Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000221651
Ethics application status
Not yet submitted
Date submitted
17/02/2014
Date registered
3/03/2014
Date last updated
3/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized control trial evaluating the effects of biologic mesh for the prevention of parastomal hernias in patients undergoing colostomy, ileostomy, ileal, colonic or conduits.
Scientific title
A randomised controlled trial evaluating the effects of biologic mesh for the prevention of parastomal hernias in patients undergoing colostomy, ileostomy, ileal, colonic or conduits
Secondary ID [1] 284042 0
none
Universal Trial Number (UTN)
U1111-1153-0983
Trial acronym
RCT MESH STUDY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parastomal Hernias 291098 0
Patients undergoing colostomy, ileostomy, ileal, colonic or conduits 291217 0
Condition category
Condition code
Surgery 291442 291442 0 0
Surgical techniques
Oral and Gastrointestinal 291613 291613 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm: Surgisis (Registered Trademark) biologic mesh provided by Cook Biotech (Registered Trademark) will be inserted at the time of stoma formation.

It is not routine to insert mesh around the stoma. Mesh is used to repair parastomal hernias when they occur. This trial is to test whether prophylactic mesh at the time of stoma formation reduces the incidence of parastomal hernia. The intervention arm will undergo the insertion of biologic mesh placed intra-peritoneally around the stoma. The estimated extra time required to fixate the mesh around the stoma site would be approximately fifteen minutes. Aside from the procedure of a biologic mesh insertion, all patients in both the control and experimental groups will undergo the same preparation, care, and follow-up post surgery.
Intervention code [1] 288736 0
Prevention
Intervention code [2] 288828 0
Treatment: Surgery
Comparator / control treatment
Standard treatment will be given to the control group. The standard treatment is the formation of a permanent colostomy, ileostomy or ileal/colonic conduit without the use of biologic mesh.
Control group
Active

Outcomes
Primary outcome [1] 291424 0
Evaluate the development of parastomal hernia. Clinical and radiological evidence will be used to measure the primary outcome.
Timepoint [1] 291424 0
Patients will be followed up at 3, 6 12 months and 2 years post operation.
Secondary outcome [1] 306742 0
Complication rate of biologic mesh. Known complications for this procedure include infection, mesh erosion into the bowel or stoma creating a fistula, hematoma, recurrence and adhesions. Clinical and radiological evidence will be used to measure the secondary outcome.
Timepoint [1] 306742 0
Patients will be followed up 3, 6 12 months and 2 years post operation.
Secondary outcome [2] 306743 0
Costs associated with the procedure, length of stay, and any subsequent care related to the procedure (including the cost of repairing a hernia post procedure) will be collected.
Timepoint [2] 306743 0
Patients will be followed up immediately, 3, 6 12 months and 2 years post operation.

Eligibility
Key inclusion criteria
Age 18 years or older; undergoing colostomy, ileostomy, or ileal or colonic conduits; Patients fit for surgery; Informed consent attained.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age less than 18 years; patients who have previously had mesh inserted to the site of stoma formation or those who cannot have mesh inserted; no informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patients who come to Royal Prince Alfred (RPAH) hospital for bowel surgery, which includes the formation of a permanent stoma, ileostomy or colostomy and including ileal or colonic conduits, will be recruited for this study. The consultants involved in the trial are members of the colorectal team of RPAH. During consultation appointments at surgeons’ office hours, patients will be informed of the study. Allocation will be concealed using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculates the minimum number of participants in the control and experimental groups to be analyze whether the null hypothesis will be accepted or rejected. The literature currently indicates that there is a difference of 30% in rates of parastomal hernia. Given that this RCT is looking for statistical significance and not clinical significance, and that a more common two-sided test will be conducted, it was determined to use a test power of 80% (alpha equals .05). The required sample size for the control and experimental groups was calculated to be 38 patients each, and a total of 76 patients to be recruited for this study.
Patient age, sex, body mass index, details of previous abdominal surgery, and complications with mesh insertion will be recorded and analyzed to provide a overview of patient and operative characteristics related to the biologic mesh.
For objective (a) all patients will be monitored to evaluate for the development of clinical or radiological parastomal hernia. Using SPSS software, mean values and 95% confidence intervals will be calculated for normally distributed variables, and medians for non-normal data. Other descriptive statistics will be calculated. The fisher exact test and the Mann-Whitney U test will be used to determine statistical significance using a P < 0.05.
For objective (b) the mesh complication rates, descriptive statistics and rates will be calculated. These values will be compared with current values recorded in the current literature. And perhaps a comparison with synthetic mesh rates in the literature will be compared.
Finally, for objective (c) the cost effectiveness of the biologic mesh compared to no mesh will be calculated. During the course of data collection, costs associated with the procedure, length of stay, and any subsequent care related to the procedure (including the cost of repairing a hernia post procedure) will be collected. Subsequently, cost effectiveness will be calculated between control and experimental groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
Date of last participant enrolment
Anticipated
1/03/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2055 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 7745 0
2042 - Newtown

Funding & Sponsors
Funding source category [1] 288670 0
Self funded/Unfunded
Name [1] 288670 0
Country [1] 288670 0
Primary sponsor type
Individual
Name
Dr. Peter Lee
Address
RPA Medical Centre
Carillon Avenue, suite 415
Newtown NSW 2042
Country
Australia
Secondary sponsor category [1] 287378 0
None
Name [1] 287378 0
Address [1] 287378 0
Country [1] 287378 0
Other collaborator category [1] 277805 0
Individual
Name [1] 277805 0
Dr. Ian Choy
Address [1] 277805 0
RPA Medical Centre
Carillon Avenue, suite 415
Newtown NSW 2042
Country [1] 277805 0
Australia
Other collaborator category [2] 277806 0
Individual
Name [2] 277806 0
Dr. Cherry Koh
Address [2] 277806 0
RPA Medical Centre
Carillon Avenue, suite 415
Newtown NSW 2042
Country [2] 277806 0
Australia
Other collaborator category [3] 277807 0
Individual
Name [3] 277807 0
Dr. Kirk Austin
Address [3] 277807 0
RPA Medical Centre
Carillon Avenue, suite 415
Newtown NSW 2042
Country [3] 277807 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290520 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 290520 0
Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 290520 0
Australia
Date submitted for ethics approval [1] 290520 0
13/02/2014
Approval date [1] 290520 0
Ethics approval number [1] 290520 0

Summary
Brief summary
Parastomal hernias represent a significant morbidity for patients who require permanent stomas. Furthermore, they occur in up to 50-80% of these patients, resulting in a significant societal burden. The use of mesh is now standard surgical practice for the repair of all types of hernias, including parastomal hernias. However, repairing parastomal hernias can be very complex, and often carry their own complications such as enterotomies, prolonged ileus, recurrence, mesh infections, and fistula formation. As such, given the high rate of parastomal hernias, there has been increasing interest in using mesh at the time of stoma formation to prevent this complication.

Biologic mesh represents a promising solution to this problem. Biologic mesh has been shown to be an effective tool in hernia repair, without the infection and erosion complications associated with synthetic permanent meshes. A single initial study has been promising, demonstrating similarly low hernia rates as with synthetic meshes. However, questions still remain about whether the added costs associated with expensive biologic meshes can be offset by these potential reductions in patient morbidity.

This primary aim of this study is to determine the effectiveness of using biologic mesh at the time of formation of a permanent stoma in the prevention of parastomal hernias. The hypothesis is that the Surgisis (Registered Trademark) biologic mesh will reduce rates of parastomal hernia in patients. Secondary aims of this study include the assessment of any complications arising from this technique, as well as to assess the cost effectiveness of using biologic mesh over the study period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46070 0
Dr Peter Lee
Address 46070 0
RPA Medical Centre
100 Carillon Avenue, suite 415
Newtown NSW 2042
Country 46070 0
Australia
Phone 46070 0
+61- 414 250 057
Fax 46070 0
Email 46070 0
[email protected]
Contact person for public queries
Name 46071 0
Dr Peter Lee
Address 46071 0
RPA Medical Centre
100 Carillon Avenue, suite 415
Newtown NSW 2042
Country 46071 0
Australia
Phone 46071 0
+61- 414 250 057
Fax 46071 0
Email 46071 0
[email protected]
Contact person for scientific queries
Name 46072 0
Dr Peter Lee
Address 46072 0
RPA Medical Centre
100 Carillon Avenue, suite 415
Newtown NSW 2042
Country 46072 0
Australia
Phone 46072 0
+61- 414 250 057
Fax 46072 0
Email 46072 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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