Comparing Anterior Prolapse Repair With and Without Allograft Use: A Randomized Control Trial With Long Term Follow-Up
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 114
- Primary Endpoint
- 1-Year Recurrent prolapse- anatomic
Study Overview
Brief Summary
This is a randomized control trial comparing anterior colporrhaphy with augmentation with dermal allograft (ARCUS) to anterior colporrhaphy with a suture-based repair (native tissue). Patients were randomized to one treatment and then were followed post-operatively for 7-10 years. Prior to surgery patients had a POPQ vaginal prolapse exam and completed a quality of life questionaire (PFDI). They had a repeat POPQ exam and quality of life questionaires at their post-op operative visits. We compare recurrent prolapse rates between these 2 groups.
Detailed Description
Objective
To determine whether dermal allograft (ARCUS) reduces anterior prolapse recurrence at 1 and 7-10 years post-operatively. Our central question is whether we can reduce the rate of rate of anterior compartment prolapse recurrence after surgical repair, is the recurrence rate reduced with allograft use, and does this benefit hold up over time?
Methods: Patient will be randomized by computer generated block randomization to native tissue (suture based) anterior colporrhaphy or colporrhaphy with graft (ARCUS) usage. Neither patients nor surgeons will be blinded due to the nature of the surgery. Patients will be followed for 7-10 years post-operatively. Participants will complete a POPQ exam and the PFDI (Pelvic Floor Distress Inventory) questionnaire pre-operatively. Patients will return for a POPQ exam at 1 year post-operatively and complete the PFDI (Pelvic Floor Distress Inventory) and PISQ (Sexual Function for Women with: POP, Urinary Incontinence and/or Fecal Incontinence) questionnaires. Patients will be asked to return to the office for a research visit 7-10 years post-operatively for a POPQ exam and to complete quality of life questionnaires including PFDI 20 (Pelvic floor distress inventory), PISQ-R (Sexual Function for Women with: POP, Urinary Incontinence and/or Fecal Incontinence, Revised), and PGI (Patient global assessment of improvement).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Any patient planning to undergo surgery for anterior compartment prolapse, English speaking.
Exclusion Criteria
- •Any patient who does not speak English due to standardized English language based questionaires, and patients without anterior compartment prolapse.
Arms & Interventions
anterior colporrhaphy with dermal graft
Patients randomized to this arm underwent anterior colporrhaphy with dermal graft augmentation (ARUCS) during their surgery for pelvic organ prolapse.
Intervention: dermal graft (ARCUS repliform) for anterior colporrhaphy (Procedure)
anterior colporrhaphy suture based
Patients randomized to this arm underwent anterior colporrhaphy with suture based repair (native tissue) during their surgery for pelvic organ prolapse. This is and was the most common practice for anterior colporrhaphy.
Intervention: suture based anterior colporrhaphy (Procedure)
Outcomes
Primary Outcomes
1-Year Recurrent prolapse- anatomic
Time Frame: 1 year post-operative
Failure of prolapse surgery as measured by changes in POPQ measurements, Aa and Ba to -1 or greater
7-10 Years Recurrent prolapse-anatomic
Time Frame: 7-10 years post-operative
Failure of prolapse surgery as measured by changes in POPQ measurements, Aa and Ba to -1 or greater
Secondary Outcomes
- 1 Year composite score(1 year post-operative)
- 7-10 years composite score(7-10 years post-operative)