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 |
| Protocol serial number | PR700 |
| Sponsor | Tissue Science Laboratories plc (UK) |
| Funder | Tissue Science Laboratories plc (UK) is providing support for: clinical monitoring and associated costs; randomisation; statistical analyses and data management. |
- 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
Scientific
Colorectal Surgical Unit
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
| John.Griffith@bradfordhospitals.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 |
| 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
- United Kingdom
- England
Study participating centre
Colorectal Surgical Unit
Bradford
BD9 6RJ
United Kingdom
BD9 6RJ
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 |
