Feasibility Study to Assess the Early Use of Porcine Cross-linked Collagen Paste in Cryptoglandular Anorectal Fistulas (FIX-IT1)
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|ClinicalTrials.gov Identifier: NCT02686580|
Recruitment Status : Unknown
Verified February 2016 by Royal Devon and Exeter NHS Foundation Trust.
Recruitment status was: Not yet recruiting
First Posted : February 19, 2016
Last Update Posted : February 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Anorectal Abscess Fistula in Ano||Biological: Collagen paste||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study to Assess the Early Use of Porcine Cross-linked Collagen Paste in Cryptoglandular Anorectal Fistulas|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||December 2017|
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.
- Fistula Healing rate at 3 months [ Time Frame: 3 months ]Healing of fistula as evidenced by MRI of the ano-rectum.
- Fistula Healing Rate at 12 months [ Time Frame: 12 months ]This will be assessed by a telephonic questionnaire at 12 months following intervention
- Complication rate [ Time Frame: 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.
- Faecal Incontinence questionnaire (Wexner) [ Time Frame: 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) [ Time Frame: At recruitment, 7-10 days, 6 weeks and 6 months ]To assess the impact on the quality of life of the participants
- Pain Score [ Time Frame: At recruitment, 7-10 days, 6 weeks and 6 months ]Visual analogue score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686580
|Contact: Sunil K Narang, MBBS MS MRCSfirstname.lastname@example.org|
|Contact: Tracy M Noone, MB BChBAO MRCSemail@example.com|
|Principal Investigator:||Neil J Smart, MBBS PhD FRCS||Royal Devon and Exeter NHS Foundation Trust|