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

Phase 3

Terminated

• Conditions: Anorectal Abscess; Fistula in Ano
• Interventions: Biological: Collagen paste

• Registration Number: NCT02686580
• Lead Sponsor: Royal Devon and Exeter NHS Foundation Trust

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-12-01
• Status Verified: 2016-02
• Study Start: 2016-02-01
• Study First Submitted QC: 2016-02-15
• Study First Posted: 2016-02-19
• Primary Completion: 2018-10-01
• Study Completion: 2018-12-01
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Collagen paste	Collagen paste	Injection of Permacol Collagen paste into the fistula tract.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Faecal Incontinence questionnaire (Wexner)	At recruitment, 7-10 days, 6 weeks and 6 months	To assess any adverse impact of intervention on continence
Faecal Incontinence quality of life questionnaire (FIQL)	At recruitment, 7-10 days, 6 weeks and 6 months	To assess the impact on the quality of life of the participants
Complication rate	12 months	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.
Pain Score	At recruitment, 7-10 days, 6 weeks and 6 months	Visual analogue score