Feasibility Study to Assess the Early Use of Porcine Cross-linked Collagen Paste in Cryptoglandular Anorectal Fistulas (FIX-IT1)

This study is designed to assess the effectiveness of porcine cross-linked collagen paste for the treatment of patients with ano-rectal abscess with underlying cryptoglandular fistula in ano.

Study Overview

• Status: Terminated
• Conditions: Fistula in Ano; Anorectal Abscess
• Intervention / Treatment: Biological: Collagen paste

Detailed Description

Most anal fistulae are thought to arise as a result of the infection of anal glands. This infection frequently presents as an anorectal abscess which requires drainage of the abscess under a general anaesthetic. Abscess and fistula should be considered as the acute and chronic phase of the same anorectal infection.The abscess represents the acute inflammatory event, whereas the fistula is representative of the chronic process. At the time of drainage of the anorectal abscess, the underlying fistulas frequently go undetected. As a result, patients present with a fistula in ano several months later.

In this study, the investigators aim to identify the underlying fistula in patients with a perianal abscess with the help of an MRI Scan done in the acute setting. Participants with a confirmed fistula on the MRI scan have their abscess treated as per convention. However, a repeat examination under anaesthetic is performed 7-'10 days later when the fistula tract is identified and treated with injection of the porcine collagen paste into the fistula tract. Participants are followed up clinically and radiologically to assess the effectiveness of the intervention.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• Inclusion Criteria:

  o Clinical diagnosis of Cryptoglandular fistula in ano.

• Exclusion Criteria:

  • Insulin dependent diabetes
  • Thyroid disease
  • Fistula secondary to Crohn's disease/Ulcerative Colitis
  • Clinical or radiological evidence of secondary tracts.
  • Complex fistula tracts on MRI scan such as Horseshoe fistula, anorectal-vaginal fistula
  • Patients refusing informed consent for admission to the study.
  • Previous fistulotomy/fistulectomy
  • Pregnancy
  • Patients unable to consent
  • Patients not suitable for MRI scan those with- Cochlear implant, Permanent pacemaker, Implanted metal work, Aneurysm clips, Claustrophobia, Metallic foreign body

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collagen paste; Injection of Permacol Collagen paste into the fistula tract.	Biological: Collagen paste; Permacol cross-linked collagen paste, 2.5-3.5 mls to be injected into the MRI defined fistula tracts 7-10 days following drainage of the anorectal abscess.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fistula Healing rate at 3 months	Healing of fistula as evidenced by MRI of the ano-rectum.	3 months
Fistula Healing Rate at 12 months	This will be assessed by a telephonic questionnaire at 12 months following intervention	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	Any complications resulting from participation in the the trial will be assessed on clinical and telephonic follow up. Clavien and Dindo Classification will be used to assess the severity of complications.	12 months
Faecal Incontinence questionnaire (Wexner)	To assess any adverse impact of intervention on continence	At recruitment, 7-10 days, 6 weeks and 6 months
Faecal Incontinence quality of life questionnaire (FIQL)	To assess the impact on the quality of life of the participants	At recruitment, 7-10 days, 6 weeks and 6 months
Pain Score	Visual analogue score	At recruitment, 7-10 days, 6 weeks and 6 months

Collaborators and Investigators

• Sponsor: Royal Devon and Exeter NHS Foundation Trust
• Investigators: Principal Investigator: Neil J Smart, MBBS PhD FRCS, Royal Devon and Exeter NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: December 1, 2015
• First Submitted That Met QC Criteria: February 15, 2016
• First Posted (Estimate): February 19, 2016

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Fistula
• Other Study ID Numbers: 1510144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided