Risk Factors of Incisional Hernias After Emergency Midline Laparotomy

Not yet recruiting

• Conditions: Emergency Midline Laparotomy; Incisional Hernia

• Registration Number: NCT05509452
• Lead Sponsor: Herlev Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-22
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-27
• Study Start: 2024-02
• Primary Completion: 2027-01
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk factors of incisional hernia after emergency midline laparotomy	2 years	Multivariate analysis on selected variables evaluated for long-term complications, including sex, age, high BMI, active smoking, hernia in the midline, length of incision, rectus muscle diastasis, sarcopenia, peritonitis and multiple laparotomies

Secondary Outcome Measures

Name	Time	Method
30-day, 90-day, 1-year and 2-year mortality	2 years
Rates of asymptomatic versus symptomatic incisional hernias	2 years
Rate of incisional hernias one and two years after surgery	2 years
Rate of surgery for incisional hernias 2-years post index surgery	2 years

Trial Locations

Locations (1)

Department of Gastrointestinal- and Hepatic diseases, Surgical Section,; 🇩🇰 Herlev, Denmark