Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse
This study is currently recruiting participants.
Verified February 2013 by Brigham and Women's Hospital
Sponsor:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Vatche Arakel Minassian, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01594372
First received: May 4, 2012
Last updated: February 14, 2013
Last verified: February 2013
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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 2018 |
| Estimated Primary Completion Date: | January 2018 (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
- History of abnormal paps
- Cervical dysplasia or 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 > 4)
- Qualify for cervical amputation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594372
Contacts
| Contact: Kristin m King, MPPM | 617-525-7326 | kking20@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: Kristin M King kking20@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: | February 14, 2013 |
| 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 May 16, 2013