POETRYabd: Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery

Sponsor

Zealand University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03010969

Collaborator

(none)

224

Enrollment

Location

Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the clinical study is:

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.
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.
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.
to examine the association between postoperative endothelial function, pulmonary function and blood glucose level
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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Complication Complication, Postoperative	Procedure: Acute abdominal surgery

Study Design

Study Type:

Observational

Actual Enrollment :

224 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Nov 1, 2018

Actual Study Completion Date :

Nov 1, 2019

Outcome Measures

Primary Outcome Measures

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 [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
Postoperative non-cardiovascular complications [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 Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Surgery, Zealand University Hospital, Koge	Køge		Denmark	4600

Sponsors and Collaborators

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