Condition category
Digestive System
Date applied
20/06/2008
Date assigned
13/08/2008
Last edited
27/03/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Peter Lunniss

ORCID ID

Contact details

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

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 measures

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

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

http://www.qmul.ac.uk/

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/19863602

Publication citations

  1. 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.

Additional files

Editorial Notes