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Completed

NCT Number: NCT04085952

Anterior Prolapse Repair With and Without Graft Augmentation

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

dermal graft (ARCUS repliform) for anterior colporrhaphy

Procedure

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

suture based anterior colporrhaphy

Procedure

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

Primary outcomes

  1. 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

  2. 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. 1 Year composite score

    Time frame: 1 year post-operative

    Failure of prolapse surgery as measured as a composite outcome including anatomic failure measured by changes to Aa and Ba points to -1 or greater, "yes" to PFDI question #3, and retreatment with pessary or surgery for anterior compartment prolapse

  2. 7-10 years composite score

    Time frame: 7-10 years post-operative

    Failure of prolapse surgery as measured as a composite outcome including anatomic failure measured by changes to Aa and Ba points to -1 or greater, "yes" to PFDI question #3, and retreatment with pessary or surgery for anterior compartment prolapse

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Official study title

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

Acronym: ARCUS

Important dates

Study start
2005
Primary completion
2009
Study completion
2016
First posted
Sep 11, 2019
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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