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ISRCTN
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ISRCTN67277406
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ClinicalTrials.gov identifier
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Public title
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Management of idiopathic anal fistula using collagen
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Scientific title
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Management of idiopathic anal fistula using collagen: a prospective, randomised trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Ethics approval
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Ethics approval received from the East London and the City Research Ethics Committee in September 2004 (ref: P/03/870)
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Study design
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Prospective randomised single-blind controlled study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Idiopathic anal fistulas deemed unsuitable for fistulotomy
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Participants - inclusion criteria
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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).
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Participants - exclusion criteria
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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.
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Anticipated start date
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01/09/2004
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Anticipated end date
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01/05/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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40
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Interventions
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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.
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Primary outcome measure(s)
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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.
2. Success of procedure assessed by symptom questionnaire and clinical examination at 3, 6, 9, 12 and 18-months post-intervention
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Secondary outcome measure(s)
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The 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
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Sources of funding
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1. Local NHS Trusts (UK) - the trial was performed on NHS patients requring a surgical intervention at their local trusts
2. Tissue Science Laboratories plc (UK) - donated Permacol® unconditionally
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Trial website
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Publications
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Contact name
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Mr
Peter
Lunniss
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Address
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Homerton University Hospital NHS Foundation Trust
Homerton Row
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City/town
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London
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Zip/Postcode
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E9 6SR
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Country
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United Kingdom
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Sponsor
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Queen Mary, University of London (UK)
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Address
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c/o Mr P J Lunniss
Centre for Academic Surgery
Institute of Cell & Molecular Science
Barts & The London NHS Trust
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City/town
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London
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Zip/Postcode
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1BB UK
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Country
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United Kingdom
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Email
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p.j.lunniss@qmul.ac.uk
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Sponsor website:
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http://www.qmul.ac.uk/
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Date applied
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20/06/2008
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Last edited
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13/08/2008
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Date ISRCTN assigned
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13/08/2008
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