Clinical trial NCT05805449: BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma
Official title: The BIO RAMP Trial - BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anal Fistula
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES
First posted: 2023-04-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Number of participants with fistula recurrence
timeFrame: upto 6 months after surgery
measure: Change in Health-related quality of life (HRQoL) as assessed by the EQ-5D-5L questionnaire
timeFrame: Baseline, 1week post surgery, 2 weeks post surgery, 6 weeks post surgery, 3 months post surgery, 6 months post surgery, and 12 months post surgery.
Secondary outcomes:
measure: Number of participants who have post operative pain as assessed by the visual analog scale (VAS)
timeFrame: 14 days after surgery
measure: Change in fecal continence as assessed by the Cleveland Clinic Fecal Incontinence (CCFI) scoring tool
timeFrame: Baseline, 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery and 12 months after surgery
measure: The relative cost utility of the different treatment strategies as assessed by a questionnaire
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jeffrey L Van Eps, MD
role: PRINCIPAL_INVESTIGATOR
References: