Anorectal AbscessPhase 3FIX-IT1NCT02686580
Feasibility Study to Assess the Early Use of Porcine Cross-linked Collagen Paste in Cryptoglandular Anorectal Fistulas
A Phase 3 study testing Collagen paste in people with Anorectal Abscess and Fistula in Ano, run by Royal Devon and Exeter NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorectal Abscess, Fistula in Ano
- What is being tested?
- Collagen paste
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 1 Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- o Clinical diagnosis of Cryptoglandular fistula in ano.
Who cannot join
- 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.
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- 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
About this study
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.
Read the 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.
- Conditions
- Anorectal Abscess, Fistula in Ano
- Being tested
- Collagen paste
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen pasteBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Collagen paste | Experimental | Injection of Permacol Collagen paste into the fistula tract. Receives: Biological: Collagen paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula Healing rate at 3 months
Healing of fistula as evidenced by MRI of the ano-rectum.
Measured: 3 months
Fistula Healing Rate at 12 months
This will be assessed by a telephonic questionnaire at 12 months following intervention
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 12 months
Faecal Incontinence questionnaire (Wexner)
To assess any adverse impact of intervention on continence
Measured: 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
Measured: At recruitment, 7-10 days, 6 weeks and 6 months
Pain Score
Visual analogue score
Measured: At recruitment, 7-10 days, 6 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study start1 Feb 2016
- Primary completion1 Oct 2018
- Study completion1 Dec 2018
Why it stopped: Unable to recruit participants for this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil J Smart, MBBS PhD FRCS, Principal investigator, Royal Devon and Exeter NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686580
- Sponsor's protocol ID
- 1510144
- Acronym
- FIX-IT1
- Status last verified
- Feb 2016
- First submitted
- 1 Dec 2015
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Assess the Early Use of Porcine Cross-linked Collagen Paste in Cryptoglandular Anorectal Fistulas
- ClinicalTrials.gov ID
- NCT02686580
- Acronym / sponsor ID
- FIX-IT1 / 1510144
- Conditions
- Anorectal Abscess, Fistula in Ano
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit participants for this study
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collagen paste | Experimental | Biological: Collagen pasteInjection of Permacol Collagen paste into the fistula tract. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- o Clinical diagnosis of Cryptoglandular fistula in ano.
Key exclusion criteria (10 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen pastePermacol 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. | Biological | Collagen paste |
Primary outcome
Fistula Healing rate at 3 months
Time frame: 3 months
Healing of fistula as evidenced by MRI of the ano-rectum.
Fistula Healing Rate at 12 months
Time frame: 12 months
This will be assessed by a telephonic questionnaire at 12 months following intervention
4 secondary outcomes
Complication rate
Time frame: 12 months
Faecal Incontinence questionnaire (Wexner)
Time frame: At recruitment, 7-10 days, 6 weeks and 6 months
Faecal Incontinence quality of life questionnaire (FIQL)
Time frame: At recruitment, 7-10 days, 6 weeks and 6 months
Pain Score
Time frame: At recruitment, 7-10 days, 6 weeks and 6 months
Results and safety
The study was stopped early (reason given: Unable to recruit participants for this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil J Smart, MBBS PhD FRCS principal investigator
Royal Devon and Exeter NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Collagen paste in people with Anorectal Abscess and Fistula in Ano, run by Royal Devon and Exeter NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit participants for this study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fistula Healing rate at 3 months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.