Anterior Prolapse Repair With and Without Graft Augmentation

NCT04085952 | Completed

• 1 other identifier: EH04-302
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapse, vaginal graft

Outcome Measures

Primary Outcomes (2)

• 1-Year Recurrent prolapse- anatomic

  Failure of prolapse surgery as measured by changes in POPQ measurements, Aa and Ba to -1 or greater

  1 year post-operative

• 7-10 Years Recurrent prolapse-anatomic

  Failure of prolapse surgery as measured by changes in POPQ measurements, Aa and Ba to -1 or greater

  7-10 years post-operative

Secondary Outcomes (2)

• 1 Year composite score

  1 year post-operative

• 7-10 years composite score

  7-10 years post-operative

Study Arms (2)

anterior colporrhaphy with dermal graft

EXPERIMENTAL

Patients randomized to this arm underwent anterior colporrhaphy with dermal graft augmentation (ARUCS) during their surgery for pelvic organ prolapse.

Procedure: dermal graft (ARCUS repliform) for anterior colporrhaphy

anterior colporrhaphy suture based

ACTIVE COMPARATOR

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.

Procedure: suture based anterior colporrhaphy

Interventions

dermal graft (ARCUS repliform) for anterior colporrhaphy PROCEDURE

At the time of surgery patients were randomized to anterior colporrhaphy with dermal graft augmentation

anterior colporrhaphy with dermal graft

suture based anterior colporrhaphy PROCEDURE

At the time of surgery patients were randomized to anterior colporrhaphy with a suture based repair

anterior colporrhaphy suture based

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Endeavor Health: lead

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Sand, MD

  North Shore Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: September 11, 2019
• Study Start: January 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2016
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share