A randomised controlled study to compare the use of Permacol™ for repair of parastomal hernias with current treatment with either synthetic mesh or primary suture repair

ISRCTN	ISRCTN79431254
DOI	https://doi.org/10.1186/ISRCTN79431254
Secondary identifying numbers	PR700

Submission date: 10/09/2004
Registration date: 21/09/2004
Last edited: 30/06/2011

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Surgery

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

Mr John Griffith
Scientific

Colorectal Surgical Unit
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Email	John.Griffith@bradfordhospitals.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Parastomal hernias are protrusions of the abdominal viscera adjacent to a stoma. Most parastomal hernias develop in the first few years after stoma formation but there is an on-going risk, especially in patients with risk factors such as obesity and raised intra-abdominal pressure. Parastomal hernias may be asymptomatic but they frequently cause difficulty with fixation of the stoma appliance resulting in leakage. There is also a risk of strangulation, which can cause intestinal obstruction.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Parastonal hernia
Intervention	There is no standard method to repair parastomal hernias. Some surgeons use primary repair which involves suturing the patient's tissue directly with suture material, whereas others prefer to use a surgical implant of varying types to strengthen the repair. These repairs are not without problems. Permacol™ surgical implant is a flat sheet of porcine dermal collagen. It carries the class III CE mark and FDA clearance and is fully licensed for permanent implantation into humans. It has been successfully implanted in over 75,000 patients worldwide since 1998, in a variety of surgical procedures. Permacol™ has already been used to successfully repair parastomal hernias. This study will investigate the feasibility of implanting a sheet of Permacol™ around the stoma to repair the parastomal hernia and compare the results with the preferred method of each hospital.
Intervention type	Procedure/Surgery
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2004
Completion date	31/12/2004
Reason abandoned (if study stopped)	Lack of funding and participant recruitment issues

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	Patients must have a symptomatic parastomal hernia; be aged over 18 (or the country applicable age of consent); if of child-bearing age must have given a negative pregnancy test; give written informed consent; agree to be randomised.
Key exclusion criteria	Patients must not be taking part in another clinical study; not be suffering from an UNTREATED metabolic or systemic illness (e.g. diabetes or rheumatoid arthritis); not have a diagnosis of mentally limiting conditions such as Alzheimer's or mental retardation or be unable to understand all study requirements; not be allergic to any porcine or collagen products.
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Colorectal Surgical Unit

Bradford
BD9 6RJ
United Kingdom

Sponsor information

Tissue Science Laboratories plc (UK)
Industry

Victoria House
Victoria Road
Aldershot
GU11 1EJ
United Kingdom

Phone	+ 44 (0) 1252 333002
Email	ccurtis@tissuescience.com
"ROR"	https://ror.org/020hbh524

Funders

Funder type

Industry

Tissue Science Laboratories plc (UK) is providing support for: clinical monitoring and associated costs; randomisation; statistical analyses and data management.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan