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Trial registered on ANZCTR


Registration number
ACTRN12611001252909
Ethics application status
Approved
Date submitted
30/11/2011
Date registered
6/12/2011
Date last updated
6/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Parastomal Hernia Prevention Trial
Scientific title
A randomised, controlled multicentre trial to assess the safety and efficacy of prophylactic mesh in the prevention of parastomal herniae.
Secondary ID [1] 273549 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parastomal Hernia 279294 0
Permanant colostomy 279295 0
Condition category
Condition code
Cancer 279490 279490 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Surgery 279491 279491 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mesh Intervention Procedure:
Subjects in this arm of the study will have mesh permanently implanted at the stoma site at the time of their surgery. The procedure duration will differ between patients depending on the circumstances of, and indications for, the surgery. The stoma formation will be performed as follows:
1. Dissect away a section of peritoneum and posterior rectus sheath on the side of the colostomy from the posterior aspect of the rectus abdominus muscle with the centre of the superior-inferior aspect of this area at the level of the marked colostomy trephine site.
2. Place a piece of 15cm x 15cm mesh in the space.
3. Secure the lateral corners of the mesh to the lateral abdominal wall musculature with a permanent suture.
4. Make the trephine at the marked site using a circular skin incision and deepen through abdominal wall fat to the fascia. Make a cruciate incision in the anterior rectus sheath, split the rectus abdominus muscle longitudinally.
5. Cut a circle in the centre of the mesh and the peritoneum of a size just adequate to allow easy passage of the colon through the mesh and then the abdominal wall.
6. Deliver the colon through the trephine site to the skin.
7. Close fascia.
8. Irrigate wound.
9. Close the midline wound skin.
10. Apply a dressing to the midline wound.
11. Mature the colostomy using dissolvable sutures.
12. Apply the colostomy bag.
Intervention code [1] 283816 0
Treatment: Surgery
Comparator / control treatment
Standard Procedure:
Subjects in this arm of the study will not have any mesh implanted at the stoma site at the time of their surgery. The procedure duration will differ between patients depending on the circumstances of, and indications for, the surgery. The stoma formation will be performed as follows:
1. Make the trephine at the marked site using a circular skin incision and deepen through abdominal wall fat to the fascia. Make a cruciate incision in the anterior rectus sheath, split the rectus abdominus muscle longitudinally and open the peritoneum.
2. Deliver the colon through the trephine site to the skin.
3. Close fascia.
4. Irrigate wound.
5. Close the midline wound skin.
6. Apply a dressing to the midline wound.
7. Mature the colostomy using dissolvable sutures.
8. Apply the colostomy bag.
Control group
Active

Outcomes
Primary outcome [1] 286054 0
The formation of clinically-apparent parastomal herniae.
Assessment:
Clinical assessment of stoma site.
Timepoint [1] 286054 0
6 weeks and 6, 12, 36 and 120 months postoperatively.
Primary outcome [2] 286055 0
The formation of radiologically-apparent parastomal herniae.
Assessment:
CT scan of abdomen
Timepoint [2] 286055 0
12, 36 and 120 months postoperatively.
Secondary outcome [1] 295047 0
Duration of operating time.
Assessments:
1. Duration between knife-to-skin and last suture.
2. Duration between commencing stoma formation and attachment of colostomy bag.
Timepoint [1] 295047 0
At the time of surgery.
Secondary outcome [2] 295048 0
Duration of hospital length of stay.
Assessment:
Number of days from time of surgery until discharge from hospital.
Timepoint [2] 295048 0
At discharge from hospital.
Secondary outcome [3] 295049 0
Complications, including stomal stricture, stoma dehiscence, wound dehiscence, stomal fistula, small bowel obstruction, wound infection, pelvic abscess, or incisional hernia.
Assessment:
1. Clinical assessment
2. X-ray(where necessary to confirm diagnosis)
3. Blood tests (where necessary to confirm diagnosis)
Timepoint [3] 295049 0
6 weeks and 6, 12, 36 and 120 months postoperatively.
Secondary outcome [4] 295050 0
Readmission to hospital.
Assessment:
1. Medical record review
Timepoint [4] 295050 0
Within 28 days postoperatively.
Secondary outcome [5] 295051 0
Re-operation.
Assessment:
1. Medical record review
Timepoint [5] 295051 0
6 weeks and 6, 12, 36 and 120 months postoperatively.
Secondary outcome [6] 295052 0
New or recurrent malignancy.
Assessment:
1. Clinical assessment
2. CT scan (where necessary to confirm diagnosis)
3. Blood tests (where necessary to confirm diagnosis)
Timepoint [6] 295052 0
6 weeks and 6, 12, 36 and 120 months postoperatively.
Secondary outcome [7] 295053 0
All cause mortality
Assessment:
1. Medical record review
Timepoint [7] 295053 0
6 weeks and 6, 12, 36 and 120 months postoperatively.

Eligibility
Key inclusion criteria
Subjects requiring elective admission for an open colon or colorectal resection to include the formation of a permanent end colostomy. The procedures will include the following:
a. Abdomino-perineal resection of the rectum;
b. Rectosigmoidectomy (Hartmann’s procedure); or
c. Formation of end colostomy for incontinence.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects who do not consent to participate in the trial or are unable to provide informed consent. This may include patients who are not able to understand or follow the trial protocol because English is not their first language, or because of medical or psychiatric conditions.
2. Subjects who are having emergency operations.
3. Subjects with grossly disseminated disease, who are not expected to live longer than 12 months.
4. Subjects in whom there is significant spillage of faecal contents in the area of the wound or the stoma site during the procedure.
5. Subjects with inflammatory bowel disease, including Crohn's disease or irritable bowel syndrome.
6. Subjects with concurrent infection at the operating site or the stoma site at the time of the surgery.
7. Females who are pregnant or breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation at 1:1 ratio.
Permuted block randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284288 0
Self funded/Unfunded
Name [1] 284288 0
Address [1] 284288 0
Country [1] 284288 0
Primary sponsor type
Hospital
Name
The Lyell McEwin Hospital
Address
Haydown Road
Elizbaeth Vale SA 5112
Country
Australia
Secondary sponsor category [1] 283240 0
None
Name [1] 283240 0
Address [1] 283240 0
Country [1] 283240 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286249 0
Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 286249 0
Ground Floor, Basil Hetzel Institute for Medical Research
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Ethics committee country [1] 286249 0
Australia
Date submitted for ethics approval [1] 286249 0
25/09/2006
Approval date [1] 286249 0
19/04/2007
Ethics approval number [1] 286249 0
2006103
Ethics committee name [2] 286250 0
Human Research Ethics Committee (RAH)
Ethics committee address [2] 286250 0
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Ethics committee country [2] 286250 0
Australia
Date submitted for ethics approval [2] 286250 0
20/07/2006
Approval date [2] 286250 0
08/09/2006
Ethics approval number [2] 286250 0
60714

Summary
Brief summary
This is a prospective, single-blind, randomised, parallel-group, controlled proof-of-concept study to evaluate the safety and efficacy of the implantation of a prophylactic mesh at the time of the formation of a permanent stoma, compared to standard stoma formation, at preventing the incidence of herniae formation or the risk of stoma and non-stoma related complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33465 0
Address 33465 0
Country 33465 0
Phone 33465 0
Fax 33465 0
Email 33465 0
Contact person for public queries
Name 16712 0
Mr Andrew Luck
Address 16712 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112
Country 16712 0
Australia
Phone 16712 0
+61 (0) 8 8182 9000
Fax 16712 0
Email 16712 0
andrew.luck@health.sa.gov.au
Contact person for scientific queries
Name 7640 0
Mr Andrew Luck
Address 7640 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112
Country 7640 0
Australia
Phone 7640 0
+61 (0) 8 8182 9000
Fax 7640 0
Email 7640 0
andrew.luck@health.sa.gov.au

No data has been provided for results reporting
Summary results
Not applicable