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

Registry ID
NCT07766044
Source registry
NCT
Status
RECRUITING
Phase
NA
Study type
INTERVENTIONAL
Sponsor
Suturion AB
Enrollment
218
Start date
2026-07-18
Completion date
2026-12-30
Last update
2026-08-14

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.

Detailed description

This is a single center retrospective study, comparing short and long term abdominal wall related complications among a cohort of 38 patients that underwent abdominal wall closure with a device for standardized laparotomy closure, and a cohort of 180 patients that underwent closure with manual technique during 2020 to 2023. Included patients were selected for open surgery for colorectal disease according to institutions standard practice. Patients will be identified from a previous study on the device for standardized laparotomy closure and the controls will be identified through the operation administrative system. Data on short term complications will be retrieved from the patients chart and incisional hernia will be identified by reviewing the CTscans performed as a part of the standard clinical pathway. Reviewing will be performed according to the EHS classification for incisional hernia by two radiologists blinded for the closure technique. External statistic analysis will be perfromed. Data will be disseminated as a scientific publication.

Interventions

Inclusion criteria

Inclusion Criteria: * \>18 years of age * Patients selected for elective surgical procedure through a midline incision due to colorectal disease

Exclusion criteria

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.

Primary outcomes

[{"measure":"Incisional hernia at 1-year","timeFrame":"1-year"}]

Locations

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