RecruitingNot ApplicableNCT07766044

A One-year Follow-up of Incisional Hernia Formation Between Device Assisted and Manual Laparotomy Closure

A One-year Follow-up Comparison of Incisional Hernia Formation Between Device Assisted and Manual Closure in Patients Undergoing Elective Laparotomy for Colorectal Diseases


Sponsor

Suturion AB

Enrollment

218 participants

Start Date

Jul 18, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The study compares one-year incisional hernia formation between two cohorts of patients that underwent open surgery for colorectal diseases. The patients had the abdominal wall closure performed with either a device for standardized closure or manual closure. The devices aims to secure the closure technique that is advocated by guidelines and could potentially reduce abdominal wall complications. Upholding closure quality can be cumbersome and time consuming and hence inferior closure can sometimes be associated with manual closure. Follow-up will include short term complications like wound infection and burst abdomen and one-year follow-up include a review of patients chart and CTscans performed as part of standard clinical practice.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Device assisted laparotomy closure and a behavioral approach called Manual laparotomy closure for people with colorectal, cancer and incisional hernia after midline laparotomy. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDevice assisted laparotomy closure

SutureTOOL is a single patient device for standardized laparotomy closure. The devices use a 2/0 polydioxanone suture and secures a small-bites closure.

BEHAVIORALManual laparotomy closure

Standard practice of laparotomy closure using standard needle driver and curved needle


Locations(1)

Helsingborg hospital

Helsingborg, Skåne County, Sweden

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NCT07766044


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