Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Vatche Arakel Minassian, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01594372
First received: May 4, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

Investigators intend to conduct a prospective randomized trial to compare vaginal hysterectomy with uterosacral colposuspension to laparoscopic supracervical hysterectomy with sacrocervicopexy. Both surgeries are minimally-invasive surgical standards of care for uterine prolapse repair. Nobody knows if one procedure is superior to the other, as they have not been compared directly. The investigators hypothesize that there is no difference in objective, subjective, or cost-effectiveness between the two procedures for up to two years after surgery.


Condition Intervention
Uterine Prolapse
Procedure: Laparoscopic supracervical hysterectomy with sacropexy
Procedure: Vaginal hysterectomy with uterosacral colposuspension

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Vaginal Hysterectomy to Laparoscopic Supracervical Hysterectomy With Vault Suspension for Symptomatic Uterine Prolapse

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Whether or not POPQ points AA, BA, Ap, or Bp are at less than 0 cm from the hymen OR whether point C descends less than 1/3 of the total vaginal length (TVL) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Absence of re-treatment for prolapse at 2 years [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • A negative response to "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?" [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    This is a question from the standardized questionnaire called Pelvic Floor Discomfort Inventory (PFDI).


Secondary Outcome Measures:
  • Changes in POPQ measurements [ Time Frame: baseline, 6 week, and 3, 12, and 24 months ] [ Designated as safety issue: No ]
  • Changes in Patient-reported quality of life scores from the EQ-5D, PFDI, PFIQ, SF-12, Standard Gamble Interview, Pain Scale and Activity Assessment [ Time Frame: baseline, 3, 12, and 24 months ] [ Designated as safety issue: No ]
    EQ-5D assesses a patient's health that day PFDI- pelvic floor discomfort questions PFIQ - pelvic floor impact on daily activity questions SF-12 - general health/quality of life questions Standard Gamble Interview - an overall general health/quality of life questionnaire

  • Change in patient reported sexual questionnaire, PISQ [ Time Frame: baseline, 3, 12 and 24 months ] [ Designated as safety issue: No ]
    PISQ - pelvic organ prolapse/urinary incontinence sexual questionnaire

  • Frequencies of surgical and post-operative complications [ Time Frame: up to 2 years post-operatively ] [ Designated as safety issue: No ]
    Complications will be classified and reported, based on severity.


Estimated Enrollment: 154
Study Start Date: January 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Laparoscopic Repair
Laparoscopic supracervical hysterectomy with sacropexy
Procedure: Laparoscopic supracervical hysterectomy with sacropexy
Will involve laparoscopic entry to the abdomen to remove the uterus and suspension of the cervix and vaginal cuff to the sacrum with mesh. We will allow surgeons to conduct the surgery as they have perfected it
Active Comparator: Vaginal Repair
Vaginal hysterectomy with uterosacral colposuspension
Procedure: Vaginal hysterectomy with uterosacral colposuspension
Will involve removing the uterus vaginally followed by suspending the vaginal cuff to the high (proximal) uterosacral ligaments bilaterally restoring the vagina to its normal axis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with primary symptomatic uterine prolapse
  • ≥ 18 years of age
  • Considering pelvic reconstructive surgery

Exclusion Criteria:

  • Unwillingness to be randomized to one of two surgical approaches
  • Pregnant or planning to maintain their future fertility
  • Unable to have general anesthesia
  • Currently undergoing chemotherapy OR has current or history of pelvic radiation
  • Previous adverse reaction to synthetic mesh
  • Recent history of abnormal paps (past 10 years)
  • Cervical or uterine cancers
  • Previous hysterectomy
  • Previous central vault or uterine prolapse repair
  • Uterus ≥ 14 weeks size
  • Uterine cancer
  • History of significant pelvic adhesive disease
  • Elongated cervix (length D to C > 6cm)
  • Fibroid ≥ 7cm
  • Post menopausal with enlarged uterus
  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: NCT01594372

Contacts
Contact: Rachel Podoski 617-525-7326 RPodoski@partners.org
Contact: Vatche A Minassian, MD, MPH 617-732-4838 VMinassian@partners.org

Locations
United States, Massachusetts
Brigham And Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Rachel Podoski       RPodoski@partners.org   
Principal Investigator: Vatche A Minassian, MD, MPH         
Sub-Investigator: Abraham (Nick) Morse, MD, MBA         
Sub-Investigator: Jon I. Einarrson, MD, MPH         
Sub-Investigator: Karen C Wang, MD         
Sub-Investigator: Sarah Cohen, MD         
Sub-Investigator: Neeraj Kohli, M.D., MBA         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Vatche A Minassian, MD, MPH Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Vatche Arakel Minassian, Director of Urogynecology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01594372     History of Changes
Other Study ID Numbers: VM-2012-01
Study First Received: May 4, 2012
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Uterine Prolapse
Laparoscopy
Hysterectomy, vaginal

Additional relevant MeSH terms:
Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on September 18, 2014