Vaginal vs. Laparoscopic Hysterectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Medical University of Graz
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 18, 2014
Last verified: February 2014
  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 ]

Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 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
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

Contacts
Contact: Karl F Tamussino, MD +43 316 385 ext 12201 karl.tamussino@medunigraz.at
Contact: Rene W Laky, MD +43 316 385 ext 12201 rene.laky@klinikum-graz.at

Locations
Austria
Krankenhaus der Barmherzigen Brüder, Abteilung Gynäkologie Not yet recruiting
Graz, Austria, 8020
Contact: Peter FJ Lang, MD    +43 316 7067 ext 3102    peter.lang@bbgraz.at   
Principal Investigator: Peter FJ Lang, MD         
Medical University of Graz/Dept. OB/GYN Recruiting
Graz, Austria, 8036
Contact: Karl F Tamussino, MD    +43 316 385 ext 12201    karl.tamussino@medunigraz.at   
Contact: Rene W Laky, MD    +43 316 385 ext 12201    rene.laky@klinikum-graz.at   
Principal Investigator: Rene W Laky, MD         
LKH Leoben/Abteilung Gynäkologie Not yet recruiting
Leoben, Austria, 8700
Contact: George Ralph, MD    +43 3842 401 ext 2382    george.ralph@lkh-leoben.at   
Principal Investigator: George Ralph, MD         
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

No publications provided

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 18, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
Hysterectomy

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

ClinicalTrials.gov processed this record on October 30, 2014