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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
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05509452
Acronym
INCISE
Enrollment
0
Registered
2022-08-22
Start date
2026-06-01
Completion date
2028-03-01
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergency Midline Laparotomy, Incisional Hernia

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.

Interventions

None listed

Sponsors

Herlev Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Risk factors of incisional hernia after emergency midline laparotomy2 yearsMultivariate 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

MeasureTime frame
Rate of incisional hernias one and two years after surgery2 years
30-day, 90-day, 1-year and 2-year mortality2 years
Rates of asymptomatic versus symptomatic incisional hernias2 years
Rate of surgery for incisional hernias 2-years post index surgery2 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026