Clinical trial NCT02686580: Feasibility Study to Assess the Early Use of Porcine Cross-linked Collagen Paste in Cryptoglandular Anorectal Fistulas
Official title: Feasibility Study to Assess the Early Use of Porcine Cross-linked Collagen Paste in Cryptoglandular Anorectal Fistulas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anorectal Abscess
Fistula in Ano
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-02-19
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: * 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

Primary outcomes:
measure: Fistula Healing rate at 3 months
timeFrame: 3 months
measure: Fistula Healing Rate at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Complication rate
timeFrame: 12 months
measure: Faecal Incontinence questionnaire (Wexner)
timeFrame: At recruitment, 7-10 days, 6 weeks and 6 months
measure: Faecal Incontinence quality of life questionnaire (FIQL)
timeFrame: At recruitment, 7-10 days, 6 weeks and 6 months
measure: Pain Score
timeFrame: At recruitment, 7-10 days, 6 weeks and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Royal Devon and Exeter NHS Foundation Trust
name: Neil J Smart, MBBS PhD FRCS
role: PRINCIPAL_INVESTIGATOR
References: