The Time-Dependent Development of Incisional Hernias in Emergency Laparotomy Incisions of High-Risk Patients (MAGELA)

The Time-Dependent Development of Incisional Hernias in Emergency Laparotomy Incisions of High-Risk Patients: a Danish Prospective Single-center, Non-randomized, Non-interventional, Observational Study

The aim of this study is to describe the development of symptomatic and asymptomatic incisional hernias after emergency midline laparotomy over time in high-risk patients evaluated by consecutive MRI-scans.

Study Overview

• Status: Withdrawn
• Conditions: Incisional Hernia; Emergency Midline Laparotomy
• Intervention / Treatment: Diagnostic test: Magnetic resonance imaging (MRI)

Detailed Description

All patients operated with an emergency midline laparotomy in our clinic are 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 four consecutive MRI-scans one month, three months, six months and two years after surgery. Change in quality of life, physical functioning and pain-score are also obtained by patient survey/interview at each visit. A concluding physical examination and abdominal wall ultrasound examination will be performed two years after the surgery.

• Study Type: Observational

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Department of Gastrointestinal- and Hepatic diseases, Surgical Section,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Any patient operated with an emergency midline laparotomy in our clinic will be evaluated for enrollment. Patients will be eligible if they comply with the listed inclusion and exclusion criteria.

We aim to enroll 100 patients to ensure that 50 patients fulfill the study protocol. This is based on a risk of incisional hernia development of at least 30% over two years among the included high-risk participants, a two-year mortality of the participants as a group of 30% and a 20% loss to follow-up amongst the survivors.

Description

Inclusion Criteria:

• 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 or any emergency re-operation to elective surgery
• Age of 18 years or above
• BMI above 27
• At least one risk factor for incisional hernia i.e. earlier midline laparotomy, BMI > 30, abdominal aortic aneurysm or prior surgery for abdominal aortic aneurysm, active smoking, liver cirrhosis, re-laparotomy, age > 75, history of primary ventral hernia (treated or untreated before index surgery), large laparotomy involving more than 2/3 of the abdominal wall as measured from the xiphoid process to the pubic bone

Exclusion Criteria:

• Malign, incurable disease
• Other reasons for short life expectancy <2 year as evaluated by the investigator
• Midline-incisions <15 cm
• Mesh augmentation of abdominal wall closure at index surgery or earlier mesh augmentation of the abdominal wall
• Severe claustrophobia or any other mental habitus, making it impossible to perform MRI-scan without sedation
• Metallic magnetic implants that serves as a contraindication for MRI-scan (including pacemakers, large tattoos, insulin pumps, etc.)
• Metallic prosthetic non-magnetic implants that are suspected to create severe artefacts on the MRI-scan of the abdominal wall

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Early (30-days) MRI-diagnosed, incisional hernia development in high-risk patients after emergency midline laparotomy.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
MRI-diagnosed incisional hernia rates 3 months, 6 months and 2 years after laparotomy.	2 years
Change in quality of life, physical functioning, clinical investigation and pain-score at 1 month, 3 months, 6 months and 2 years after laparotomy.	2 years
Rate of MRI-verified subclinical vs. clinical detectable incisional hernias.	2 years
30-day, 90-day, and 1-year mortality.	1 year

Collaborators and Investigators

• Sponsor: Herlev Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Hernia; Pathological Conditions, Signs and Symptoms; Incisional Hernia; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Magnetic Resonance Imaging
• Other Study ID Numbers: HerlevH2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All results, both positive, negative and inconclusive, will be attempted to be published in international English journals with external reviewers. Alternatively, the results will be published in another way.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No