Last reviewed · How we verify
NCT03482830: PHASE
Perioperative Metabolic and Hormonal Aspects in Major Emergency Surgery
trial testing Major emergency gastrointestinal surgery in Surgery--Complications in 98 participants. Completed in 1 November 2019.
1 November 2018
Quick facts
| Lead sponsor | Zealand University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 98 |
| Start date | 5 March 2018 |
| Primary completion | 1 November 2018 |
| Estimated completion | 1 November 2019 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Major emergency gastrointestinal surgery
Conditions studied
- Surgery--Complications — all drugs for Surgery--Complications →
- Acute Illness — all drugs for Acute Illness →
- Gastrointestinal Disease — all drugs for Gastrointestinal Disease →
- Stress — all drugs for Stress →
Sponsor
Zealand University Hospital
Who can join
18 and older, any sex, with Surgery--Complications or Acute Illness. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Emergency laparotomies, which most often is performed due to high risk disease (bowel obstruction, ischemia, perforation, etc.), make up 11 % of surgical procedures in emergency surgical departments, however, give rise to 80 % of all postoperative complications. The 30-day mortality rates in relation to these emergent procedures have been reported between 14-30 %, with even higher numbers for frail and older patients. The specific reasons for these outcomes are not yet known, however, a combination of preexisting comorbidities, acute illness, sepsis, and the surgical stress response that arise during- and after the surgical procedure due to the activation of the immunological and humoral system, is most likely to blame. The complex endocrinological response and consequences of this response to emergency surgery are sparsely reported in the literature. The aim of this PHASE project is to evaluate and describe the temporal endocrine, endothelial and immunological changes after major emergency abdominal surgery, and to associate these changes with clinical postoperative outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03482830
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Zealand University Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03482830 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zealand University Hospital
- Last refreshed: 22 January 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03482830.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing