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Trial registered on ANZCTR


Registration number
ACTRN12618000542291
Ethics application status
Approved
Date submitted
19/03/2018
Date registered
11/04/2018
Date last updated
21/03/2019
Date data sharing statement initially provided
21/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Stoma closure using bio-absorbable reinforcement (SCUBAR).
Scientific title
Prevention of incisional hernia after stoma closure using a synthetic bio-absorbable tissue reinforcement.
Secondary ID [1] 294380 0
Nil known
Universal Trial Number (UTN)
U1111-1211-1072
Trial acronym
SCUBAR
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Incisional hernia after stoma reversal or resiting 307108 0
Condition category
Condition code
Surgery 306219 306219 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: At the time of stoma reversal or resiting, the intervention group will have Gore BioA synthetic absorbable tissue reinforcement placed by the operating surgeon in either the pre-peritoneal (retro-rectus) space or deep to the anterior fascia of the abdominal wall at the site of the stoma reversal. The recto-rectus position is preferred. If Gore BioA is to be placed in the retro-rectus position, after developing the pre-peritoneal space, the peritoneum will be closed with 2-0 or 3-0 PGA sutures at the discretion of the surgeon. Ideally the space created should be adequate to place the Gore™ BioA™ FS0808 (8 x 8cm). The Gore BioA is to be secured with 4 x 3-0 polydioxanone sutures. Suture closure of the fascia will be performed with interrupted 0 polydioxanone sutures. The additional time required to place and secure the mesh is estimated to be 10 minutes.

Intervention code [1] 300681 0
Treatment: Devices
Comparator / control treatment
Control: At the time of stoma reversal or resiting, the control group will have routine suture closure of the fascia performed with interrupted 0 polydioxanone sutures.
Control group
Active

Outcomes
Primary outcome [1] 305234 0
Incisional hernia formation at the site of the stoma one year following stoma reversal or re-siting. An incisional hernia will be defined according to the European Hernia Society definition as “any abdominal wall gap with or without a bulge in the area of post-operative scar perceptible or palpable by clinical examination or imaging”. Classification of incisional hernias will be by size, location and reducibility of the contents. This will be assessed by clinical examination in the surgeon's rooms or the outpatients clinic and by abdominal ultrasound at one year following surgery.
Timepoint [1] 305234 0
1 year
Primary outcome [2] 305235 0
Incisional hernia formation at the site of the stoma three years following stoma reversal or re-siting. There is an ongoing risk of incisional hernia formation after surgery with time. An incisional hernia will be defined according to the European Hernia Society definition as “any abdominal wall gap with or without a bulge in the area of post-operative scar perceptible or palpable by clinical examination or imaging”. Classification of incisional hernias will be by size, location and reducibility of the contents. This will be assessed by clinical examination in the surgeon's rooms or the outpatients clinic and by abdominal ultrasound at three years following surgery.
Timepoint [2] 305235 0
3 years
Secondary outcome [1] 344552 0
Surgical site infection. SSI will be defined according to the Centre for Disease Control (CDC) definitions for surgical site infection surveillance. This will be assessed prior to discharge and at a post-operative follow-up visit at approximately 30 days (range 4 - 6 weeks)
Timepoint [1] 344552 0
30 days
Secondary outcome [2] 344553 0
Superficial wound dehisence. Superficial wound dehiscence will be recorded if a previously closed wound opens spontaneously and may not necessarily be associated with the presence of a SSI. This will be assessed prior to discharge and at a post-operative follow-up visit at approximately 30 days (range 4 - 6 weeks).
Timepoint [2] 344553 0
30 days
Secondary outcome [3] 344554 0
Deep wound dehiscence. Deep wound dehiscence will be recorded if there is clinical evidence of dehiscence of the abdominal wall fascia defined as visualisation of separation of the abdominal wall fascia either at clinical examination or at reoperation. The identification of abdominal viscera in the wound base also equates to deep wound dehiscence. This will be assessed prior to discharge and at a post-operative follow-up visit at approximately 30 days (range 4 - 6 weeks)
Timepoint [3] 344554 0
30 days
Secondary outcome [4] 344555 0
Operating time. The start and finish times of the operation are recorded on the operating count sheet by the scrub nurse in charge of the procedure. This information will be collected by the research team.
Timepoint [4] 344555 0
1 days
Secondary outcome [5] 344556 0
Re-operation. Will be defined as an operation to treat post-operative complications associated with the stoma reversal or resiting within 30 days. This outcome will be recorded by the researchers on patient discharge from hospital.
Timepoint [5] 344556 0
30 days
Secondary outcome [6] 344557 0
Re-admission. Any requirement for the patient to be re-admitted to a hospital to manage a complication of the stoma reversal or resiting operation will be recorded by the research team.
Timepoint [6] 344557 0
30 days
Secondary outcome [7] 344558 0
Wound haematoma. A wound haematoma will be defined as a large collection of blood clot at the surgical wound site. Small volumes of blood on surgical dressings will not be included. This will be assessed prior to discharge and at a post-operative follow-up visit at approximately 30 days (range 4 - 6 weeks).
Timepoint [7] 344558 0
30 days

Eligibility
Key inclusion criteria
Patient population: Any adult patients presenting for elective ileostomy or colostomy closure or re-siting.
Inclusion criteria:
1. Age > 18 years
2. Patient with a temporary stoma that has met criteria for stoma reversal or a permanent or temporary stoma that requires resiting.
3. Patient capable of participating in informed consent for the study
4. Patient willing to complete follow-up over the study period (3 years).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1. Pregnancy
2. Pre-existing placement of synthetic non-absorbable mesh in the region of the stoma site.

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)
Central computer randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Phase
Type of endpoint(s)
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)
NSW
Recruitment hospital [1] 10412 0
Westmead Hospital - Westmead
Recruitment hospital [2] 10413 0
Westmead Private Hospital - Westmead
Recruitment hospital [3] 10414 0
Blacktown Hospital - Blacktown
Recruitment hospital [4] 10415 0
Mount Druitt Hospital - Mount Druitt
Recruitment hospital [5] 10416 0
Norwest Private Hospital - Bella Vista
Recruitment postcode(s) [1] 22098 0
2145 - Westmead
Recruitment postcode(s) [2] 22099 0
2148 - Blacktown
Recruitment postcode(s) [3] 22100 0
2770 - Mount Druitt
Recruitment postcode(s) [4] 22101 0
2153 - Bella Vista

Funding & Sponsors
Funding source category [1] 299020 0
Hospital
Name [1] 299020 0
Westmead Hospital
Address [1] 299020 0
Colorectal Department
Hawkesbury Road
Westmead NSW 2145
Country [1] 299020 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Colorectal Department
Hawkesbury Road
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 298243 0
None
Name [1] 298243 0
Address [1] 298243 0
Country [1] 298243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299955 0
Western Sydney Local Health District; Western Sydney Local Health District Human Research Ethics Committee.
Ethics committee address [1] 299955 0
Westmead Hospital
Hawkesbury Road
Westmead Nsw 2145
Ethics committee country [1] 299955 0
Australia
Date submitted for ethics approval [1] 299955 0
19/03/2018
Approval date [1] 299955 0
05/12/2019
Ethics approval number [1] 299955 0
AU RED LNR/18/WMEAD/388

Summary
Brief summary
The rate of incisional hernia formation following closure of a temporary intestinal stoma is approximately 30%. Hernias following abdominal surgery are a significant cause of morbidity and may adversely affect a patient's quality of life and may require emergent repair. Currently closure of the abdominal fascia is accomplished with sutures however, newer surgical materials are now available to reinforce fascial closure which have shown promise in their abilities to reduce IH formation and tolerate bacterial contamination that is present in these contaminated wounds. We propose a randomised clinical trial in patients undergoing reversal or resiting of an intestinal stoma to have placement of a new synthetic tissue reinforcement material or standard repair to determine if this material can reduce incisional hernia formation with low morbidity, specifically surgical site infection which has prohibited the use of existing materials.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82074 0
Dr Graham Ctercteko
Address 82074 0
Head of Department, Colorectal Surgery
Westmead Hospital
Hawkesbury Road
WESTMEAD NSW 2145
Country 82074 0
Australia
Phone 82074 0
+612 8890 5555
Fax 82074 0
Email 82074 0
gramatter@connexus.net.au
Contact person for public queries
Name 82075 0
Dr Graham Ctercteko
Address 82075 0
Head of Department, Colorectal Surgery
Westmead Hospital
Hawkesbury Road
WESTMEAD NSW 2145
Country 82075 0
Australia
Phone 82075 0
+612 8890 5555
Fax 82075 0
Email 82075 0
gramatter@connexus.net.au
Contact person for scientific queries
Name 82076 0
Dr Graham Ctercteko
Address 82076 0
Head of Department, Colorectal Surgery
Westmead Hospital
Hawkesbury Road
WESTMEAD NSW 2145
Country 82076 0
Australia
Phone 82076 0
+612 8890 5555
Fax 82076 0
Email 82076 0
gramatter@connexus.net.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
DATA SECURITY
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 1681 0
Study protocol
Citation [1] 1681 0
Link [1] 1681 0
Email [1] 1681 0
Other [1] 1681 0
Summary results
No Results