Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT05528692
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05528692
Study Brief:
Protocol Section:
NCT05528692