Risk Factors of Incisional Hernias After Emergency Midline Laparotomy (INCISE)

Herlev Hospital

Status: Not yet enrolling

Conditions: Emergency Midline Laparotomy; Incisional Hernia

Study type: Observational

Funder types: Other

Identifiers

NCT05509452

HerlevH1

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age of 18 years or above and
• Unscheduled midline laparotomy in an emergency or subacute setting, involving perforated bowel, bowel obstruction, bowel ischemia (due to mesenteric vascular disease or incarceration), inflammatory diseases (e.g. diverticulitis, appendicitis, ulcerative colitis, cholecystitis and Crohn's disease), abscesses, non-traumatic intraabdominal bleeding and any emergency re-operation to elective surgery

Exclusion criteria

• Age below 18 years
• Patients with mental or physical disorders making follow-up impossible
• Patients were no fascial closure is performed