NCT02686580

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Royal Devon and Exeter NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-10-01
• Completion: 2018-12-01
• First posted: 2016-02-19
• Last updated: 2019-09-12