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Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12626001156370
Ethics application status
Approved
Date submitted
24/08/2026
Date registered
17/09/2026
Date last updated
17/09/2026
Date data sharing statement initially provided
17/09/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
Stitch Up; The Pilot.
A pilot study comparing large bite and small bite closure in acute laparotomy to assess rate of recruitment prior to full randomised control trial
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Scientific title
Stitch Up; The Pilot.
A pilot study comparing large bite and small bite closure in acute laparotomy to assess rate of recruitment prior to full randomised control trial
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Additional trial identifiers [1]
317601
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Related trial records
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Health condition
Health condition(s) studied:
Incisional Herniae following acute laparotomy
342372
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Condition category
Condition code
Surgery
338505
338505
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0
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Surgical techniques
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Emergency medicine
339566
339566
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0
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Other emergency care
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
The intervention is small bite closure, defined as placement of stitches 5mm from the edge of abdominal wall fascia (the tough lining of the abdominal wall) and 5mm apart. It will be delivered by appropriately trained consultant and training surgeons at the end of emergency midline laparotomy in the operating theatre.
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Intervention code [1]
334426
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Treatment: Surgery
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Description of the comparator or control
The comparator or control is large bite closure, defined as placement of stitches 10mm from the edge of abdominal wall fascia (the tough lining of the abdominal wall) and 10mm apart. It will be delivered by appropriately trained consultant and training surgeons at the end of emergency midline laparotomy in the operating theatre.
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Control group
Active
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Outcomes
Primary outcome [1]
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Rate of recruitment into trial. This is a composite outcome of people meeting eligibility criteria and the number of people recruited into trial.
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Assessment method [1]
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Number of people that meet criteria, that are enrolled and recruited to the trial. This will be assessed via enrolment logs and audit of study practices.
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Timepoint [1]
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This will be assessed after the recruitment target has been met at the completion of the study.
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Secondary outcome [1]
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Rate of follow up at 30 days
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Assessment method [1]
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Number of people contactable via tele phone at 30 days post intervention
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Timepoint [1]
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30 days following intervention.
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Secondary outcome [2]
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Mortality within 30 days
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Assessment method [2]
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This will be assessed via medical record
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Timepoint [2]
467289
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30 days following intervention
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Secondary outcome [3]
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Functional Independence at 30 days
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Assessment method [3]
467290
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This will be assessed via telephone call at 30 days
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Timepoint [3]
467290
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30 days following intervention
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Eligibility
Key inclusion criteria
Patients that are undergoing an acute laparotomy at Christchurch Public Hospital.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Healthy volunteers
No
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Key exclusion criteria
Patients that have had abdominal surgery within the last 3 months or abdominal hernia repair
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed, opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated random sequence
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
21/09/2026
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
6/01/2027
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Actual
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Sample size
Target
62
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
28210
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New Zealand
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State/province [1]
28210
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Christchurch Public Hospital
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Address [1]
322156
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Country [1]
322156
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New Zealand
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Primary sponsor type
University
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Name
University of Otago
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Address
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
324840
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Country [1]
324840
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
320504
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Northern A Health and Disability Ethics Committee
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Ethics committee address [1]
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https://ethics.health.govt.nz/about/northern-a-health-and-disability-ethics-committee/
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Ethics committee country [1]
320504
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New Zealand
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Date submitted for ethics approval [1]
320504
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03/04/2025
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Approval date [1]
320504
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09/05/2026
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Ethics approval number [1]
320504
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21130
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Summary
Brief summary
Incisional herniae are a major problem following surgery, and there is evidence in the elective setting to show closing the fascia (the strong layer of the abdominal wall) with small bites (5mm steps between sutures) is better than large bites (10mm steps between sutures) at preventing herniae. This has not been explored in the acute setting though. Our study is a pilot study for a randomised study comparing these two methods of care in the acute setting. We will be checking that patients can be recruited into the study, not disadvantaged in the short term, and are suitable for long term follow up.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Jonathan Morreau
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Address
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University of Otago, Christchurch Campus. 2 Riccarton Avenue, Christchurch Central City, Christchurch 8011
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Country
150686
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New Zealand
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Phone
150686
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+64211397420
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Fax
150686
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Email
150686
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[email protected]
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Contact person for public queries
Name
150687
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Jonathan Morreau
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Address
150687
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University of Otago, Christchurch Campus 2 Riccarton Avenue, Christchurch Central City, Christchurch 8011
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Country
150687
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New Zealand
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Phone
150687
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+64211397420
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Fax
150687
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Email
150687
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[email protected]
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Contact person for scientific queries
Name
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Jonathan Morreau
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Address
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University of Otago, Christchurch Campus. 2 Riccarton Avenue, Christchurch Central City, Christchurch 8011
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Country
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New Zealand
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Phone
150688
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+64211397420
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Fax
150688
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Email
150688
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
No requirements
What individual participant data might be shared?
•
De-identified individual participant data:
•
All outcomes data
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Published results
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Primary outcome(s)
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Safety data
What types of analyses could be done with individual participant data?
•
Any type of analysis (i.e. no restrictions on data re-use)
•
Systematic reviews and meta-analyses
•
Studies exploring new research questions
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Health economic analyses
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Studies testing whether findings can be repeated or confirmed
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Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
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.
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