Vaginal vs. Laparoscopic Hysterectomy

• Sponsor: Medical University of Graz (Other)
• Overall Status: Completed
• CT.gov ID: NCT02059954
• Collaborator: Austrian Urogynecology Working Group (AUWG) (Other)
• Enrollment: 100
• Locations: 3
• Arms: 2
• Actual Duration (Months): 44
• Patients Per Site: 33.3
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroids; Uterine Leiomyoma; Abnormal Uterine Bleeding, Unspecified	Procedure: Hysterectomy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Vaginal Hysterectomy Versus Total Laparoscopic Hysterectomy for Benign Indications: A Randomized Controlled Trial
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Operating time (min.) [Surgery]

   Operating time (min.)

Secondary Outcome Measures

1. Complications [6 weeks]

   Intraoperative and postoperative complications

2. Anesthesia time (min.) [surgery]

3. Quality of life [12 months]

4. Sexual health [12 months]

5. Return to work [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Krankenhaus der Barmherzigen Brüder, Abteilung Gynäkologie	Graz		Austria	8020
2	Medical University of Graz/Dept. OB/GYN	Graz		Austria	8036
3	LKH Leoben/Abteilung Gynäkologie	Leoben		Austria	8700

Sponsors and Collaborators

• Medical University of Graz
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Graz
• ClinicalTrials.gov Identifier: NCT02059954
• Other Study ID Numbers: 26-122 ex 13/14; MUG 26-122 ex 13/14
• First Posted: Feb 11, 2014
• Last Update Posted: Apr 17, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by Medical University of Graz: Hysterectomy
• Additional relevant MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage

Study Results

No Results Posted as of Apr 17, 2018