Status:
COMPLETED
Permanent Versus Absorbable Colpopexy Trial
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Northwestern University
Augusta University
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Primary Aim: The primary aim of this randomized controlled trial (RCT) is to compare vaginal mesh and suture exposure rates in women undergoing robotic total hysterectomy and sacrocolpopexy with a li...
Detailed Description
Symptomatic pelvic organ prolapse is common and 13%1 to 19%2,3 of women undergo surgical repair. Reconstructive pelvic surgery is broadly divided into procedures that rely on existing native tissue ve...
Eligibility Criteria
Inclusion
- Age ≥18
- Subject must have apical with anterior or posterior vaginal prolapse with leading edge of prolapse to or beyond the hymen. This is defined as stage 2-4 pelvic organ prolapse ( C \> - (TVL / 2) AND Ba or Bp ≥ 0 by the POP)
- Subject reports a bothersome bulge they can see or feel per PFDI-20, question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit")
- Eligible for robotic or laparoscopic sacral colpopexy
- Desires surgical treatment for primary, symptomatic uterovaginal prolapse
- English speaking
- Willing to undergo hysterectomy
Exclusion
- Patients who had prior hysterectomy
- Patients who are not surgical candidates due to medical comorbidities
- Current foreign body complications (including but not limited to erosion, fistula, abscess). This covers foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft).
- Desires uterine conservation
- Inability to give informed consent or to complete the testing or data collection
- Anticipated circumstances resulting in an inability to follow up (geographic relocation, etc).
- Pregnant or intends to become pregnant
- Active/chronic systemic infection including any gynecologic infection, untreated UTI or tissue necrosis
- History of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
- Prior or currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
- Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
- Systemic connective tissue disease (e.g. scleroderma, Marfan's syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatica)
- Chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
- Poorly controlled diabetes mellitus (DM), as indicated by Hemoglobin A1c \> 9
- Those requiring concomitant rectopexy
- Subject is not able to conform to steep trendelenburg position
- Known sensitivity to polypropylene
Key Trial Info
Start Date :
April 7 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2019
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT02277925
Start Date
April 7 2015
End Date
October 7 2019
Last Update
November 19 2019
Active Locations (5)
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1
Augusta University Medical Center
Augusta, Georgia, United States, 30912
2
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
3
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27516
4
Carolinas HealthCare System
Charlotte, North Carolina, United States, 28207