NCT05509452

Risk Factors of Incisional Hernias After Emergency Midline Laparotomy

Risk Factors of Incisional Hernias After Emergency Midline Laparotomy: a Danish Prospective Single-center, Non-randomized, Non-interventional, Descriptive Follow-up Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Herlev Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to identify risk factors for the development of incisional hernias in emergency midline laparotomies.

Detailed description

All patients operated with an emergency midline laparotomy and attending 1-year follow-up in our clinic is potential participants and will be screened for participation. Potential participants will be briefly informed about the project by the hospital staff. If the patients are interested, they will be thoroughly informed about the study and asked to participate by one of the trial investigators before discharge. Data will be obtained from the participants hospital files and by patient survey/interview. All data will be entered into a database using RedCap by trial investigators or their delegates. Enrolled patients will be followed for two years. The trial involves two clinical examinations and evaluations (one and two years) after surgery. Clinical examination involves interview with a standardized questionnaire and abdominal wall examination including inspection, palpation and ultrasound examination.

Conditions

• Incisional Hernia
• Emergency Midline Laparotomy

Timeline

• Start date: 2024-02-01
• Primary completion: 2027-01-01
• Completion: 2027-03-01
• First posted: 2022-08-22
• Last updated: 2023-10-27

Locations

1 site across 1 country: Denmark