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

NCT ID: NCT02686580

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2018-12-01

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.

Conditions

Anorectal Abscess; Fistula in Ano

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Collagen paste

Injection of Permacol Collagen paste into the fistula tract.

Group Type: EXPERIMENTAL

Collagen paste

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Devon and Exeter NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil J Smart, MBBS PhD FRCS

Role: PRINCIPAL_INVESTIGATOR

Royal Devon and Exeter NHS Foundation Trust

Other Identifiers

1510144

Identifier Type: -

Identifier Source: org_study_id