RECRUITING

BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to compare the clinical effectiveness of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix (UBM) to usual surgical care alone to prevent fistula recurrence or improve HRQoL, to compare the effects of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix on early postoperative pain and fecal continence and to assess the cost utility of augmented complex fistula repair relative to usual surgical care

Official Title

The BIO RAMP Trial - BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma

Quick Facts

Study Start:2023-02-21
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05805449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * complex cryptoglandular transsphincteric anal fistula undergoing surgical repair by LIFT or advancement flap procedure
  2. * English or Spanish speaking and capable of providing informed consent
  3. * Willing to undergo temporary anal seton drainage for requisite time prior to repair
  4. * Participating surgeons will only be eligible if they perform at least 3 repair procedures/year
  1. * Unable to reliably complete follow up for 12 months postoperatively
  2. * Primary platelet disorders
  3. * Thrombocytopenia \< 150 plt/microliter
  4. * Inability to stop anti-platelet agent \> 5 days preoperatively
  5. * Fistula associated with inflammatory bowel disease (IBD), malignancy or pelvic/perineal radiation

Contacts and Locations

Study Contact

Jeffrey L Van Eps, MD
CONTACT
713-486-4600
Jeffrey.L.VanEps@uth.tmc.edu
Angielyn Rivera
CONTACT
713-416-1350
Angielyn.R.Rivera@uth.tmc.edu

Principal Investigator

Jeffrey L Van Eps, MD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Jeffrey L Van Eps, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-21
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-02-21
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Anal Fistula