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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuturion AB

About this trial

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 criteria

Qualifiers

>18 years of age

Patients selected for elective surgical procedure through a midline incision due to colorectal disease

Disqualifiers

Previous surgery including the midline

Previous hernia including the midline

Collagen disease

Disseminated disease at the time of surgery

Trial design

Treatments tested in this trial

  • Device assisted laparotomy closure
  • Manual laparotomy closure

Treatment groups

218 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Suturion AB

Lead sponsor

Lund University

Sponsor institution

Lund University

Collaborator

Region Skåne Sweden

Collaborator