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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen paste | Experimental | Injection of Permacol Collagen paste into the fistula tract. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen paste | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fistula Healing rate at 3 months | Healing of fistula as evidenced by MRI of the ano-rectum. | 3 months |
| Fistula Healing Rate at 12 months | This will be assessed by a telephonic questionnaire at 12 months following intervention | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Faecal Incontinence questionnaire (Wexner) |
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Inclusion Criteria:
o Clinical diagnosis of Cryptoglandular fistula in ano.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil J Smart, MBBS PhD FRCS | Royal Devon and Exeter NHS Foundation Trust | Principal Investigator |
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| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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To assess any adverse impact of intervention on continence |
| 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 | At recruitment, 7-10 days, 6 weeks and 6 months |
| Pain Score | Visual analogue score | At recruitment, 7-10 days, 6 weeks and 6 months |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |