Cardiovascular Complication, Complication, Postoperative
Conditions
Keywords
Endothelial dysfunction, Surgery, Pulmonary function, Blood glucose level, Patient-related outcomes
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.
Interventions
PROCEDUREAcute abdominal surgery
Acute abdominal surgery within 72 hours of admission to the department of surgery
Sponsors
Zealand University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in reactive hyperemia index assessed by EndoPat | The change from 4-24 hours to between day 3 and 5 after surgery | — |
| 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). |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Blood Glucose level | Postoperative day 1 - 7 (or until discharge) |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Depressive thoughts | postoperative day 14, 30, 90 and 365 | Hospital anxiety and depression scale |
| Post-Traumatic Stress Disorder | postoperative day 14, 30, 90 and 365 | Post-Traumatic Stress Disorder questionnaire |
| 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 |
Countries
Denmark
Outcome results
None listed