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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001143314p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
24/08/2026
Date registered
Help: Date registered
15/09/2026
Date last updated
Help: Date last updated
15/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
15/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
CLOSE Trial - The Effect of Closure Technique on Incisional Hernia from Emergency Laparotomy: Small vs Large Bites Evaluation
Scientific title
CLOSE Trial - The Effect of Closure Technique on Incisional Hernia from Emergency Laparotomy: Small vs Large Bites Evaluation
Additional trial identifiers [1] 318260 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
midline emergent laparotomy 343326 0
incision hernia 343327 0
Condition category
Condition code
Emergency medicine 339431 339431 0 0
Other emergency care
Surgery 339537 339537 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is the method used to close the abdominal fascia (the strong layer of tissue in the abdominal wall) at the end of an emergency laparotomy. Participants are randomly assigned to one of two standard techniques:
Intervention:
- Small-bites closure: Using 2-0 PDS sutures placed 5 mm from the fascial edge and 5 mm apart. In this study, the small-bites closure is considered the intervention.

The intervention is delivered by the operating surgeon performing the emergency laparotomy. All participating surgeons are qualified medical practitioners (MBBS, FRACS) working in emergency surgical services at the participating hospitals. The intervention is delivered intraoperatively (during surgery) in the operating theatre. It is an individual, one-time procedure performed on each participant during their emergency laparotomy.
Adherence to the assigned closure technique is monitored through:
- Randomisation via REDCap: Study staff access the REDCap database approximately 15 minutes before fascial closure to determine the allocated technique, which is then communicated to the operating surgeon.
- Data recording: The operating team records the length of the wound, number of sutures used, and time taken to close the fascia, allowing verification that the correct technique was applied.
- Stratified randomisation: Randomisation is stratified by study site to minimise variation related to site-specific surgical practice or surgeon skill.

Small bites and large bites instruction
Small Bites: 2-0 PDS (needle size) with 5mm between bites and from fascial edge.
Not to include muscle or fat into the closure. This may mean having to clear the suprafascial fat from fascia.

Each suture should be separately knotted with an Aberdeen’s knot – NOT TOGETHER.
Include length of wound and number of sutures used. Include time taken to close fascia.
Intervention code [1] 335148 0
Treatment: Surgery
Description of the comparator or control
The comparator in this trial is the large-bites fascial closure technique, which represents the traditional and widely used standard method for closing midline laparotomy wounds.

Large Bites: 1-PDS (needle size) with 10mm between bites and from fascial edge.
Suturing begins at the cranial and caudal ends, meeting in the middle of the wound with a 1cm overlap.

Participants allocated to the comparator group will have their abdominal fascia closed using 1 PDS sutures. The stitches will be placed approximately 10 mm from the edge of the fascia and 10 mm apart. Closure will begin at the upper (cranial) and lower (caudal) ends of the incision, with the sutures meeting in the middle and overlapping by approximately 1 cm. Each suture will be tied separately using an Aberdeen knot. Muscle and fat are not included in the closure.
This technique has been the conventional approach for many years and serves as the control against which the small-bites method is being compared to determine whether it offers superior outcomes in terms of reducing incisional hernia and other postoperative wound complications in the emergency laparotomy setting.
Control group
Active

Outcomes
Primary outcome [1] 346645 0
Incidence of incisional hernia within 12 months after emergency laparotomy
Timepoint [1] 346645 0
Baseline immediately post-operation, 6 weeks post-operation, and 12 months post-operation
Secondary outcome [1] 466867 0
Rates of postoperative complications surgical site infection.
Timepoint [1] 466867 0
at 6 weeks and 12 months post-operation
Secondary outcome [2] 466879 0
closure time between two techniques
Timepoint [2] 466879 0
day of operation after completion of surgery
Secondary outcome [3] 466886 0
patient’s quality of life
Timepoint [3] 466886 0
6 weeks and 12 months post-operation
Secondary outcome [4] 467162 0
Rate of post-operative wound dehiscence
Timepoint [4] 467162 0
Baseline immediately post-operation, 6 weeks post-operation, and 12 months post-operation
Secondary outcome [5] 467163 0
Rate of post-operative burst abdomen
Timepoint [5] 467163 0
Baseline immediately post-operation, 6 weeks post-operation, and 12 months post-operation
Secondary outcome [6] 467164 0
length of hospital stay
Timepoint [6] 467164 0
Date of admission, date of discharge
Secondary outcome [7] 467165 0
Rate of readmission
Timepoint [7] 467165 0
6 weeks post-operation, 12 months post-operation
Secondary outcome [8] 467166 0
Rate of returning to theatre
Timepoint [8] 467166 0
6 weeks post-operation, 12 months post-operation

Eligibility
Key inclusion criteria
- Aged 18 years and over
- Emergency laparotomy planned for same admission
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
- Abdominal operations through midline incision within the previous 3 months.
- Laparostomy closures
- Previous incisional hernia repair > 5cm
- Pregnancy during or in the 1 year follow up period.

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)
- Centralised randomisation via REDCap: Randomisation is performed using the secure, web-based REDCap platform hosted on the SA Health server. The randomisation sequence is generated and stored within REDCap, inaccessible to recruiting staff and operating surgeons until the point of allocation.
-Timing of allocation disclosure: Randomisation occurs approximately 15 minutes before fascial closure, after the patient has consented and surgery is underway. Only at this point does study staff access REDCap to complete the randomisation, and the operating surgeon is then informed of the assigned closure technique. This prevents foreknowledge of the allocation during patient recruitment or the earlier stages of the operation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
-Stratified randomisation: Randomisation is stratified by study site (Lyell McEwin Hospital, Royal Adelaide Hospital, Mount Gambier Hospital, and Flinders Medical Centre) in a 1:1 ratio. This ensures balance across sites while maintaining concealment of the sequence within each stratum.
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2026
Actual
Date of last participant enrolment
Anticipated
1/06/2029
Actual
Date of last data collection
Anticipated
1/06/2030
Actual
Sample size
Target
492
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 322810 0
Government body
Name [1] 322810 0
Northern Adelaide Local Health Network
Country [1] 322810 0
Australia
Primary sponsor type
Government body
Name
Northern Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 325740 0
None
Name [1] 325740 0
Address [1] 325740 0
Country [1] 325740 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 321250 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 321250 0
Ethics committee country [1] 321250 0
Australia
Date submitted for ethics approval [1] 321250 0
24/08/2026
Approval date [1] 321250 0
Ethics approval number [1] 321250 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 153146 0
Dr Priya Nandoskar
Address 153146 0
Division of Surgical Specialties and Anaesthesia, Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, SA 5112
Country 153146 0
Australia
Phone 153146 0
+61 8 81829000
Fax 153146 0
Email 153146 0
[email protected]
Contact person for public queries
Name 153147 0
Priya Nandoskar
Address 153147 0
Division of Surgical Specialties and Anaesthesia, Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, SA 5112
Country 153147 0
Australia
Phone 153147 0
+61 8 81829000
Fax 153147 0
Email 153147 0
[email protected]
Contact person for scientific queries
Name 153148 0
Priya Nandoskar
Address 153148 0
Division of Surgical Specialties and Anaesthesia, Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, SA 5112
Country 153148 0
Australia
Phone 153148 0
+61 8 81829000
Fax 153148 0
Email 153148 0
[email protected]

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:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
5 years post publication

Where can requests to access individual participant data be made, or data be obtained directly?
• Appropriate request sent directly to trial CPI via email [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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
ProtocolNo CLOSE Trial Protocol version 1.0 24082026.docx

Documents added automatically
No additional documents have been identified.