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Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01594372
Recruitment Status : Terminated (Laproscopic procedure not offered at this time; will not be offered for the foreseeable, thus we are unable to randomize participants between the two arms.)
First Posted : May 9, 2012
Last Update Posted : May 8, 2015
Information provided by (Responsible Party):
Vatche Arakel Minassian, Brigham and Women's Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Uterine Prolapse Procedure: Laparoscopic supracervical hysterectomy with sacropexy Procedure: Vaginal hysterectomy with uterosacral colposuspension Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Vaginal Hysterectomy to Laparoscopic Supracervical Hysterectomy With Vault Suspension for Symptomatic Uterine Prolapse
Study Start Date : January 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]
  2. Absence of re-treatment for prolapse at 2 years [ Time Frame: 24 months ]
  3. 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 ]
    This is a question from the standardized questionnaire called Pelvic Floor Discomfort Inventory (PFDI).

Secondary Outcome Measures :
  1. Changes in POPQ measurements [ Time Frame: baseline, 6 week, and 3, 12, and 24 months ]
  2. 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 ]
    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

  3. Change in patient reported sexual questionnaire, PISQ [ Time Frame: baseline, 3, 12 and 24 months ]
    PISQ - pelvic organ prolapse/urinary incontinence sexual questionnaire

  4. Frequencies of surgical and post-operative complications [ Time Frame: up to 2 years post-operatively ]
    Complications will be classified and reported, based on severity.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01594372

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United States, Massachusetts
Brigham And Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
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Principal Investigator: Vatche A Minassian, MD, MPH Brigham and Women's Hospital
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Responsible Party: Vatche Arakel Minassian, Director of Urogynecology, Brigham and Women's Hospital Identifier: NCT01594372    
Other Study ID Numbers: VM-2012-01
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015
Keywords provided by Vatche Arakel Minassian, Brigham and Women's Hospital:
Uterine Prolapse
Hysterectomy, vaginal
Additional relevant MeSH terms:
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Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Pelvic Organ Prolapse