Contact information
Type
Scientific
Primary contact
Mr John Griffith
ORCID ID
Contact details
Colorectal Surgical Unit
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
John.Griffith@bradfordhospitals.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PR700
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2004
Overall trial end date
31/12/2004
Reason abandoned
Lack of funding and participant recruitment issues
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant 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.
Recruitment start date
01/01/2004
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Colorectal Surgical Unit
Bradford
BD9 6RJ
United Kingdom
Sponsor information
Organisation
Tissue Science Laboratories plc (UK)
Sponsor details
Victoria House
Victoria Road
Aldershot
GU11 1EJ
United Kingdom
+ 44 (0) 1252 333002
ccurtis@tissuescience.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Tissue Science Laboratories plc (UK) is providing support for: clinical monitoring and associated costs; randomisation; statistical analyses and data management.
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