Plain English Summary
Background and study aims
Parastomal herniation (when the bowel pushes through the muscles surrounding an artificial opening called a stoma and this causes a bulge under the skin) is a common complication following formation of a stoma, occurring in approximately 50% of patients. Although many patients do not suffer from the hernia, approximately 10% require surgical hernia repair, as hernias can cause pain, bag failure, impaired body image and serious/life threatening problems such as bowel obstruction and strangulation of the bowel. Surgical repair of a parastomal hernia is a considerable operation, with its own risks and a high rate of failure (approximately 50%). A technique of using a biological mesh to strengthen the stoma site is currently under investigation and results have shown that reinforcement of the abdominal wall at the stoma site does reduce the incidence of parastomal hernia. This mesh technique is a very costly procedure, so we are aiming to produce the same level of reinforcement of the stoma site using a sutured technique, which will have the same benefits but be less expensive. Comparing both techniques is the aim of this study.
Who can participate?
All patients over the age of 18, who are not pregnant and require a stoma to be formed for bowel disease as an elective procedure. A total of 100 patients are going to be recruited, with 50 undergoing formation of the stoma by the standard technique and the other 50 undergoing formation of the stoma by the Sutured Trephine Annular Reinforcement Technique (START).
What does the study involve?
The patients will be informed about the trial and given a patient information sheet by their lead consultant in outpatients when they are listed for surgery. They will then be seen by a member of the research team prior to surgery, so that any questions can be asked and consent can be gained if the patient agrees to trial entry. The patients are then randomly allocated to one of the two techniques (by use of sealed envelopes which are opened just prior to the formation of the stoma in theatre).
Patients who have their stomas reversed will have the occurrence of any parastomal hernia noted by the consultant surgeon during the reversal procedure. For those patients that do not have their stomas reversed, they will be invited to attend outpatients to have the presence of any parastomal hernia assessed clinically by a member of the research team, who does not which technique has been used.
All patients will be sent Quality of Life questionnaires at 6 months and 30 months.
What are the possible benefits and risks of participating?
There is a risk that there will be no difference to the patients chances of forming a hernia whatever technique is used to form the stoma. However, there is also a chance that one technique may have a lower hernia rate than the other and this may benefit the patient in terms of stoma related complications and stoma function. The process of placing a reinforcing stitch into the stoma hole will take about 10 minutes, so the patients operation may be very slightly longer. However, this should not represent any significant additional risk to the patients health. Sometimes the stoma hole can be a bit tight and this can cause the stoma not to work properly. Very occasionally this requires a further operation to sort it out. However, this is a risk of standard stoma formation and placing the stitch is unlikely to increase this risk.
Where is the study run from?
This study is taking place in Castle Hill Hospital, Hull (UK).
When is the study starting and how long is it expected to run for?
The study started in September 2012 and is anticipated to run for a total of 30 months after the recruitment of the 100th patient (approximately September 2017).
Who is funding the study?
Spire Hospital and University of Hull (UK). The only additional costs incurred during this study are staffing costs. The study is run by research fellows who are already in funded jobs at the Spire Hospital.
Who is the main contact?
Mr Iain Andrew Hunter
Iain.hunter@hey.nhs.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ASU-IAH-2012.1 START
Study information
Scientific title
A randomised controlled trial of Sutured Trephine Annular Reinforcement versus standard Technique to assess effect on parastomal herniation
Acronym
START
Study hypothesis
That stoma formation using the sutured trephine annular reinforcement technique leads to reduced parastomal hernia rates.
Ethics approval
NRES Committee Yorkshirew and The Humber - Sheffield, 23/04/2012, ref: 12/YH/0127
Study design
Randomised prospective double-blinded 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 hernias/stoma formation/colorectal surgery
Intervention
Stoma formation via standard trephine formation
Stoma formation via sutured trephine annular reinforment technique
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
Parastomal hernia rates at 30 months, or at time of stoma reversal
Secondary outcome measures
1. Stoma related complications requiring hospital admission
2. Changes in quality of life assessments over a 30 month period
Overall trial start date
01/09/2012
Overall trial end date
01/03/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Participants must:
1. Require an elective stoma due to bowel disease
2. Have given written informed consent
3. Be aged 18 or 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
100
Participant exclusion criteria
Patients must not:
1. Be taking part in another clinical trial which directly correlates to this one
2. Have abdominal wall sepsis
3. Be pregnant
4. Be unable to consent to participation
5. Be undergiong refashioning (but not transposition) of the stoma
Recruitment start date
01/09/2012
Recruitment end date
01/03/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Castle Hill Hospital
Cottingham
HU16 5JQ
United Kingdom
Sponsor information
Organisation
Hull and East Yorkshire Hospitals NHS Trust (UK)
Sponsor details
R & D Department
Office 6
2nd floor Daisy building
Castle Hill Hospital
Cottingham
HU16 5JQ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Spire Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Hull (UK)
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
Basic results (scientific)
Publication list