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

Incisional Hernia Clinical Trial

— MAGELA  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05528692
• Other study ID #: HerlevH2
• Status: Suspended
• Start date: February 2024
• Est. completion date: June 2027

Study information

• Verified date: October 2023
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: June 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Hernia
• Incisional Hernia

Intervention

Diagnostic Test:
• Magnetic resonance imaging (MRI)
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.

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	Early (30-days) MRI-diagnosed, incisional hernia development in high-risk patients after emergency midline laparotomy.		2 years
Secondary	MRI-diagnosed incisional hernia rates 3 months, 6 months and 2 years after laparotomy.		2 years
Secondary	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
Secondary	Rate of MRI-verified subclinical vs. clinical detectable incisional hernias.		2 years
Secondary	30-day, 90-day, and 1-year mortality.		1 year