A randomised controlled trial of Permacol® reinforcement of permanent stomas versus standard technique in reduction of parastomal hernia

ISRCTN	ISRCTN31730807
DOI	https://doi.org/10.1186/ISRCTN31730807
Protocol serial number	RL100
Sponsor	Tissue Science Laboratories plc (UK)
Funder	Tissue Science Laboratories plc (UK)

Submission date: 12/07/2006
Registration date: 11/08/2006
Last edited: 25/09/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Tina Jane Adams
Scientific

Tissue Science Laboratories
Victoria House
Victoria Road
Aldershot
Hampshire
GU11 1EJ
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PROPHECI
Study objectives	Our hypothesis is that reinforcing the stoma trephine with Permacola® when the stoma is being formed is superior to the standard technique without reinforcement in terms of preventing herniation, and the use of Permacol® is associated with less morbidity, infection and pain.
Ethics approval(s)	Approved by the Huntingdon Research Ethics Committee on 30/05/2006 (reference number: 06/Q0104/32).
Health condition(s) or problem(s) studied	Parastomal herniation
Intervention	We intend to randomise a cohort of patients who are undergoing permanent stoma formation for a variety of elective procedures between collagen mesh reinforcement of the stoma versus no mesh as control.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Permacola®
Primary outcome measure(s)	1. To determine the efficacy of Permacol® in reducing the incidence of parastomal hernia 2. To test whether the use of collagen mesh reinforcement is associated with lower rates of clinical herniation than no reinforcement. This will be evaluated at discharge and one, six, 12, 18 and 24 months post-operatively.
Key secondary outcome measure(s)	The secondary objectives of the study will be to determine differences in: 1. The radiological incidence of herniation as detected by Computerised Tomography (CT) scan and correlate this with the primary objective at 12 months 2. Complications associated with the technique used for the reinforcement. These will be evaluated at discharge and one, six, 12, 18 and 24 months post-operatively. 3. The handling characteristics, ease of insertion and suturing of the implant will be evaluated by the surgeon 4. Cost-benefit analysis comparing the cost of the reinforcement technique and the length of stay 5. Quality of life assessed using short-form-36 questionnaire (SF36) version two and EuroQol EQ-5D before and at one, six, 12, 18 and 24 months post-operatively
Completion date	01/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	300
Key inclusion criteria	1. Requirement of an elective permanent stoma due to bowel disease 2. Written informed consent 3. Must be aged 18 -100 years and agree to the randomised procedure 4. If of childbearing potential, must have given a negative pregnancy test
Key exclusion criteria	1. If participant is taking part in another clinical study, which directly relates to this study 2. Suffering from an untreated metabolic or systemic illness (e.g. diabetes or rheumatoid arthritis or any immunological disease) 3. A diagnosis of mentally limiting conditions such as Alzheimer's or mental retardation or is unable to understand all study requirements 4. Is allergic to any porcine or collagen products 5. Has any indication of a Methicillin-Resistant Staphylococcus Aureus (MRSA) infection 6. Any indication of abdominal wall sepsis
Date of first enrolment	01/07/2006
Date of final enrolment	01/08/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Tissue Science Laboratories

Hampshire
GU11 1EJ
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