Management of idiopathic anal fistula using collagen

ISRCTN ISRCTN67277406
DOI https://doi.org/10.1186/ISRCTN67277406
Secondary identifying numbers N/A
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

Homerton University Hospital NHS Foundation Trust
Homerton Row
London
E9 6SR
United Kingdom

Study information

Study designProspective randomised single-blind controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleManagement of idiopathic anal fistula using collagen: a prospective, randomised trial
Study objectivesFibrin 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) studiedIdiopathic anal fistulas deemed unsuitable for fistulotomy
InterventionThis 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Collagen
Primary outcome measure1. 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.
2. Success of procedure assessed by symptom questionnaire and clinical examination at 3, 6, 9, 12 and 18-months post-intervention
Secondary outcome measuresThe following were assessed by a patient questionnaire at 3-months post-intervention:
1. Time taken for perineal wound to heal
2. Time taken to return to work
Overall study start date01/09/2004
Completion date01/05/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Key inclusion criteriaAll 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 criteriaPatients 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 enrolment01/09/2004
Date of final enrolment01/05/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Homerton University Hospital NHS Foundation Trust
London
E9 6SR
United Kingdom

Sponsor information

Queen Mary, University of London (UK)
University/education

c/o Mr P J Lunniss
Centre for Academic Surgery
Institute of Cell & Molecular Science
Barts & The London NHS Trust
London
1BB UK
United Kingdom

Email p.j.lunniss@qmul.ac.uk
Website http://www.qmul.ac.uk/
ROR logo "ROR" https://ror.org/026zzn846

Funders

Funder type

Government

Local NHS Trusts (UK) - the trial was performed on NHS patients requring a surgical intervention at their local trusts

No information available

Tissue Science Laboratories plc (UK) - donated Permacol® unconditionally

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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