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The aim of the clinical study is:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute abdominal surgery | Procedure | Acute abdominal surgery within 72 hours of admission to the department of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative quality of recovery (QoR15) | QoR15 score | postoperative day 1, 3, 5, 7, 14, 30, 90 and 365 |
| Numerical rating scale (NRS) pain score | NRS pain score in rest and at activity |
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
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Patients undergoing major acute gastrointestinal surgery
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Ekeloef, MD | Department of Surgery, Zealand University Hospital | Principal Investigator |
| Jakob Burcharth, MD, Phd. | Department of Surgery, Zealand University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Zealand University Hospital, Koge | Køge | 4600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32178626 | Derived | 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. |
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We do not plan to share IPD
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The blood will be collected from a larger vein (e.g. the cubital vein). Cardiac troponin I Tetrahydrobiopterin: Blood is sampled into 4mL EDTA tubes. Immediately after withdrawal, a minimum of 1mL blood is mixed with 25μL DTE. The mixture is centrifuged at 2000g for 5 minutes. Plasma is frozen and stored at -80°C.
Arginine and ADMA: Blood is sampled into 4mL EDTA tubes. Blood samples will be centrifuged at 3000g for 10 minutes, plasma frozen and stored at -80°C until analyzed with high performance liquid chromatography.
| 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. |
| postoperative day 1, 3, 5, 7, 14, 30, 90 and 365 |
| Post-Traumatic Stress Disorder | Post-Traumatic Stress Disorder questionnaire | postoperative day 14, 30, 90 and 365 |
| Depressive thoughts | Hospital anxiety and depression scale | postoperative day 14, 30, 90 and 365 |
| Postoperative pain | Questionnaire Self-reported Leeds Assessment of Neuropatic Symptoms and Signs pain scale (S-LANSS) | postoperative day 14, 30, 90 and 365 |
| Functional status | Activity Assessment Scale | postoperative day 14, 30, 90 and 365 |