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RECRUITING
NCT07766044
NA

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

Sponsor: Suturion AB

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

218

Start Date

2026-07-18

Completion Date

2026-12-30

Last Updated

2026-09-02

Healthy Volunteers

No

Interventions

DEVICE

Device 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.

BEHAVIORAL

Manual laparotomy closure

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

Locations (1)

Helsingborg hospital

Helsingborg, Skåne County, Sweden