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

NCT05528692 | Withdrawn DMC

• 1 other identifier: HerlevH2
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Incisional Hernia; Emergency Midline Laparotomy

Outcome Measures

Primary Outcomes (1)

• Early (30-days) MRI-diagnosed, incisional hernia development in high-risk patients after emergency midline laparotomy.

  2 years

Secondary Outcomes (4)

• 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

Interventions

Magnetic resonance imaging (MRI) DIAGNOSTIC_TEST

MRI is a non-invasive imaging modality capable of producing precise soft-tissue images in all body areas. In contrast to CT scanning, MRI does not rely on ionizing radiation. There are no known risks associated with MRI as long as patients with contraindications such as pacemakers are identified and excluded. The MRI scans in this study will be performed without use of contrast media.

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 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.

You may qualify if:

• 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

You may not qualify if:

• 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

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

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

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

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 6, 2022
• Study Start: November 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2024-11

Data Sharing

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

Locations

DK (1)