure Information:
Title
Operating time (min.)
Description
Operating time (min.)
Time Frame
Surgery
Secondary Outcome Measure Information:
Title
Complications
Description
Intraoperative and postoperative complications
Time Frame
6 weeks
Title
Anesthesia time (min.)
Time Frame
surgery
Title
Quality of life
Time Frame
12 months
Title
Sexual health
Time Frame
12 months
Title
Return to work
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl F Tamussino, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rene W Laky, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krankenhaus der Barmherzigen Brüder, Abteilung Gynäkologie
City
Graz
ZIP/Postal Code
8020
Country
Austria
Facility Name
Medical University of Graz/Dept. OB/GYN
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
LKH Leoben/Abteilung Gynäkologie
City
Leoben
ZIP/Postal Code
8700
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

Vaginal vs. Laparoscopic Hysterectomy

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