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

Not Applicable

Recruiting

• Conditions: Anal Fistula
• Interventions: Procedure: Surgery; Other: Platelet-rich plasma (PRP); Device: Matrix

• Registration Number: NCT05805449
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-21
• Study First Submitted: 2023-03-16
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-05
• Last Update Submitted: 2023-04-05
• Study First Posted: 2023-04-10
• Last Update Posted: 2023-04-10
• Primary Completion: 2026-02-28
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery	Surgery	Control patients will receive usual standard of care surgical repair of their complex fistula by The ligation of intersphincteric tract (LIFT) or advancement flap technique without any biologic adjunct.
Surgery plus matrix	Surgery	-
Surgery plus PRP plus matrix material	Matrix	-
Surgery plus PRP plus matrix material	Platelet-rich plasma (PRP)	-
Surgery plus platelet-rich plasma (PRP)	Platelet-rich plasma (PRP)	-
Surgery plus platelet-rich plasma (PRP)	Surgery	-
Surgery plus matrix	Matrix	-
Surgery plus PRP plus matrix material	Surgery	-

Primary Outcome Measures

Name	Time	Method
Number of participants with fistula recurrence	upto 6 months after surgery	A fistula recurrence is defined as one or more of the following clinical signs or symptoms after repair: recurrent abscess at the site of repair, chronic drainage or passage of flatus from an external opening of the perineum away from the anal verge, a non-healing external opening that tracks toward anus by probing with fistula probe.
Change in Health-related quality of life (HRQoL) as assessed by the EQ-5D-5L questionnaire	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.	This instrument queries subjects on health status related to mobility, self-care, 'usual' activities, pain/discomfort, and anxiety/depression with 5 potential responses ranging from "no problems" to inability to complete the task or extreme levels of pain/depression, correlating to a discrete index score from 1-5, a higher number indicating a worse outcome.The instrument also includes an overall VAS self-rating of health ranging from 0-100, higher number indicating better health.

Secondary Outcome Measures

Name	Time	Method
Change in fecal continence as assessed by the Cleveland Clinic Fecal Incontinence (CCFI) scoring tool	Baseline, 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery and 12 months after surgery	This is a 5 item questionnaire that assesses type of incontinence (solid, liquid, gas, wears pad, lifestyle alteration).; The frequency with which each type of incontinence occurs is rated on a scale from 0 (never) to 4 (always or to 1/day). The sum of the frequencies is added to yield a total score that can range from 0 to 20, with higher scores indicating higher levels of incontinence.
Number of participants who have post operative pain as assessed by the visual analog scale (VAS)	14 days after surgery	This is scored from 0-100, higher number indicating better health
The relative cost utility of the different treatment strategies as assessed by a questionnaire	12 months after surgery	A cost effectiveness analysis (CEA) will be done from the healthcare system perspective assessed as the incremental health system costs (or savings) per fistula recurrence prevented

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States