Operative Procedures, Complications
Conditions
Brief summary
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.
Detailed description
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).
Interventions
None listed
Sponsors
University of Lausanne Hospitals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients over 18 years old * Patients undergoing esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal surgery * Operation time more than 2 hours * Operation including an organ resection for benign or malignant disease
Exclusion criteria
* Immunosuppressive therapy * Cognitive impairment or language comprehension problems * Absence of the consent form prior to first blood sample
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive Value of Postoperative Albumin Decrease in Terms of Surgical Stress and Postoperative Complications | Albumin preoperatively (day -1) and postoperatively (day 1) after surgery | Delta albumin (g/l) before (day -1) and immediately (day 1) after surgery as a predictor of postoperative complications (until 30 days post surgery) |
Countries
Switzerland
Participant flow
Recruitment details
150 inclusions planned 155 patients screened 17 refusals study stopped after 138 inclusions due to long recruitment time
Pre-assignment details
From the 155 patients initially eligible for the study, 17 refused to participate, thus 138 patients were included in the study
Participants by arm
| Arm | Count |
|---|---|
| Major Abdominal Surgery Cohort In this surgical cohort, 4 inflammatory markers were measured: albumin, procalcitonin, CRP and lactate levels | 138 |
| Total | 138 |
Baseline characteristics
| Characteristic | Major Abdominal Surgery Cohort |
|---|---|
| Age, Continuous | 64 years |
| Region of Enrollment Switzerland | 138 participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 138 |
| other Total, other adverse events | 0 / 138 |
| serious Total, serious adverse events | 1 / 138 |
Outcome results
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)
Time frame: Albumin preoperatively (day -1) and postoperatively (day 1) after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Major Abdominal Surgery Cohort | Predictive Value of Postoperative Albumin Decrease in Terms of Surgical Stress and Postoperative Complications | 11.3 g/L | Standard Deviation 5.6 |