Skip to main content
OpenTrials
Completed

NCT Number: NCT03010969

Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery

The aim of the clinical study is:

1. to examine the association between postoperative endothelial function, indirectly measured by reactive hyperemia index, and major adverse cardiovascular events including myocardial injury and cardiac death within 30, 90 and 365 days of acute abdominal surgery. 2. to examine the association between postoperative endothelial function, indirectly measured by reactive hyperemia index, and non-cardiovascular complications including non-cardiac death within 30, 90 and 365 days of acute abdominal surgery. 3. to examine the importance of the postoperative blood glucose level and the pulmonary function for postoperative complications and death within 30, 90 and 365 days of acute abdominal surgery. 4. to examine the association between postoperative endothelial function, pulmonary function and blood glucose level 5. the qualitative part of the study will examine the postoperative subjective symptoms including acute and chronic pain, quality of recovery and functional status, depressive thoughts and post-traumatic stress disorder.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery, Zealand University Hospital, Koge

Køge, 4600, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥ 18 years old
  • Surgery within 72 hours of an acute admission to the Department of Surgery or an acute reoperation.
  • Major gastrointestinal surgery on the gastrointestinal tract. This will include
  • 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
  • Washout/evacuation of intra-peritoneal abscess (unless due to appendicitis or cholecystitis - excluded, see below)
  • Washout/evacuation of intra-peritoneal hematoma
  • Bowel resection/repair due to incarcerated umbilical, inguinal and femoral hernias (but not hernia repair without bowel resection/repair)
  • Bowel resection/repair due to obstructing/incarcerated incisional hernias provided the presentation and findings were acute
  • Laparotomy/laparoscopy with inoperable pathology (e.g. peritoneal/hepatic metastases)
  • Laparoscopic/Open Adhesiolysis
  • Return to theatre for repair of fascial dehiscence
  • Any reoperation/return to theatre meeting the criteria above is included

If multiple procedures (primary surgery or reoperation) are performed on different anatomical sites within the abdominal/pelvic cavity, the patient would be included if the major procedure is general surgical.

Exclusion criteria

  • Not capable of giving informed consent after oral and written information
  • Previously included in the trial
  • If transferred directly from the operation room or recovery ward to the intensive care unit
  • 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 of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract
  • Cholecystectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract (All surgery involving the appendix or gallbladder, including any surgery relating to complications such as abscess or bile leak is excluded)
  • 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
  • Laparotomy/laparoscopy for esophageal pathology Laparotomy/laparoscopy for pathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract

Treatment and study plan

Acute abdominal surgery

Procedure

Acute abdominal surgery within 72 hours of admission to the department of surgery

Primary outcomes

  1. The change in reactive hyperemia index assessed by EndoPat

    Time frame: The change from 4-24 hours to between day 3 and 5 after surgery

  2. Major adverse cardiovascular events

    Time frame: Within 365 days of surgery

    • Cardiovascular death
    • Myocardial injury within postoperative day 3 (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
  3. Postoperative non-cardiovascular complications

    Time frame: Within 365 days of surgery

    Non-cardiovascular death, sepsis, pneumonia, respiratory failure, surgical complications (min. Clavien-Dindo stage 3), Any non-cardiovascular life-threatening complication (Clavien-Dindo stage 4).

Secondary outcomes

  1. Nitric oxide biomarkers

    Time frame: 4-24 hours after surgery and between postoperative day 3-5

  2. Reactive hyperemia index assessed by EndoPat

    Time frame: 4-24 hours after surgery

  3. Reactive hyperemia index assessed by EndoPat

    Time frame: between day 3 and 5 after surgery

  4. Blood Glucose level

    Time frame: Postoperative day 1 - 7 (or until discharge)

  5. Pulmonary function

    Time frame: Postoperative day 1 - 7 (or until discharge)

  6. Readmission

    Time frame: Readmissions within 1 year of discharge

  7. Lengths of stay

    Time frame: Lengths of stay from the operation day to discharge, on average 14 days.

  8. Lengths of stay in the intensive care unit

    Time frame: Lengths of stay from the operation day to discharge from hospital, on average 14 days.

Other outcomes

  1. Postoperative quality of recovery (QoR15)

    Time frame: postoperative day 1, 3, 5, 7, 14, 30, 90 and 365

    QoR15 score

  2. Numerical rating scale (NRS) pain score

    Time frame: postoperative day 1, 3, 5, 7, 14, 30, 90 and 365

    NRS pain score in rest and at activity

  3. Post-Traumatic Stress Disorder

    Time frame: postoperative day 14, 30, 90 and 365

    Post-Traumatic Stress Disorder questionnaire

  4. Depressive thoughts

    Time frame: postoperative day 14, 30, 90 and 365

    Hospital anxiety and depression scale

  5. Postoperative pain

    Time frame: postoperative day 14, 30, 90 and 365

    Questionnaire Self-reported Leeds Assessment of Neuropatic Symptoms and Signs pain scale (S-LANSS)

  6. Functional status

    Time frame: postoperative day 14, 30, 90 and 365

    Activity Assessment Scale

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery. The POETRY Abdominal Study

Acronym: POETRYabd

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jan 5, 2017
Registry last updated
Feb 17, 2021

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.

Published trials that share one or more normalized conditions with this study.