Management of idiopathic anal fistula using collagen
| ISRCTN | ISRCTN67277406 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67277406 |
| Protocol serial number | N/A |
| Sponsor | Queen Mary, University of London (UK) |
| Funders | Local NHS Trusts (UK) - the trial was performed on NHS patients requring a surgical intervention at their local trusts, Tissue Science Laboratories plc (UK) - donated Permacol® unconditionally |
- Submission date
- 20/06/2008
- Registration date
- 13/08/2008
- Last edited
- 27/03/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Peter Lunniss
Scientific
Scientific
Homerton University Hospital NHS Foundation Trust
Homerton Row
London
E9 6SR
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised single-blind controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Management of idiopathic anal fistula using collagen: a prospective, randomised trial |
| Study objectives | Fibrin glue and porcine intestinal submucosa have been used as novel sphincter preserving techniques to heal anal fistulas, but the success of the former is highly variable, and widespread long term data are not available for the latter. The study aim was to assess the safety, feasibility and potential efficacy of another novel agent, cross-linked collagen, either as a solid implant or as fibres suspended in fibrin glue, to heal idiopathic anal fistulas. |
| Ethics approval(s) | Ethics approval received from the East London and the City Research Ethics Committee in September 2004 (ref: P/03/870) |
| Health condition(s) or problem(s) studied | Idiopathic anal fistulas deemed unsuitable for fistulotomy |
| Intervention | This is a randomised single-blind controlled study performed at two london (UK) hospitals, the Royal London Hospital and the Homerton University Hospital. Intervention 1: Solid Permacol® implant Intevention 2: Milled Permacol® fibres suspended in fibrin glue Permacol® (Tissue Science Laboratories plc) is a porcine derived acellular dermal sheet, predominately composed of Type I collagen (93 - 95%), with type III collagen and a small amount of elastin comprising the remainder. Sterile sheets 1.0 mm in thickness were used in this study. The alternative format is a 2.5 ml Permacol injection® (Tissue Science Laboratories plc), a 60% (wet weight/volume) suspension in saline of the cryogenically milled implant, with a defined particle size of 150 µm in diameter. Fibrin glue: The 1.0 ml Tisseel Kit® - Two Component Fibrin Sealant (Baxter Healthcare Ltd, UK) was employed. The implant was fashioned to the approximate dimensions of the fistula tract, and drawn into position using a suture, passed along a grooved fistula probe within the fistula tract. The fibre suspension was prepared as follows: 1 ml Permacol injection® was injected into a 1.5 ml sterile Eppendorf Biopur® pipette tip (Eppendorf UK Limited, UK), and centrifuged at 1,100 rpm for 5 minutes. The saline supernatant was discarded, and the residual collagen fibres re-suspended in 1.0 ml calcium chloride solution supplied with the Tisseel Kit®. The individual components of the Tisseel Kit® were mixed, warmed in a Fibrinotherm™ (Baxter AG, Austria) and were then drawn up into two syringes (syringe 1: fibrinogen and aprotinin; syringe 2: thrombin and collagen fibres suspended in calcium chloride solution), which were subsequently placed in a Duploject™ (Baxter AG) two-syringe clip, where they shared a common plunger. A plastic double-lumen Y-connector joined these two syringes. This apparatus was then attached to a 21-gauge cannula, passed along a grooved fistula probe in the fistula tract. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Collagen |
| Primary outcome measure(s) |
1. Safety of procedure, defined as no acute perineal sepsis or anal incontinence at 3 months post intervention. Assessed by symptom and continence questionnaires, clinical examination, anal manometry, and endoanal ultrasound. All peformed at 3 months post-intervention. |
| Key secondary outcome measure(s) |
The following were assessed by a patient questionnaire at 3-months post-intervention: |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | All patients, over 18-years, with an idiopathic anal fistula, under the care of a single surgeon, in whom fistulotomy was deemed unsuitable (on the basis of the fistula type and level, threat to continence or patient choice). |
| Key exclusion criteria | Patients with either clinical or radiological (magnetic resonance imaging) evidence of secondary tracts or acute sepsis were excluded from the trial until these had been eradicated, leaving a single primary tract. |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 01/05/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Homerton University Hospital NHS Foundation Trust
London
E9 6SR
United Kingdom
E9 6SR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
