Condition category
Surgery
Date applied
10/09/2004
Date assigned
21/09/2004
Last edited
30/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes