Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery (POETRYabd)

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

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.

Study Overview

• Status: Completed
• Conditions: Complication, Postoperative; Cardiovascular Complication
• Intervention / Treatment: Procedure: Acute abdominal surgery

• Study Type: Observational
• Enrollment (Actual): 224

Contacts and Locations

Study Locations

• Denmark
  • Køge, Denmark, 4600
    • Department of Surgery, Zealand University Hospital, Koge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing major acute gastrointestinal surgery

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in reactive hyperemia index assessed by EndoPat		The change from 4-24 hours to between day 3 and 5 after surgery
Major adverse cardiovascular events	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	Within 365 days of surgery
Postoperative non-cardiovascular complications	Non-cardiovascular death, sepsis, pneumonia, respiratory failure, surgical complications (min. Clavien-Dindo stage 3), Any non-cardiovascular life-threatening complication (Clavien-Dindo stage 4).	Within 365 days of surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Nitric oxide biomarkers	4-24 hours after surgery and between postoperative day 3-5
Reactive hyperemia index assessed by EndoPat	4-24 hours after surgery
Reactive hyperemia index assessed by EndoPat	between day 3 and 5 after surgery
Blood Glucose level	Postoperative day 1 - 7 (or until discharge)
Pulmonary function	Postoperative day 1 - 7 (or until discharge)
Readmission	Readmissions within 1 year of discharge
Lengths of stay	Lengths of stay from the operation day to discharge, on average 14 days.
Lengths of stay in the intensive care unit	Lengths of stay from the operation day to discharge from hospital, on average 14 days.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative quality of recovery (QoR15)	QoR15 score	postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
Numerical rating scale (NRS) pain score	NRS pain score in rest and at activity	postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
Post-Traumatic Stress Disorder	Post-Traumatic Stress Disorder questionnaire	postoperative day 14, 30, 90 and 365
Depressive thoughts	Hospital anxiety and depression scale	postoperative day 14, 30, 90 and 365
Postoperative pain	Questionnaire Self-reported Leeds Assessment of Neuropatic Symptoms and Signs pain scale (S-LANSS)	postoperative day 14, 30, 90 and 365
Functional status	Activity Assessment Scale	postoperative day 14, 30, 90 and 365

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Investigators: Principal Investigator: Sarah Ekeloef, MD, Department of Surgery, Zealand University Hospital; Principal Investigator: Jakob Burcharth, MD, Phd., Department of Surgery, Zealand University Hospital

Publications and helpful links

General Publications

• Ekeloef S, Oreskov JO, Falkenberg A, Burcharth J, Schou-Pedersen AMV, Lykkesfeldt J, Gogenur I. Endothelial dysfunction and myocardial injury after major emergency abdominal surgery: a prospective cohort study. BMC Anesthesiol. 2020 Mar 16;20(1):67. doi: 10.1186/s12871-020-00977-0.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 14, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Endothelial dysfunction; Surgery; Pulmonary function; Patient-related outcomes; Blood glucose level
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: POETRY abdominal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share IPD