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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
Sponsor:
Information provided by (Responsible Party):
Royal Devon and Exeter NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Anorectal Abscess Fistula in Ano Biological: Collagen paste Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess Fistulas
Drug Information available for: Collagen

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Fistula Healing rate at 3 months [ Time Frame: 3 months ]
    Healing of fistula as evidenced by MRI of the ano-rectum.

  2. Fistula Healing Rate at 12 months [ Time Frame: 12 months ]
    This will be assessed by a telephonic questionnaire at 12 months following intervention


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. Pain Score [ Time Frame: At recruitment, 7-10 days, 6 weeks and 6 months ]
    Visual analogue score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Sunil K Narang, MBBS MS MRCS 0044-7823442661 drsunilkumarnarang@gmail.com
Contact: Tracy M Noone, MB BChBAO MRCS 0044-13928943 tracy_noone@yahoo.com

Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
Investigators
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Principal Investigator: Neil J Smart, MBBS PhD FRCS Royal Devon and Exeter NHS Foundation Trust

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Responsible Party: Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02686580     History of Changes
Other Study ID Numbers: 1510144
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Fistula
Pathological Conditions, Anatomical