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Feasibility Study to Assess the Early Use of Porcine Cross-linked Collagen Paste in Cryptoglandular Anorectal Fistulas
FIX-IT1
1 other identifier
interventional
2
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2016
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
February 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedSeptember 12, 2019
February 1, 2016
2.7 years
December 1, 2015
September 10, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (4)
Complication rate
12 months
Faecal Incontinence questionnaire (Wexner)
At recruitment, 7-10 days, 6 weeks and 6 months
Faecal Incontinence quality of life questionnaire (FIQL)
At recruitment, 7-10 days, 6 weeks and 6 months
Pain Score
At recruitment, 7-10 days, 6 weeks and 6 months
Study Arms (1)
Collagen paste
EXPERIMENTALInjection of Permacol Collagen paste into the fistula tract.
Interventions
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.
Eligibility Criteria
You may qualify if:
- o Clinical diagnosis of Cryptoglandular fistula in ano.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neil J Smart, MBBS PhD FRCS
Royal Devon and Exeter NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2015
First Posted
February 19, 2016
Study Start
February 1, 2016
Primary Completion
October 1, 2018
Study Completion
December 1, 2018
Last Updated
September 12, 2019
Record last verified: 2016-02