Vaginal vs. Laparoscopic Hysterectomy
Conditions
Uterine Fibroids - Uterine Leiomyoma - Abnormal Uterine Bleeding, Unspecified
Conditions: official terms
Leiomyoma - Myofibroma - Uterine Hemorrhage
Conditions: Keywords
Hysterectomy
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Hysterectomy
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Female
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
Locations
Krankenhaus der Barmherzigen Brüder, Abteilung Gynäkologie
Graz, Austria
Status: Not yet recruiting
Contact: Peter FJ Lang, MD - +43 316 7067 - peter.lang@bbgraz.at
Medical University of Graz/Dept. OB/GYN
Graz, Austria
Status: Recruiting
Contact: Karl F Tamussino, MD - +43 316 385 - karl.tamussino@medunigraz.at
LKH Leoben/Abteilung Gynäkologie
Leoben, Austria
Status: Not yet recruiting
Contact: George Ralph, MD - +43 3842 401 - george.ralph@lkh-leoben.at
Start Date
January 2014
Completion Date
July 2015
Sponsors
Medical University of Graz
Source
Medical University of Graz
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page