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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Suturion AB • ClinicalTrials.gov ID: NCT07766044

Registry updated: 2026-09-02
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Description

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.

Interventions

  • Device assisted laparotomy closure (Device)
    SutureTOOL is a single patient device for standardized laparotomy closure. The devices use a 2/0 polydioxanone suture and secures a small-bites closure.
  • Manual laparotomy closure (Behavioral)
    Standard practice of laparotomy closure using standard needle driver and curved needle

Eligibility 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.

Conditions

Incisional Hernia After Midline Laparotomy Colorectal Cancer

Locations

  • Helsingborg hospital — Helsingborg, Skåne County, Sweden
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record