Fistula-in-anoNCT06386835
Collagen Paste vs Mucosal Advancement Flap for FIA
A study testing Collagen Paste and Mucosal advancement in people with Fistula-in-ano, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
The treatment for fistula-in-ano (FIA) remains a challenge to General and Colorectal Surgeons Worldwide. A variety of surgical treatments have been described for high anal fistulas, but none offers the panacea of fistula eradication with guaranteed preservation of continence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fistula-in-ano
- What is being tested?
- Collagen Paste and Mucosal advancement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesHong Kong
- Study dates
- 26 Jan 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Clinical diagnosis of high cryptoglandular fistula-in-ano.
- Patients must have undergone a prior EUA to characterise the nature of the fistula.
- The fistula tract should be ≥ 2 cm in length.
- Only a single internal fistula opening should be present at EUA, such that the fistula is suitable for treatment by insertion of a seton drain.
- Patients must have been treated with a draining seton for a minimum period of 6 weeks prior to randomisation.
- Patients must be aged ≥ 18 years and able to provide informed consent.
- Fistulas must be of cryptoglandular aetiology.
Who cannot join
- Unable/unwilling to provide informed consent.
- Contraindication to general anaesthesia or spinal anaesthesia.
- Low trans-sphincteric fistulas.
- Non-cryptoglandular fistulas (e.g. Crohn's disease, obstetric, irradiation, malignant, etc.).
- Other perineal fistulas (e.g. rectovaginal fistulas, pouch-vaginal fistulas, etc.).
- Complex disease in which more than one internal fistula opening is present and requiring concurrent insertion of more than one fistula plug.
Show all 10Show fewer
- Clinical evidence of active perianal sepsis. In the event that there is disagreement between clinical and radiological assessment of active sepsis/collection, the clinical opinion will prevail.
- Cultural or religious objection to the use of pig tissue.
- Absolute contraindication to magnetic resonance imaging (MRI) (e.g. cardiac pacemaker).
- Patients with recurrent anal fistulas previously treated with a fistula plug.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Recruiting
Department of Surgery, Chinese University of Hong Kong
Shatin, New Territories
Kaori Futaba, kfutaba@surgery.cuhk.edu.hk
- Recruiting
Prince of Wlaes Hospital
Shatin
Kaori Futaba, 35051495, kfutaba@surgery.cuhk.edu.hk
About this study
Official title: Collagen Paste Injection Compared With Mucosal Advancement Flap for the Treatment of Fistula-in-ano: Single Centre Non-inferiority Randomised Controlled Trial
The treatment for fistula-in-ano (FIA) remains a challenge to General and Colorectal Surgeons Worldwide. A variety of surgical treatments have been described for high anal fistulas, but none offers the panacea of fistula eradication with guaranteed preservation of continence. This study compares Collagen paste injection to mucosal advancement flap for the treatment of fistula-in-ano.
Read the detailed description
Rectal advancement flaps have been advocated as a means of closing high fistulas with preservation of the external sphincter muscle. With this technique, it shows promising results with success rate of approximately 60%. However, complications have been reported, in particular with a change of continence in 30-35% of patients.
Collagen paste is a novel sphincter-preserving method for fistula closure. Permacol (Medtronic, USA) is a sterile acellular cross-linked porcine dermal collagen matrix suspension. The paste-like suspension form a matrix that accelerates neovascularization, cellular infiltration which promotes healing and fistula closure. The theoretical benefits of paste form compared to previous collagen plug design is that the collagen can moulded into the fistula cavity or tract. This allows better tissue contact with the collagen thus improves healing and reduces the chance of dislodgement. Limited data is available to date. Success rates of collagen paste range from 47.6% to 63%. Hence it has a potential to be the first-line treatment for high FIA with low complication rates and without causing disruption to the anal sphincter complex.
- Conditions
- Fistula-in-ano
- Being tested
- Collagen Paste, Mucosal advancement
- 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 PasteProcedure or surgery
Collagen paste injection
Mucosal advancementProcedure or surgery
Mucosal advancement flap
| Study group | Role | What they receive |
|---|---|---|
| Collagen Paste | Experimental | Seton is removed, the fistula tract is de-epithelialised and collagen paste applied. Receives: Procedure: Collagen Paste |
| Mucosal Advancement Flap | Active comparator | The internal opening is excised and is covered with a "U-shape" rectal mucosal flap Receives: Procedure: Mucosal advancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical healing of Fistula-in-ano
Clinical healing of the fistula-in-ano
Measured: 1 year
Secondary outcomes (5)
30-day morbidity
30-day morbidity using Clavien-Dindo classification
Measured: 30 days
Quality of life score
Assess effect on Quality of life post operatively using Short Form 36 Health Survey
Measured: 1 year
Postoperative pain score
assessment of postoperative pain using visual analog score from 0 (no pain) to 10 (severe pain)
Measured: 1 week
Faecal incontinence rate
Assess postoperative effect on continence
Measured: 1 year
Hospital readmission rate
Assess hospital re-admission rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start26 Jan 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fistula-in-anoStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaori Futaba, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386835
- Sponsor's protocol ID
- CREC2021.724-T
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagen Paste Injection Compared With Mucosal Advancement Flap for the Treatment of Fistula-in-ano: Single Centre Non-inferiority Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06386835
- Acronym / sponsor ID
- CREC2021.724-T
- Conditions
- Fistula-in-ano
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 26 Apr 2024 (actual)
- 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.
The treatment for fistula-in-ano (FIA) remains a challenge to General and Colorectal Surgeons Worldwide. A variety of surgical treatments have been described for high anal fistulas, but none offers the panacea of fistula eradication with guaranteed preservation of continence. This study compares Collagen paste injection to mucosal advancement flap for the treatment of fistula-in-ano.
Detailed description
Rectal advancement flaps have been advocated as a means of closing high fistulas with preservation of the external sphincter muscle. With this technique, it shows promising results with success rate of approximately 60%. However, complications have been reported, in particular with a change of continence in 30-35% of patients.
Collagen paste is a novel sphincter-preserving method for fistula closure. Permacol (Medtronic, USA) is a sterile acellular cross-linked porcine dermal collagen matrix suspension. The paste-like suspension form a matrix that accelerates neovascularization, cellular infiltration which promotes healing and fistula closure. The theoretical benefits of paste form compared to previous collagen plug design is that the collagen can moulded into the fistula cavity or tract. This allows better tissue contact with the collagen thus improves healing and reduces the chance of dislodgement. Limited data is available to date. Success rates of collagen paste range from 47.6% to 63%. Hence it has a potential to be the first-line treatment for high FIA with low complication rates and without causing disruption to the anal sphincter complex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagen Paste | Experimental | Procedure: Collagen PasteSeton is removed, the fistula tract is de-epithelialised and collagen paste applied. |
| Mucosal Advancement Flap | Active comparator | Procedure: Mucosal advancementThe internal opening is excised and is covered with a "U-shape" rectal mucosal flap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of high cryptoglandular fistula-in-ano.
- Patients must have undergone a prior EUA to characterise the nature of the fistula.
- The fistula tract should be ≥ 2 cm in length.
- Only a single internal fistula opening should be present at EUA, such that the fistula is suitable for treatment by insertion of a seton drain.
- Patients must have been treated with a draining seton for a minimum period of 6 weeks prior to randomisation.
Key exclusion criteria (10 listed)
- Unable/unwilling to provide informed consent.
- Contraindication to general anaesthesia or spinal anaesthesia.
- Low trans-sphincteric fistulas.
- Non-cryptoglandular fistulas (e.g. Crohn's disease, obstetric, irradiation, malignant, etc.).
- Other perineal fistulas (e.g. rectovaginal fistulas, pouch-vaginal fistulas, etc.).
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 PasteCollagen paste injection | Procedure or surgery | Collagen Paste |
| Mucosal advancementMucosal advancement flap | Procedure or surgery | Mucosal Advancement Flap |
Primary outcome
Clinical healing of Fistula-in-ano
Time frame: 1 year
Clinical healing of the fistula-in-ano
5 secondary outcomes
30-day morbidity
Time frame: 30 days
Quality of life score
Time frame: 1 year
Postoperative pain score
Time frame: 1 week
Faecal incontinence rate
Time frame: 1 year
Hospital readmission rate
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
Related trials for Fistula-in-ano
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
Recruiting
The Use of Electronic Bidets Compared to Water Rinsing After Surgery for Anal Fistula or Haemorrhoidal Disease: a Pilot Study
Anal Fistula Surgery, Anal Fistula
Active, not recruiting
A Study Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose
Fistula-in-ano, Draining Wound
Not yet recruiting
Seton Re-routing for High Perianal Fistula
High Perianal Fistula, Fistula-in-Ano
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen Paste and Mucosal advancement in people with Fistula-in-ano, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
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 7 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: looking for participants now, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaori Futaba, FRCS (35051495, kfutaba@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical healing of Fistula-in-ano (time frame: 1 year). 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 26 Apr 2024.