Surgical repair of complex anal fistula using enhanced techniques
The BIO RAMP Trial - BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma
NA · The University of Texas Health Science Center, Houston · NCT05805449
This study is testing if adding special treatments like platelet-rich plasma or pig bladder to surgery for complex anal fistulas can help people heal better and have fewer problems afterward compared to regular surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05805449 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of augmenting surgical repair of complex anal fistulas with autologous platelet-rich plasma (PRP) and/or acellular porcine urinary bladder matrix compared to standard surgical care. It will assess outcomes such as fistula recurrence, postoperative pain, and fecal continence, as well as the cost-effectiveness of these augmented techniques. Participants will undergo surgical procedures like LIFT or advancement flap, and the study will involve a follow-up period of 12 months to monitor results.
Who should consider this trial
Good fit: Ideal candidates include individuals with complex cryptoglandular transsphincteric anal fistulas who are undergoing surgical repair.
Not a fit: Patients with primary platelet disorders, inflammatory bowel disease, or those unable to complete follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of anal fistulas and improve patients' quality of life.
How similar studies have performed: Other studies have shown promise in using similar augmentation techniques for surgical repairs, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * complex cryptoglandular transsphincteric anal fistula undergoing surgical repair by LIFT or advancement flap procedure * English or Spanish speaking and capable of providing informed consent * Willing to undergo temporary anal seton drainage for requisite time prior to repair * Participating surgeons will only be eligible if they perform at least 3 repair procedures/year Exclusion Criteria: * Unable to reliably complete follow up for 12 months postoperatively * Primary platelet disorders * Thrombocytopenia \< 150 plt/microliter * Inability to stop anti-platelet agent \> 5 days preoperatively * Fistula associated with inflammatory bowel disease (IBD), malignancy or pelvic/perineal radiation
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Jeffrey L Van Eps, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Jeffrey L Van Eps, MD
- Email: Jeffrey.L.VanEps@uth.tmc.edu
- Phone: 713-486-4600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anal Fistula