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Completed

NCT Number: NCT03482830

Perioperative Metabolic and Hormonal Aspects in Major Emergency Surgery

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.

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Key information

Conditions

Surgery--Complications Acute Illness Digestive System Diseases Gastrointestinal Disease Gastrointestinal Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery, Zealand University Hospital

Køge, 2300, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Surgery within 72 hours of an acute admission to the Department of Surgery or an acute reoperation.
  • Major gastrointestinal surgery on the gastrointestinal tract (see intervention definition)

Exclusion criteria

  • Not capable of giving informed consent after oral and written information
  • Previously included in the trial
  • Elective laparoscopy
  • Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (NB, if no procedure is performed because of inoperable pathology, then include)
  • Appendectomy +/- drainage or Cholecystectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract
  • Non-elective hernia repair without bowel resection.
  • Minor abdominal wound dehiscence unless this causes bowel complications requiring resection
  • Ruptured ectopic pregnancy, or pelvic abscesses due to pelvic inflammatory disease
  • Laparotomy/laparoscopy for pathology caused by blunt or penetrating trauma, esophageal pathology, pathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract

Treatment and study plan

Major emergency gastrointestinal surgery

Procedure
  • 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

Primary outcomes

  1. Changes of immunological biomarkers

    Time frame: Change from preoperative levels at postoperative day 5

    Assessment of:

    • plasma inflammatory interleukines incl. IL-1-alfa, IL-1beta, IL-6, IL-10
    • plasma TNF-alfa
    • plasma TGF-beta

  2. Number of patients with stress induced hyperglycemia

    Time frame: Postoperative day 5

    Assessment of:

    • Blood glucose, plasma c-peptide, HbA1C
    • plasma Glucagon-like peptide 1 (GLP-1)

  3. Changes of plasma thyroid hormones

    Time frame: Change from preoperative levels at postoperative day 5

    Assessment of:

    • Thyropin-releasing hormone (TRH)
    • Thyroid-stimulating hormone (TSH)
    • Thyroid hormones (fT3, fT4, rT3)

  4. Changes of the central endocrine stress response

    Time frame: Change from preoperative levels at postoperative day 5

    Assessment of plasma corticotropin releasing hormone (CRH)

  5. Changes of sE-selectin

    Time frame: Change from preoperative levels at postoperative day 5

    Assessment of plasma sE-selectine

    • sE-selectin
    • syndecan-1
    • thrombomodulin
    • sVE-cadherin

  6. Changes of the endothelial function

    Time frame: Change from postoperative day 1 at postoperative day 5

    Assessed with the non-invasive EndoPAT and expressed as the reactive hyperemia index

  7. Changes of the periferal endocrine stress response

    Time frame: Change from preoperative levels at postoperative day 5

    Assessment of plasma adrenocorticotropic hormone (ACTH)

  8. Changes of cortisol

    Time frame: Change from preoperative levels at postoperative day 5

    Assessment of plasma cortisol (free and bound)

  9. Changes of neuropeptides

    Time frame: Change from preoperative levels at postoperative day 5

    Assessment of plasma neuropeptides

  10. Changes of syndecan-1

    Time frame: Change from preoperative levels at postoperative day 5

    Assessment of plasma syndecan-1

  11. Changes of thrombomodulin

    Time frame: Change from preoperative levels at postoperative day 5

    Assessment of plasma thrombomodulin

  12. Changes of sVE-cadherin

    Time frame: Change from preoperative levels at postoperative day 5

    Assessment of plasma sVE-cadherin

Secondary outcomes

  1. Number of patients with major adverse cardiovascular events

    Time frame: 365 days after surgery

    Defined as:

    • Cardiovascular death
    • Myocardial injury within postoperative day 4 (definition: peak plasma cardiac troponin-I ≥ 45ng/L (99th percentile URL, 10% CV at 40ng/L))
    • Acute coronary syndrome (unstable angina pectoris, NSTEMI, STEMI)
    • Congestive heart failure
    • Stroke
    • Nonfatal cardiac arrest
    • New clinically important cardiac arrhythmia
    • Coronary revascularization procedure (PCI or CABG)
    • Sudden unexpected death

  2. Number of patients with postoperative non-cardiovascular complications

    Time frame: 365 days after surgery

    Defined as:

    • Non-cardiovascular death with other defined reason for death
    • Sepsis (sepsis - severe sepsis - septic shock)
    • Pneumonia
    • Respiratory failure
    • Surgical complications (Clavien-Dindo stage 3)
    • Any non-cardiovascular life-threatening complication (Clavien-Dindo stage 4)
    • Readmission due to a non-cardiovascular complication

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Acronym: PHASE

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 29, 2018
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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