Risk Factors of Incisional Hernias After Emergency Midline Laparotomy

Incisional Hernia Clinical Trial

— INCISE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05509452
• Other study ID #: HerlevH1
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: March 2027

Study information

• Verified date: October 2023
• Source: Herlev Hospital
• Contact: Madeline Kvist, MB
• Phone: 0045 38681410
• Email: madeline.kvist[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: March 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Hernia
• Incisional Hernia

Locations

Country	Name	City	State
Denmark	Department of Gastrointestinal- and Hepatic diseases, Surgical Section,	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors of incisional hernia after emergency midline laparotomy	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	2 years
Secondary	Rate of incisional hernias one and two years after surgery		2 years
Secondary	30-day, 90-day, 1-year and 2-year mortality		2 years
Secondary	Rates of asymptomatic versus symptomatic incisional hernias		2 years
Secondary	Rate of surgery for incisional hernias 2-years post index surgery		2 years