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Anterior Prolapse Repair With and Without Graft Augmentation

NCT04085952 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2019-09-11

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Endeavor Health

    lead OTHER

Principal Investigators

  • Peter Sand, MD · North Shore Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2009-01-31
Completion
2016-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04085952 on ClinicalTrials.gov