Stapled mesh stoma reinforcement technique (SMART) to prevent parastomal herniation
| ISRCTN | ISRCTN94943190 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94943190 |
| Secondary identifying numbers | Protocol Number 4.0 |
- Submission date
- 04/05/2011
- Registration date
- 13/05/2011
- Last edited
- 04/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Digestive System
Plain English Summary
Background and study aims
A stoma is an opening on the outer surface of the abdomen that is surgically created after removal of part of the bowel or urinary system to divert urine or feces into an external pouch. A parastomal hernia occurs when a weakness in the abdominal wall muscles allows tissue to protrude out, creating a bulge around the stoma. The aim of this study is to find out whether creation of the stoma trephine by a stapling technique together with mesh reinforcement can simplify the reinforcement procedure and reduce the incidence of parastomal herniation compared to standard techniques, whether the stoma is constructed by open or laparoscopic (keyhole) techniques.
Who can participate?
Patients aged 18 and over who require a permanent stoma due to bowel disease
What does the study involve?
Participants are randomly allocated into two groups. One group undergoes standard stoma formation with no reinforcement. The other group receives a stapled trephine with mesh reinforcement. This involves use of a circular stapling device to form and simultaneously reinforce the abdominal wall stoma with mesh. The rate of parastomal herniation is assessed at 24 months after surgery.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
1. The Royal London Hospital (UK)
2. Whipps Cross University Hospital (UK)
3. The Royal Free NHS Foundation Trust (UK)
4. The Royal United Hospital NHS Foundation Trust (UK)
5. Hospital de Sagunto (Spain)
6. Klinikum Chemnitz (Germany)
7. Diakoniekrankenhaus Chemnitzer Land (Germany)
8. Rotkreuzklinikum München (Germany)
When is the study starting and how long is it expected to run for?
April 2011 to September 2020
Who is funding the study?
1. Ileostomy and Internal Pouch Support Group (UK)
2. Enteric Healthcare Technology Co-operative
Who is the main contact?
Prof. Charles Knowles
c.h.knowles@qmul.ac.uk
Contact information
Scientific
National Bowel Research Centre
Blizard Institute of Cell and Molecular Science
Barts and The London School of Medicine and Dentistry
Abernethy Building, 1st Floor
2 Newark Street
Whitechapel
London
E1 2AT
United Kingdom
| Phone | +44 (0)20 7882 8752 |
|---|---|
| c.h.knowles@qmul.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised controlled trial of Stapled Mesh stomA Reinforcement Technique (SMART) versus standard technique to assess effect on parastomal herniation |
| Study acronym | SMART |
| Study hypothesis | Creation of the stoma trephine by a stapling technique together with mesh reinforcement can simplify the reinforcement procedure and reduce the incidence of parastomal herniation compared to standard techniques, irrespective whether the stoma is constructed by open or laparoscopic techniques. |
| Ethics approval(s) | West London Research Ethics Committee, 19/01/2011, ref: 10/H0706/92 |
| Condition | Parastomal herniation |
| Intervention | Patients who require permanent colostomy or ileostomy will be randomised into two groups: 1. Standard stoma formation, no reinforcement 2. Stapled trephine with mesh reinforcement. This involves use of a circular stapling device (Compact , Frankenman) to form and simultaneously reinforce the abdominal wall stoma with mesh |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 02/04/2011 |
| Overall study end date | 30/09/2020 |
| Reason abandoned (if study stopped) | Protocol violations |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 116 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 02/04/2011 |
| Recruitment end date | 01/02/2018 |
Locations
Countries of recruitment
- England
- Germany
- Spain
- United Kingdom
Study participating centres
Whitechapel Road
London
E1 1BB
United Kingdom
London
E11 1NR
United Kingdom
127 The Ridgeway
Enfield
EN2 8JL
United Kingdom
Bath
BA1 3NG
United Kingdom
Servicio de Cirugía General
Secretaría y Cajal
Sagunto (Valencia)
s/n 46520
Spain
Flemmingstraße 2
Chemnitz
09116
Germany
Hartmannsdorf
09232
Germany
München
80634
Germany
Sponsor information
University/education
c/o Sally Burtles
Joint Research and Development Office
Queen Mary Innovation Centre
Lower Ground Floor
5 Walden Street
London
E1 2EF
England
United Kingdom
| Phone | +44 (0)20 7882 7250 |
|---|---|
| sponsorsrep@bartshealth.nhs.uk | |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Charity
No information available
No information available
Results and Publications
| Intention to publish date | 30/09/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan |
Editorial Notes
04/09/2020: The study was stopped due to protocol violations.
23/02/2018: Plain English summary added.
20/09/2017: The following changes were made to the trial record:
1. The overall trial end date was changed from 02/04/2016 to 30/09/2020.
2. The recruitment end date was changed from 02/04/2016 to 01/02/2018.
3. Germany and Spain were added to the countries of recruitment.
4. Frankenman International (Hong Kong) was removed and Enteric Healthcare Technology Co-operative was added to the list of funders.
