Vaginal vs. Laparoscopic Hysterectomy

Not Applicable

Completed

• Conditions: Uterine Fibroids; Uterine Leiomyoma; Abnormal Uterine Bleeding, Unspecified
• Interventions: Procedure: Hysterectomy

• Registration Number: NCT02059954
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-11
• Primary Completion: 2016-08
• Study Completion: 2017-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total laparoscopic hysterectomy	Hysterectomy	Laparoscopic hysterectomy
Vaginal hysterectomy	Hysterectomy	Vaginal hysterectomy

Primary Outcome Measures

Name	Time	Method
Operating time (min.)	Surgery	Operating time (min.)

Secondary Outcome Measures

Name	Time	Method
Complications	6 weeks	Intraoperative and postoperative complications
Anesthesia time (min.)	surgery
Quality of life	12 months
Sexual health	12 months
Return to work	3 months

Trial Locations

Locations (3)

Krankenhaus der Barmherzigen Brüder, Abteilung Gynäkologie; 🇦🇹 Graz, Austria

LKH Leoben/Abteilung Gynäkologie; 🇦🇹 Leoben, Austria

Medical University of Graz/Dept. OB/GYN; 🇦🇹 Graz, Austria