Status:
COMPLETED
Preoperative High-dose Dexamethasone and Emergency Laparotomy
Lead Sponsor:
Mirjana Cihoric
Conditions:
Intestinal Obstruction and Ileus
Perforated Viscus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of this trial is to evaluate the effect of high-dose glucocorticoid on inflammatory response and recovery after emergency laparotomy in participants with intestinal obstruction and perforated ...
Detailed Description
Surgical trauma and accompanying inflammation results in increased capillary permeability leading to tissue edema. Since the vascular endothelium contributes to homeostasis, endothelial damage may inc...
Eligibility Criteria
Inclusion
- Adults (18 years or over) undergoing emergency laparotomy (laparotomy or laparoscopy) for following abdominal pathology:
- Primary perforated viscus (perforated ulcer, small intestine or colon)
- Primary intestinal obstruction ( small intestine or colon)
- Provided verbal and written informed consent
- Must speak and understand the Danish language
Exclusion
- 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.
- Emergency re-operations after elective surgery owing to paralytic/obstructive ileus, perforated viscus, anastomotic leakage
- 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.
- Intestinal Ischemia
- intraabdominal bleeding
- Traumas, gynecological, urogenital and other vascular pathology, pregnant participants.
- Dementia and/or cognitive dysfunction (diagnosed).
- Participants not oriented in time, place and person
- Insuline treatment for diabetes mellitus type I and II
- Current treatment with systemic glucocorticoids or immune suppressive treatment ( apart from inhalation steroids)
- Allergies to trial medicine
- \-
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04791566
Start Date
March 1 2021
End Date
December 9 2022
Last Update
December 14 2022
Active Locations (1)
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1
Mirjana Cihoric
Hvidovre, Denmark, 2650