Department of Surgery, Zealand University Hospital, Koge
Køge, 4600, Denmark
NCT Number: NCT03010969
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.
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Notify Me18 year and older
All sexes
Observational
Køge, 4600, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Acute abdominal surgery within 72 hours of admission to the department of surgery
Time frame: The change from 4-24 hours to between day 3 and 5 after surgery
Time frame: Within 365 days of surgery
Time frame: 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).
Time frame: 4-24 hours after surgery and between postoperative day 3-5
Time frame: 4-24 hours after surgery
Time frame: between day 3 and 5 after surgery
Time frame: Postoperative day 1 - 7 (or until discharge)
Time frame: Postoperative day 1 - 7 (or until discharge)
Time frame: Readmissions within 1 year of discharge
Time frame: Lengths of stay from the operation day to discharge, on average 14 days.
Time frame: Lengths of stay from the operation day to discharge from hospital, on average 14 days.
Time frame: postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
QoR15 score
Time frame: postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
NRS pain score in rest and at activity
Time frame: postoperative day 14, 30, 90 and 365
Post-Traumatic Stress Disorder questionnaire
Time frame: postoperative day 14, 30, 90 and 365
Hospital anxiety and depression scale
Time frame: postoperative day 14, 30, 90 and 365
Questionnaire Self-reported Leeds Assessment of Neuropatic Symptoms and Signs pain scale (S-LANSS)
Time frame: postoperative day 14, 30, 90 and 365
Activity Assessment Scale
Zealand University Hospital
Other
Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery. The POETRY Abdominal Study
Acronym: POETRYabd
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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