Clinical trial NCT03010969: Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery
Official title: Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery. The POETRY Abdominal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Complication
Complication, Postoperative
Keywords: Endothelial dysfunction
Surgery
Pulmonary function
Blood glucose level
Patient-related outcomes
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing major acute gastrointestinal surgery

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The change in reactive hyperemia index assessed by EndoPat
timeFrame: The change from 4-24 hours to between day 3 and 5 after surgery
measure: Major adverse cardiovascular events
timeFrame: Within 365 days of surgery
measure: Postoperative non-cardiovascular complications
timeFrame: Within 365 days of surgery
Secondary outcomes:
measure: Nitric oxide biomarkers
timeFrame: 4-24 hours after surgery and between postoperative day 3-5
measure: Reactive hyperemia index assessed by EndoPat
timeFrame: 4-24 hours after surgery
measure: Reactive hyperemia index assessed by EndoPat
timeFrame: between day 3 and 5 after surgery
measure: Blood Glucose level
timeFrame: Postoperative day 1 - 7 (or until discharge)
measure: Pulmonary function
timeFrame: Postoperative day 1 - 7 (or until discharge)
measure: Readmission
timeFrame: Readmissions within 1 year of discharge
measure: Lengths of stay
timeFrame: Lengths of stay from the operation day to discharge, on average 14 days.
measure: Lengths of stay in the intensive care unit
timeFrame: Lengths of stay from the operation day to discharge from hospital, on average 14 days.
Other outcomes:
measure: Postoperative quality of recovery (QoR15)
timeFrame: postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
measure: Numerical rating scale (NRS) pain score
timeFrame: postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
measure: Post-Traumatic Stress Disorder
timeFrame: postoperative day 14, 30, 90 and 365
measure: Depressive thoughts
timeFrame: postoperative day 14, 30, 90 and 365
measure: Postoperative pain
timeFrame: postoperative day 14, 30, 90 and 365
measure: Functional status
timeFrame: postoperative day 14, 30, 90 and 365
Locations:
city: Køge
country: Denmark
facility: Department of Surgery, Zealand University Hospital, Koge
Study officials:
affiliation: Department of Surgery, Zealand University Hospital
name: Sarah Ekeloef, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, Zealand University Hospital
name: Jakob Burcharth, MD, Phd.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.