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 |
| Secondary identifying numbers | RL100 |
- 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
Scientific
Tissue Science Laboratories
Victoria House
Victoria Road
Aldershot
Hampshire
GU11 1EJ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Permacola® |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/07/2006 |
| Completion date | 01/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Tissue Science Laboratories
Hampshire
GU11 1EJ
United Kingdom
GU11 1EJ
United Kingdom
Sponsor information
Tissue Science Laboratories plc (UK)
Industry
Industry
Victoria House
Victoria Road
Aldershot
Hampshire
GU11 1EJ
United Kingdom
| Website | http://www.tissuescience.com/ |
|---|---|
"ROR" |
https://ror.org/020hbh524 |
Funders
Funder type
Industry
Tissue Science Laboratories plc (UK)
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 |
