Condition category
Digestive System
Date applied
04/05/2011
Date assigned
13/05/2011
Last edited
20/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Charles Knowles

ORCID ID

Contact details

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
+44 (0)20 7882 8752
c.h.knowles@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol Number 4.0

Study information

Scientific title

A randomised controlled trial of Stapled Mesh stomA Reinforcement Technique (SMART) versus standard technique to assess effect on parastomal herniation

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

West London Research Ethics Committee, 19/01/2011, ref: 10/H0706/92

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

02/04/2011

Overall trial end date

30/09/2020

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

116

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

Germany, Spain, United Kingdom

Trial participating centre

Academic Surgical Unit
The Royal London Hospital Whitechapel Road
London
E1 1BB
United Kingdom

Trial participating centre

Whipps Cross University Hospital
Whipps Cross Rd
London
E11 1NR
United Kingdom

Trial participating centre

The Royal Free NHS Foundation Trust
Barnet and Chase Farm Hospital 127 The Ridgeway
Enfield
EN2 8JL
United Kingdom

Trial participating centre

The Royal United Hospital NHS Foundation Trust
Combe Park
Bath
BA1 3NG
United Kingdom

Trial participating centre

Hospital de Sagunto
Unidad de Coloproctología Servicio de Cirugía General Secretaría y Cajal
Sagunto (Valencia)
s/n 46520
Spain

Trial participating centre

Klinikum Chemnitz
Altendorf Flemmingstraße 2
Chemnitz
09116
Germany

Trial participating centre

Diakoniekrankenhaus Chemnitzer Land
Limbacher Str. 19
Hartmannsdorf
09232
Germany

Trial participating centre

Rotkreuzklinikum München
Nymphenburger Str. 163
München
80634
Germany

Sponsor information

Organisation

Queen Mary, University of London (UK)

Sponsor details

c/o Sally Burtles
Joint Research and Development Office
Queen Mary Innovation Centre
Lower Ground Floor
5 Walden Street
London
E1 2EF
United Kingdom
+44 (0)20 7882 7250
sponsorsrep@bartshealth.nhs.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Ileostomy and Internal Pouch Support Group (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Enteric Healthcare Technology Co-operative

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

Intention to publish date

30/09/2021

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.