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 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT04791566
Eligibility Criteria:
Inclusion Criteria:
1. Adults (18 years or over) undergoing emergency laparotomy (laparotomy or laparoscopy) for following abdominal pathology:
1. Primary perforated viscus (perforated ulcer, small intestine or colon)
2. Primary intestinal obstruction ( small intestine or colon)
2. Provided verbal and written informed consent
3. Must speak and understand the Danish language
Exclusion Criteria:
1. Appendectomies, cholecystectomies, negative diagnostic laparoscopies/laparotomies, herniotomies without bowel resections, sub-acute internal hernias after gastric bypass surgery, sub-acute surgery for inflammatory bowel diseases.
2. Emergency re-operations after elective surgery owing to paralytic/obstructive ileus, perforated viscus, anastomotic leakage
3. Reoperation owing to fascial separation with no other abdominal pathology identified and sub-acute colorectal cancer-surgery will be excluded from the cohort. Sub-acute surgery is defined as surgery planned within 48 hours.
4. Intestinal Ischemia
5. intraabdominal bleeding
6. Traumas, gynecological, urogenital and other vascular pathology, pregnant participants.
7. Dementia and/or cognitive dysfunction (diagnosed).
8. Participants not oriented in time, place and person
9. Insuline treatment for diabetes mellitus type I and II
10. Current treatment with systemic glucocorticoids or immune suppressive treatment ( apart from inhalation steroids)
11. Allergies to trial medicine
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04791566
Study Brief:
Protocol Section:
NCT04791566