Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to evaluate the predictive value of albumine, C-reactive protein (CRP), procalcitonin, and lactates in terms of surgical stress and postoperative complications. These biomarkers will be measured from the day before surgery until postoperative day four in patients undergoing major surgery. Major surgery was defined as esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal procedures including an organ resection for benign or malignant disease and lasting more than 2 hours.
This prospective study was conducted at the Department for Visceral Surgery at the University Hospital of Lausanne Switzerland (CHUV) between February and December 2015 (NCT02356484). The study was approved by the Institutional Review Board (No. 367/15), and all patients provided written consent prior to surgery. Inclusion criteria were age >18 years, and elective major abdominal surgery-defined as an operative procedure with anticipated duration ≥2 hours.17 Perioperative care closely adhered to recently published enhanced recovery guidelines (http://erassociety.org.loopiadns.com/guidelines/list-of-guidelines). Standardised fluid administration was followed by advanced haemodynamic monitoring to avoid intraoperative fluid overload. According to the clinical care pathway, intravenous fluid was typically discontinued the morning after surgery.
Biological markers Serum levels of albumin, CRP, PCT and lactate (LCT) were perioperatively measured in a fasting state, Following standardised institutional guidelines. Blood samples were drawn the day before surgery, the day of surgery (4-6 hours after the end of the operation) and on the first, second and third postoperative day. As Baseline values tend to show large variations especially for albumin,4 10 we considered that a dynamic value (difference between two time-points) might be more informative than a snapshot value. Several values based on preoperative and postoperative concentrations were thus calculated for each marker (ie, Δ Max: maximal difference between the preoperative and postoperative values; Δ POD 0: difference of concentration on POD -1 and POD 0; Δ POD 1: difference of concentration on POD-1 and POD 1).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Major abdominal surgery cohort | In this surgical cohort, 4 inflammatory markers were measured: albumin, procalcitonin, CRP and lactate levels |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Predictive Value of Postoperative Albumin Decrease in Terms of Surgical Stress and Postoperative Complications | Delta albumin (g/l) before (day -1) and immediately (day 1) after surgery as a predictor of postoperative complications (until 30 days post surgery) | Albumin preoperatively (day -1) and postoperatively (day 1) after surgery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients undergoing major surgery (esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal surgery)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martin Hübner, MD | University of Lausanne Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Lausanne Hospital | Lausanne | Canton of Vaud | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28391235 | Derived | Labgaa I, Joliat GR, Kefleyesus A, Mantziari S, Schafer M, Demartines N, Hubner M. Is postoperative decrease of serum albumin an early predictor of complications after major abdominal surgery? A prospective cohort study in a European centre. BMJ Open. 2017 Apr 8;7(4):e013966. doi: 10.1136/bmjopen-2016-013966. |
Not provided
Not provided
From the 155 patients initially eligible for the study, 17 refused to participate, thus 138 patients were included in the study
150 inclusions planned 155 patients screened 17 refusals study stopped after 138 inclusions due to long recruitment time
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Major Abdominal Surgery Cohort | One-arm study including all patients undergoing "major abdominal surgery according to the provided definition. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Major Abdominal Surgery Cohort | In this surgical cohort, 4 inflammatory markers were measured: albumin, procalcitonin, CRP and lactate levels |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Predictive Value of Postoperative Albumin Decrease in Terms of Surgical Stress and Postoperative Complications | Delta albumin (g/l) before (day -1) and immediately (day 1) after surgery as a predictor of postoperative complications (until 30 days post surgery) | Posted | Mean | Standard Deviation | g/L | Albumin preoperatively (day -1) and postoperatively (day 1) after surgery |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Major Abdominal Surgery Cohort | Patients undergoing major abdominal surgery according to the provided definition |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiorespiratory arrest | Cardiac disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr. Nicolas Demartines | Lausanne University Hospital | 0041213142424 | demartines@chuv.ch |
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | demographical data such as patient gender were recorded | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 1 |
| 138 |
| 1 |
| 138 |
| 0 |
| 138 |
Not provided
Not provided
Not provided