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Vaginal vs. Laparoscopic Hysterectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Austrian Urogynecology Working Group (AUWG)
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT02059954
First received: February 10, 2014
Last updated: February 1, 2016
Last verified: February 2016
  Purpose

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 Intervention
Uterine Fibroids
Uterine Leiomyoma
Abnormal Uterine Bleeding, Unspecified
Procedure: Hysterectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vaginal Hysterectomy Versus Total Laparoscopic Hysterectomy for Benign Indications: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Operating time (min.) [ Time Frame: Surgery ] [ Designated as safety issue: No ]
    Operating time (min.)


Secondary Outcome Measures:
  • Complications [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Intraoperative and postoperative complications

  • Anesthesia time (min.) [ Time Frame: surgery ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Sexual health [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Return to work [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: September 2016
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vaginal hysterectomy
Vaginal hysterectomy
Procedure: Hysterectomy
Active Comparator: Total laparoscopic hysterectomy
Laparoscopic hysterectomy
Procedure: Hysterectomy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059954

Locations
Austria
Krankenhaus der Barmherzigen Brüder, Abteilung Gynäkologie
Graz, Austria, 8020
Medical University of Graz/Dept. OB/GYN
Graz, Austria, 8036
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
  More Information

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT02059954     History of Changes
Other Study ID Numbers: 26-122 ex 13/14  MUG 26-122 ex 13/14 
Study First Received: February 10, 2014
Last Updated: February 1, 2016
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
Hysterectomy

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Uterine Hemorrhage
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on September 26, 2016