Risk Factors of Incisional Hernias After Emergency Midline Laparotomy

NCT05509452 | Not Yet Recruiting DMC

• 1 other identifier: HerlevH1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Incisional Hernia; Emergency Midline Laparotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Rate of incisional hernias one and two years after surgery

  2 years

• 30-day, 90-day, 1-year and 2-year mortality

  2 years

• Rates of asymptomatic versus symptomatic incisional hernias

  2 years

• Rate of surgery for incisional hernias 2-years post index surgery

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Department of Gastrointestinal- and Hepatic diseases, Surgical Section,

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Central Study Contacts

Madeline Kvist, MB

CONTACT

0045 38681410; madeline.kvist@regionh.dk

Thomas K Jensen, MD

CONTACT

0045 38681633; thomas.korgaard.jensen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 22, 2022
• Study Start: February 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

DK (1)