Parastomal herniation Digestive System Hernia
Conditions
Interventions
Patients who require permanent colostomy or ileostomy will be randomised into two groups:
1. Standard stoma formation, no reinforcement
2. Stapled trephine with mesh re
Sponsors
Queen Mary, University of London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 20/09/2017: 1. Require an elective permanent stoma due to benign or malignant bowel disease 2. Have given written informed consent 3. Be aged 18 and over 4. Able to read and understand English (or language of country of research site) 5. Agree to the randomised procedure 6. If of childbearing potential, must have given a negative pregnancy test 7. Negative Methicillin-resistant Staphylococcus aureus (MRSA) screening test Previous inclusion criteria: 1. Require an elective permanent stoma due to bowel disease 2. Have given written informed consent 3. Be aged 18 (or be of the age of consent in the country applicable) and over 4. Agree to the randomised procedure 5. If of childbearing potential, must have given a negative pregnancy test
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 20/09/2017: 1. Is taking part in another clinical study which directly relates to this study 2. Stoma re-siting 3. Has a history of parastomal herniation. 4. Is suffering from an uncontrolled metabolic or systemic illness (e.g. diabetes or rheumatoid arthritis or any immunological disease) as determined by their responsible physician/surgeon. 5. A diagnosis of mentally limiting conditions such as Alzheimer’s or intellectual disabilty 6. Has clostridium difficile infection resulting in pseudomembraneous colitis 7. Has abdominal wall sepsis Previous exclusion criteria: 1. Is taking part in another clinical study which directly relates to this study 2. If a patient is taking part in a non-related study, the investigator should discuss with the management team 3. Has a history of parastomal herniation. Such patients will not be randomised but will be offered stoma resiting and mesh reinforcement and followed-up prospectively according to this protocol. 4. Is suffering from an untreated metabolic or systemic illness (e.g. diabetes or rheumatoid arthritis or any immunological disease) 5. A diagnosis of mentally limiting conditions such as Alzheimer?'s or mental retardation or is unable to understand all study requirements 6. Has Methicillin-resistant Staphylococcus aureus (MRSA) or Clostridium difficile infection 7. Has abdominal wall sepsis 8. Pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures: The rate of clinically evident parastomal herniation at 24 months post operatively, as assessed by a local investigator blinded to treatment allocation Previous primary outcome measures: 1. The rate of clinical herniation evaluated clinically at discharge and at 1, 12, 24 and 60 months post operatively 2. The radiological incidence of herniation detected by computerised tomography (CT) scan at 12, 24 and 60 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures: 1. The rate of clinically evident parastomal herniation evaluated at all other time points (annually up to a maximum of 5 years), as assessed by a local investigator blinded to treatment allocation 2. The rate of herniation as detected by computerised tomography (CT) scan or other radiological examinations of the abdomen, evaluated at 12 and 24 months after surgery 3. Harms including perioperative morbidity (assessed clinically at hospital discharge and at 6 weeks), 30-day mortality and long-term complications 4. The ease of the technique compared with the standard technique, evaluated by bespoke surgeon questionnaire at surgery 5. Quality of life assessed using EuroQol EQ-5D-3L questionnaires preoperatively and at 12 and 24 months post-operatively Previous secondary outcome measures: 1. Complications associated with the techniques used for the procedures, evaluated at discharge and at 1, 12, 24 and 60 months post operatively 2. The ease of the technique compared with the standard technique 3. Cost/benefit analysis comparing the cost of the stapled reinforcement technique with Vypro® mesh to the standard technique 4. Quality of life assessed using SF36 version 2 and EuroQol EQ-5D questionnaires preoperatively and at 1, 12, 24 and 60 months post-operatively | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed