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CLOSE Trial - The Effect of Closure Technique on Incisional Hernia from Emergency Laparotomy: Small vs Large Bites Evaluation

CLOSE Trial - The Effect of Closure Technique on Incisional Hernia from Emergency Laparotomy: Small vs Large Bites Evaluation

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626001143314
Enrollment
492
Registered
2026-09-15
Start date
2026-10-01
Completion date
2029-06-01
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Midline laparotomy closure techniques strongly influence postoperative wound outcomes, particularly incisional hernia, a frequent and clinically significant complication associated with pain, functional impairment, and reoperation. This is especially relevant in emergency laparotomy, where patients are physiologically compromised and at higher risk of contamination, infection, and impaired healing. We conduct this trial to compare small-bites versus large-bites fascial closure in emergency laparotomy to determine whether the benefits observed in elective and mixed surgical populations translate to this higher-risk setting.

Interventions

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. A

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.

Sponsors

Northern Adelaide Local Health Network
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Aged 18 years and over - Emergency laparotomy planned for same admission

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 15, 2026