Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Management of idiopathic anal fistula using collagen: a prospective, randomised trial
Acronym
Study hypothesis
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
Ethics approval received from the East London and the City Research Ethics Committee in September 2004 (ref: P/03/870)
Study design
Prospective randomised single-blind controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Collagen
Primary outcome measure
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
Secondary outcome measures
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
Overall trial start date
01/09/2004
Overall trial end date
01/05/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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.
Recruitment start date
01/09/2004
Recruitment end date
01/05/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Homerton University Hospital NHS Foundation Trust
London
E9 6SR
United Kingdom
Sponsor information
Organisation
Queen Mary, University of London (UK)
Sponsor details
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
p.j.lunniss@qmul.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Local NHS Trusts (UK) - the trial was performed on NHS patients requring a surgical intervention at their local trusts
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Tissue Science Laboratories plc (UK) - donated Permacol® unconditionally
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/19863602
Publication citations
-
Results
Hammond TM, Porrett TR, Scott SM, Williams NS, Lunniss PJ, Management of idiopathic anal fistula using cross-linked collagen: a prospective phase 1 study., Colorectal Dis, 2011, 13, 1, 94-104, doi: 10.1111/j.1463-1318.2009.02087.x.