Condition category
Digestive System
Date applied
04/05/2011
Date assigned
13/05/2011
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Norman Williams

ORCID ID

Contact details

Academic Surgical Unit
Centre for Digestive Disease
Blizard Institute of Cell and Molecular Science
Barts and The London School of Medicine and Dentistry
3rd Floor Alexandra Wing
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
+44 (0)20 7882 8752
n.s.williams@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol Number 3

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, 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 below to request a patient information sheet

Condition

Parastomal Herniation

Intervention

1. Patients who require permanent colostomy or ileostomy will be randomised into two groups:
1.1. Standard stoma formation, no reinforcement
1.2. Stapled trephine with mesh reinforcement
2. Utilisation 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

1. To test whether the use of a stapled trephine with prophylactic mesh reinforcement is associated with lower rates of clinical herniation than no reinforcement
2. This will be evaluated clinically at discharge and at 1, 12, 24 and 60 months post operatively
3. The radiological incidence of herniation as detected by computerised tomography (CT) scan and correlate this with the clinical findings at 12, 24 and 60 months after surgery

Secondary outcome measures

1. To measure differences in complications associated with the techniques used for the procedures. These will be evaluated at discharge and at 1, 12, 24 and 60 months post operatively
2. To assess 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 assessment 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

02/04/2016

Reason abandoned

Eligibility

Participant 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

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

02/04/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Surgical Unit
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Queen Mary, University of London (UK)

Sponsor details

c/o Mr Gerry Leonard
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
gerry.leonard@bartsandthelondon.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

Frankenman International (Hong Kong)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes