Overview

This trial is active, not recruiting.

Conditions uterine fibroids, uterine leiomyoma, abnormal uterine bleeding, unspecified
Treatment hysterectomy
Sponsor Medical University of Graz
Collaborator Austrian Urogynecology Working Group (AUWG)
Start date January 2014
End date August 2015
Trial size 100 participants
Trial identifier NCT02059954, 26-122 ex 13/14, MUG 26-122 ex 13/14

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Vaginal hysterectomy
hysterectomy
(Active Comparator)
Laparoscopic hysterectomy
hysterectomy

Primary Outcomes

Measure
Operating time (min.)
time frame: Surgery

Secondary Outcomes

Measure
Complications
time frame: 6 weeks
Anesthesia time (min.)
time frame: surgery
Quality of life
time frame: 12 months
Sexual health
time frame: 12 months
Return to work
time frame: 3 months

Eligibility Criteria

Female participants from 18 years up to 80 years old.

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

Additional Information

Official title Vaginal Hysterectomy Versus Total Laparoscopic Hysterectomy for Benign Indications: A Randomized Controlled Trial
Principal investigator Rene W Laky, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Medical University of Graz.