High-dose steroid and it effect on body's response against infection and recovery after emergency abdominal surgery, a lottery-based double blinded controlled study

Phase 1

• Conditions: Patients undergoing emergency laparotomy due to either Intestinal obstruction or perforated abdominal viscus.; MedDRA version: 21.1Level: PTClassification code 10053361Term: Explorative laparotomySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.1Level: PTClassification code 10051379Term: Systemic inflammatory response syndromeSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 22.0Level: PTClassification code 10021328Term: IleusSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.0Level: LLTClassification code 10034406Term: Perforation bowelSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.0Level: LLTClassification code 10034430Term: Perforation stomachSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-002586-34-DK
• Lead Sponsor: Department of Anesthesiology, Copenhagen University Hospital Hvidovre, Capital Region of Denmark

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-13
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1.Adults (18 years or over) undergoing emergency laparotomy (laparotomy or laparoscopy) for following abdominal pathology:
a.Primary perforated viscus (perforated ulcer, small intestine or colon)
b.Primary intestinal obstruction ( small intestine or colon)
2.Provided verbal and written informed consent
3.Must speak and understand the Danish language

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified