Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT01594372
Collaborator
(none)
14
1
2
27.9
0.5

Study Details

Study Description

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
  • Procedure: Laparoscopic supracervical hysterectomy with sacropexy
  • Procedure: Vaginal hysterectomy with uterosacral colposuspension
N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2013
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

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.

Outcome Measures

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) [24 months]

  2. Absence of re-treatment for prolapse at 2 years [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?" [24 months]

    This is a question from the standardized questionnaire called Pelvic Floor Discomfort Inventory (PFDI).

Secondary Outcome Measures

  1. Changes in POPQ measurements [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 [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 [baseline, 3, 12 and 24 months]

    PISQ - pelvic organ prolapse/urinary incontinence sexual questionnaire

  4. Frequencies of surgical and post-operative complications [up to 2 years post-operatively]

    Complications will be classified and reported, based on severity.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham And Women's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Brigham and Women's Hospital

Investigators

  • Principal Investigator: Vatche A Minassian, MD, MPH, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vatche Arakel Minassian, Director of Urogynecology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01594372
Other Study ID Numbers:
  • VM-2012-01
First Posted:
May 9, 2012
Last Update Posted:
Mar 4, 2022
Last Verified:
Mar 1, 2022
Keywords provided by Vatche Arakel Minassian, Director of Urogynecology, Brigham and Women's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 4, 2022