A Phase 3 interventional study of Collagen paste in Anorectal Abscess and Fistula in Ano, sponsored by Royal Devon and Exeter NHS Foundation Trust. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-12.
Sponsored by Royal Devon and Exeter NHS Foundation Trust · Phase 3, Interventional, and Treatment
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.
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.
731 studies on the registry are indexed under Fistula; 103 are open to participants now.
This study's enrollment of 2 is below the median of 60 across 484 interventional studies indexed under Fistula.
Browse Fistula studies →Royal Devon and Exeter NHS Foundation Trust is the lead sponsor of 62 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
o Clinical diagnosis of Cryptoglandular fistula in ano.
Insulin dependent diabetes
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
Healing of fistula as evidenced by MRI of the ano-rectum.
Time frame: 3 months
Fistula Healing Rate at 12 months
This will be assessed by a telephonic questionnaire at 12 months following intervention
Time frame: 12 months
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.
Time frame: 12 months
Faecal Incontinence questionnaire (Wexner)
To assess any adverse impact of intervention on continence
Time frame: At recruitment, 7-10 days, 6 weeks and 6 months
Faecal Incontinence quality of life questionnaire (FIQL)
To assess the impact on the quality of life of the participants
Time frame: At recruitment, 7-10 days, 6 weeks and 6 months
Pain Score
Visual analogue score
Time frame: At recruitment, 7-10 days, 6 weeks and 6 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Royal Devon and Exeter NHS Foundation Trust