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Trial registered on ANZCTR


Registration number
ACTRN12622000128796p
Ethics application status
Not yet submitted
Date submitted
9/12/2021
Date registered
27/01/2022
Date last updated
27/01/2022
Date data sharing statement initially provided
27/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effects of prophylactic bioabsorbable mesh on incisional herniae formation following a reversal of ileostomy - A Prospective Randomized Open Blinded End-point study
Scientific title
Investigating the effects of prophylactic bioabsorbable mesh on incisional herniae formation following a reversal of ileostomy - A Prospective Randomized Open Blinded End-point study
Secondary ID [1] 305994 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Incisional hernia 324620 0
Condition category
Condition code
Surgery 322071 322071 0 0
Other surgery
Oral and Gastrointestinal 322440 322440 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
During the reversal of ileostomy procedure, the bowel will be anastamosed and placed back into the abdomen. The next step of the procedure is closure of the abdominal wall. The mesh will be implemented into the abdominal wall during this step. Note that the process of mesh placement and implementation is no different to any other incisional herniae repair. No specific training is required to use this mesh for this indication. All board certified general surgeons are qualified to close the abdomen and implement mesh in the process. Specifically for this mesh, since the mesh has already been in use for repair of herniae (including incisional herniae) in other settings, the surgeons involved have already been using this mesh. If, for any reason, there are any queries regarding the use of this mesh, a Bard representative is available to answer any questios although this is not likely to occur. The implementation of this mesh may prolong the original reversal of ileostomy procedure by 5-10 minutes (can vary from patient to patient, but unlikely). There will be multiple colorectal surgeons performinig this procedure at the institution. To ensure that the mesh is implemented in a consistent manner, there will be a meeting prior to the initiation of the study with all the colorectal surgeons involved in the study to review the methods of mesh implementation to minimize variation in their practices.
Intervention code [1] 322391 0
Prevention
Intervention code [2] 322392 0
Treatment: Devices
Comparator / control treatment
Comparator in this case are patients who are NOT getting the mesh during the reversal of ileostomy procedure
Control group
Active

Outcomes
Primary outcome [1] 329837 0
Radiologically Identified Incisional hernia at 12 months post-operation - This will be determined by CT scan at approximately 12 months post-operation. An independent radiologist will be involved to report the CT scan.
Timepoint [1] 329837 0
12 months post operation
Secondary outcome [1] 404012 0
Clinically detected hernia at the site of ileostomy reversal
The following steps will be followed during a clinical examination:
o The patient should be examined according to this scheme in both standing and lying positions
o The patient should perform either a Valsalva manoeuvre or a forceful cough, while the placing of a hand over the closed site
o A palpable fascial defect with or without protrusion of bowel or fat or a global weakness around the stoma scar without palpable fascial defect is recorded
o If in doubt, a second clinician will be consulted, and a consensus achieved
Timepoint [1] 404012 0
at each clinical review - 1,3,6,9,12 months post operation
Secondary outcome [2] 404013 0
Surgical reintervention rates - this will be based on data-linkage of operative records. Data will be collected to see how many participants have required reoperation
Timepoint [2] 404013 0
Surgical reintervention rates between the day of the operation and 12 months postoperation will be recorded. At each clinical visit i.e. 1,3,6,9,12 months, a record of whether the patient required reoperation will be recorded
Secondary outcome [3] 404014 0
Wound infections - At each clinical visit as specified previously, signs of wound infection will be recorded e.g. erythema/swelling/discharge/fluctuance/patient complaints and symptoms
Data linkage to medical records will be able to provide an indication of whether the patient has had wound infections based on the above symptoms.
Timepoint [3] 404014 0
Patient may present to the hospital at any point in time but clinically, the wound will be assessed at each clinical visit - 1,3,5,9,12 months post operation
Secondary outcome [4] 404015 0
Quality of life relating to the mesh and operative site
A EQ-5D Health Questionnaire will be used
Timepoint [4] 404015 0
At each clinical review - 1,3,6,9,12 months post operation
Secondary outcome [5] 404016 0
Cost-effectiveness of the use of the prophylactic mesh - Data linkage with medical records/services will be carried out. The number of representations/admissions/re-operations will be estimated.
Timepoint [5] 404016 0
At 12 months, patient data regarding representations/reoperations over the past 12 months after the initial operation will be reviewed.
Secondary outcome [6] 404628 0
Seroma formation
Clinically, a swelling, fluctuance without erythema, pain, fevers, wound discharge would indicate the presence of a clinically detectable seroma
Data linkage of medical records will also assist in identifying seroma formation
This may also be identified on imaging that the patient receives for other reasons/presentations e.g. patient has abdominal pains and presents to the emergency department and has incidental findings of seroma collection on a CT scan
Timepoint [6] 404628 0
Clinically assessed at each clinical visit - 1,3,6,9,12 months postoperation.
Secondary outcome [7] 405280 0
Pain (subjective)
A generic pain visual analgue scale will also be used
Timepoint [7] 405280 0
At each clinical review - 1,3,6,9,12 months post operation

Eligibility
Key inclusion criteria
1. Require an elective closure of an ileostomy or a colostomy.
2. The patient is able and willing to provide written informed consent for the study.
3. The patient is aged 18 years or over
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. They are taking part in another clinical study which is related to the surgical
procedure
2. They are allergic to mesh material.
3. They have a history of familial adenomatous polyposis (due to increased risk of
desmoid tumours)
4. The surgeon determines that a mesh repair will definitely be required due to large
parastomal hernia.
5. They are unable or unwilling to provide written 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21300 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 21301 0
John Flynn - Gold Coast Private Hospital - Tugun
Recruitment postcode(s) [1] 36172 0
4215 - Southport
Recruitment postcode(s) [2] 36173 0
4224 - Tugun

Funding & Sponsors
Funding source category [1] 310336 0
Commercial sector/Industry
Name [1] 310336 0
Bard/BD Australia
Country [1] 310336 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Blvd, Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 311467 0
None
Name [1] 311467 0
Address [1] 311467 0
Country [1] 311467 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 309996 0
Gold Coast Hospital and Health Service HREC
Ethics committee address [1] 309996 0
Office for Research Governance and Development
Level 2 Block E – Pathology and Education
1 Hospital Boulevard
Southport, QLD, 4215
Ethics committee country [1] 309996 0
Australia
Date submitted for ethics approval [1] 309996 0
09/02/2022
Approval date [1] 309996 0
Ethics approval number [1] 309996 0

Summary
Brief summary
Temporary ileostomies are formed in patients for multiple reasons. Some reasons include permitting bowel rest and promoting healing in patients with inflammatory bowel diseases as well as in patients who have received bowel resections and anastomoses for malignancies. These temporary ileostomies are often reversed at a later point. The site of the ileostomy closure is at risk of incisional hernia formation. These herniae can cause significant impairment in quality of life and often require re-operation for repairs. The high rate of re-operations can incur significant cost to the health system as well as expose patients to the risks of an operation. This project trials the use of a biodegradable mesh at the site of ileostomy closures in an attempt to reduce the rate of incisional herniae thereby, reducing the chances of operative complications as well as reducing a burden off the healthcare system. This project aims to trial the use of the mesh in a randomized study design (Prospective Randomized Open Blinded End-point study) to see if there is a change in the incidence of incisional herniae. Patients will be recruited at the time of the clinic appointment when they are being consented for the reversal of ileostomy procedure. At the time of the operation, the mesh would be implemented depending on whether the patient is in the interventional group. the patient would be followed up in the clinic and receive imaging to assess for whether incisional herniae have formed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116118 0
Dr Arun Naik
Address 116118 0
1 Hospital Blvd, Southport QLD 4215 and 14 Hill St,
Southport QLD 4215
Gold Coast University Hospital - Department of General Surgery
Country 116118 0
Australia
Phone 116118 0
+61411317194
Fax 116118 0
Email 116118 0
[email protected]
Contact person for public queries
Name 116119 0
Arun Naik
Address 116119 0
1 Hospital Blvd, Southport QLD 4215 and 14 Hill St,
Southport QLD 4215
Gold Coast University Hospital - Department of General Surgery
Country 116119 0
Australia
Phone 116119 0
+61 07 5530 0300
Fax 116119 0
Email 116119 0
[email protected]
Contact person for scientific queries
Name 116120 0
Justin Ng
Address 116120 0
1 Hospital Blvd, Southport QLD 4215 and 14 Hill St,
Southport QLD 4215
Gold Coast University Hospital - Department of General Surgery
Country 116120 0
Australia
Phone 116120 0
+61425313427
Fax 116120 0
Email 116120 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data collected from the research will be used to create an overall result. Patients who have developed hernia will be made aware of the diagnosis during clinical follow up but the data will not be published to be viewed by the public.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.