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NCT02059954 Clinical Trial

Vaginal vs. Laparoscopic Hysterectomy

Uterine Fibroids Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02059954
Other study ID # 26-122 ex 13/14
Secondary ID MUG 26-122 ex 13
Status Completed
Phase N/A
First received February 10, 2014
Last updated April 16, 2018
Start date January 2014
Est. completion date September 2017

Study information
Verified date April 2018
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date September 2017
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Hysterectomy

Locations
Country Name City State
Austria Krankenhaus der Barmherzigen Brüder, Abteilung Gynäkologie Graz
Austria Medical University of Graz/Dept. OB/GYN Graz
Austria LKH Leoben/Abteilung Gynäkologie Leoben

Sponsors (2)
Lead Sponsor Collaborator
Medical University of Graz Austrian Urogynecology Working Group (AUWG)

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Operating time (min.) Operating time (min.) Surgery
Secondary Complications Intraoperative and postoperative complications 6 weeks
Secondary Anesthesia time (min.) surgery
Secondary Quality of life 12 months
Secondary Sexual health 12 months
Secondary Return to work 3 months
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