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Perioperative Metabolic and Hormonal Aspects in Major Emergency Surgery

NCT03482830 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 98

Last updated 2020-01-22

No results posted yet for this study

Summary

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.

Conditions

  • Surgery--Complications
  • Acute Illness
  • Gastrointestinal Disease
  • Stress

Interventions

PROCEDURE

Major emergency gastrointestinal surgery

* Open, laparoscopic, or laparoscopically-assisted procedures * Procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction

Sponsors & Collaborators

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Jakob Burcharth, MD, PhD · Zealand University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2018-11-01
Completion
2019-11-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03482830 on ClinicalTrials.gov