Clinical trial NCT05509452: Risk Factors of Incisional Hernias After Emergency Midline Laparotomy
Official title: Risk Factors of Incisional Hernias After Emergency Midline Laparotomy: a Danish Prospective Single-center, Non-randomized, Non-interventional, Descriptive Follow-up Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Incisional Hernia
Emergency Midline Laparotomy
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient operated with an emergency midline laparotomy and followed up in our clinic will be evaluated for enrollment. Patients will be eligible if they comply with the inclusion and exclusion criteria listed above.

We aim to include a total of 500 patients for the first follow-up. This is based on a drop out and long-term death of approximately 50%, incisional hernia rate of 20% and 10 risk factors in multivariate analysis requiring 100 patients with incisional hernias. 100 incisional hernias = 500 patients included at first post-operative follow up.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Risk factors of incisional hernia after emergency midline laparotomy
timeFrame: 2 years
Secondary outcomes:
measure: Rate of incisional hernias one and two years after surgery
timeFrame: 2 years
measure: 30-day, 90-day, 1-year and 2-year mortality
timeFrame: 2 years
measure: Rates of asymptomatic versus symptomatic incisional hernias
timeFrame: 2 years
measure: Rate of surgery for incisional hernias 2-years post index surgery
timeFrame: 2 years
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Gastrointestinal- and Hepatic diseases, Surgical Section,
Study officials:
References: