Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery

Cardiovascular Complication Clinical Trial

— POETRYabd  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010969
• Other study ID #: POETRY abdominal
• Status: Completed
• Start date: October 2016
• Est. completion date: November 2019

Study information

• Verified date: February 2021
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: November 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Complication
• Complication, Postoperative
• Postoperative Complications

Intervention

Procedure:
• Acute abdominal surgery
Acute abdominal surgery within 72 hours of admission to the department of surgery

Locations

Country	Name	City	State
Denmark	Department of Surgery, Zealand University Hospital, Koge	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative quality of recovery (QoR15)	QoR15 score	postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
Other	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
Other	Post-Traumatic Stress Disorder	Post-Traumatic Stress Disorder questionnaire	postoperative day 14, 30, 90 and 365
Other	Depressive thoughts	Hospital anxiety and depression scale	postoperative day 14, 30, 90 and 365
Other	Postoperative pain	Questionnaire Self-reported Leeds Assessment of Neuropatic Symptoms and Signs pain scale (S-LANSS)	postoperative day 14, 30, 90 and 365
Other	Functional status	Activity Assessment Scale	postoperative day 14, 30, 90 and 365
Primary	The change in reactive hyperemia index assessed by EndoPat		The change from 4-24 hours to between day 3 and 5 after surgery
Primary	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
Primary	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	Nitric oxide biomarkers		4-24 hours after surgery and between postoperative day 3-5
Secondary	Reactive hyperemia index assessed by EndoPat		4-24 hours after surgery
Secondary	Reactive hyperemia index assessed by EndoPat		between day 3 and 5 after surgery
Secondary	Blood Glucose level		Postoperative day 1 - 7 (or until discharge)
Secondary	Pulmonary function		Postoperative day 1 - 7 (or until discharge)
Secondary	Readmission		Readmissions within 1 year of discharge
Secondary	Lengths of stay		Lengths of stay from the operation day to discharge, on average 14 days.
Secondary	Lengths of stay in the intensive care unit		Lengths of stay from the operation day to discharge from hospital, on average 14 days.