An observational study in Surgery--Complications, Acute Illness and Gastrointestinal Disease, sponsored by Zealand University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-22.
Sponsored by Zealand University Hospital · Observational
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.
548 studies on the registry are indexed under Gastrointestinal Diseases; 101 are open to participants now.
This study's enrollment of 98 is below the median of 350 across 147 observational studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Zealand University Hospital is the lead sponsor of 236 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients ≥ 18 years old undergoing acute major gastrointestinal surgery within 72 hours of their admission to the Department of Surgery or an acute reoperation.
Major gastrointestinal surgery are defined as procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction.
Patients will be consecutively screened for inclusion.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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
Changes of immunological biomarkers
Assessment of: * plasma inflammatory interleukines incl. IL-1-alfa, IL-1beta, IL-6, IL-10 * plasma TNF-alfa * plasma TGF-beta
Time frame: Change from preoperative levels at postoperative day 5
Number of patients with stress induced hyperglycemia
Assessment of: * Blood glucose, plasma c-peptide, HbA1C * plasma Glucagon-like peptide 1 (GLP-1)
Time frame: Postoperative day 5
Changes of plasma thyroid hormones
Assessment of: * Thyropin-releasing hormone (TRH) * Thyroid-stimulating hormone (TSH) * Thyroid hormones (fT3, fT4, rT3)
Time frame: Change from preoperative levels at postoperative day 5
Changes of the central endocrine stress response
Assessment of plasma corticotropin releasing hormone (CRH)
Time frame: Change from preoperative levels at postoperative day 5
Changes of sE-selectin
Assessment of plasma sE-selectine * sE-selectin * syndecan-1 * thrombomodulin * sVE-cadherin
Time frame: Change from preoperative levels at postoperative day 5
Changes of the endothelial function
Assessed with the non-invasive EndoPAT and expressed as the reactive hyperemia index
Time frame: Change from postoperative day 1 at postoperative day 5
Changes of the periferal endocrine stress response
Assessment of plasma adrenocorticotropic hormone (ACTH)
Time frame: Change from preoperative levels at postoperative day 5
Changes of cortisol
Assessment of plasma cortisol (free and bound)
Time frame: Change from preoperative levels at postoperative day 5
Changes of neuropeptides
Assessment of plasma neuropeptides
Time frame: Change from preoperative levels at postoperative day 5
Changes of syndecan-1
Assessment of plasma syndecan-1
Time frame: Change from preoperative levels at postoperative day 5
Changes of thrombomodulin
Assessment of plasma thrombomodulin
Time frame: Change from preoperative levels at postoperative day 5
Changes of sVE-cadherin
Assessment of plasma sVE-cadherin
Time frame: Change from preoperative levels at postoperative day 5
Number of patients with major adverse cardiovascular events
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
Time frame: 365 days after surgery
Number of patients with postoperative non-cardiovascular complications
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
Time frame: 365 days after surgery
Ran from Mar 2018 to primary completion in Nov 2018, 7 months.
Of 65 observational studies under Gastrointestinal Diseases, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 155. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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