Device-assisted laparotomy closure versus manual closure after colorectal surgery
Official title: A One-year Follow-up Comparison of Incisional Hernia Formation Between Device Assisted and Manual Closure in Patients Undergoing Elective Laparotomy for Colorectal Diseases
Run by Suturion AB · NCT07766044 · Data updated 2026-11-12
This study tests whether using a device for standardized abdominal wall closure reduces incisional hernias and other complications one year after open colorectal surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 218 (estimated) |
| Sponsor | Suturion AB Industry-sponsored |
| Locations | 1 site (Helsingborg, Skåne County) |
| Status | Recruiting |
| Started | July 18, 2026 |
| Main results expected | October 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT07766044 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 undergoing elective midline open colorectal surgery.
✕Probably not a fit
Patients who do not develop incisional hernias or who have factors limiting benefits (e.g., prior midline surgery) may not see benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center retrospective analysis compares two groups: 38 patients whose midline incisions were closed with a device for standardized closure and 180 patients closed manually, from 2020–2023. The main outcome is incisional hernia at one year, assessed by CT scans and radiologists blinded to the closure method, with short-term complications also documented. Data will be drawn from medical charts and imaging obtained as part of routine care, and analyzed externally. Results will be published in a scientific journal.
Why it matters
Potential benefit: If successful, device-assisted closure could reduce long-term abdominal wall complications for patients undergoing open colorectal surgery.
How similar studies have gone: Previous work on standardized closure devices has shown potential in reducing complications, but data in this specific context are limited and additional confirmation is needed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>18 years of age * Patients selected for elective surgical procedure through a midline incision due to colorectal disease Exclusion Criteria: * Previous surgery including the midline * Previous hernia including the midline * Collagen disease * Disseminated disease at the time of surgery * Life expectancy less than 1 year.
Where it's running
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Helsingborg hospital
Helsingborg, Skåne County, Sweden Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.