A randomised controlled trial of Permacol® reinforcement of permanent stomas versus standard technique in reduction of parastomal hernia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31730807

Enrollment

300

Registered

2006-08-11

Start date

2006-07-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parastomal herniation Digestive System Parastomal herniation

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026