Hernia Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \>18 years of age

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

Locations
Other Locations
Sweden
Helsingborg hospital
RECRUITING
Helsingborg
Time Frame
Start Date: 2026-07-18
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 218
Treatments
Active_comparator: Device assisted laparotomy closure
38 patients undergoing elective treatment for colorectal diseases and abdominal wall closure with a device for standardized laparotomy closure
Other: Manual laparotomy closure
180 patients undergoing elective treatment for colorectal diseases and abdominal wall closure by manual laparotomy closure
Related Therapeutic Areas
Sponsors
Leads: Suturion AB
Collaborators: Lund University, Region Skåne Sweden

This content was sourced from clinicaltrials.gov