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

Fistula in Ano Clinical Trial

— FIX-IT1  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02686580
• Other study ID #: 1510144
• Status: Terminated
• Phase: Phase 3
• Start date: February 1, 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: February 2016
• Source: Royal Devon and Exeter NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Anorectal Abscess
• Fistula
• Fistula in Ano

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Royal Devon and Exeter NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula Healing rate at 3 months	Healing of fistula as evidenced by MRI of the ano-rectum.	3 months
Primary	Fistula Healing Rate at 12 months	This will be assessed by a telephonic questionnaire at 12 months following intervention	12 months
Secondary	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
Secondary	Faecal Incontinence questionnaire (Wexner)	To assess any adverse impact of intervention on continence	At recruitment, 7-10 days, 6 weeks and 6 months
Secondary	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
Secondary	Pain Score	Visual analogue score	At recruitment, 7-10 days, 6 weeks and 6 months