NCT04085952

Anterior Prolapse Repair With and Without Graft Augmentation

Comparing Anterior Prolapse Repair With and Without Allograft Use: A Randomized Control Trial With Long Term Follow-Up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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).

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	dermal graft (ARCUS repliform) for anterior colporrhaphy	At the time of surgery patients were randomized to anterior colporrhaphy with dermal graft augmentation
PROCEDURE	suture based anterior colporrhaphy	At the time of surgery patients were randomized to anterior colporrhaphy with a suture based repair

Timeline

• Start date: 2005-01-01
• Primary completion: 2009-01-01
• Completion: 2016-01-01
• First posted: 2019-09-11
• Last updated: 2019-09-11