Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05331196 |
| Other study ID # |
2022_052 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2022 |
| Est. completion date |
October 15, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
VieCuri Medical Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
A cardiopulmonary exercise test (CPET) is increasingly used for preoperative risk assessment.
Oxygen uptake (VO2) at peak exercise (VO2peak) and VO2 at the ventilatory anaerobic threshold
(VO2VAT) are the most commonly used preoperative CPET variables that are associated with
postoperative outcomes following colorectal cancer surgery. The aim of this study is to
investigate the association between preoperative submaximal and effort-independent CPET
variables and postoperative outcomes in colorectal cancer surgery. Specifically, the slope of
the relation between minute ventilation and carbon dioxide production (VE/VCO2-slope) and the
oxygen uptake efficiency slope (OUES) will be investigated.
Description:
After resection for colorectal carcinoma, >30% of the patients develop a complication during
admission or within 30 days after surgery. Several studies indicate that preoperative aerobic
fitness, as objectively measured by a maximal cardiopulmonary exercise test, is associated
with postoperative complications, in which a lower aerobic fitness indicates a higher risk
for complications. The most used CPET variables, oxygen uptake (VO2) at peak exercise
(VO2peak) and VO2 at the ventilatory anaerobic threshold (VO2VAT), have specific limitations.
For a valid VO2peak, a maximal effort is required and VO2VAT determination is subjective and
cannot be determined in all patients. Therefore, this study aims to explore the association
of submaximal (effort-independent) preoperative CPET variables that are determinable in all
patients, specifically the relation between minute ventilation and carbon dioxide production
(VE/VCO2-slope) and the oxygen uptake efficiency slope (OUES), and postoperative outcomes in
patient undergoing colorectal surgery.
Participants An explorative study will be carried out using retrospectively collected data
from patients who underwent preoperative CPET in Medisch Spectrum Twente (MST), Máxima
Medical Center (MMC), Maastricht University Medical Center+ (MUMC+), and VieCuri Medical
Center (VMC).
Patient characteristics and outcome measures The following baseline patient characteristics
will be collected: sex, age, body height, body mass, body mass index (BMI), nutritional
status assessed by the short nutritional assessment questionnaire (SNAQ) score, smoking
status (current, former, never), use of beta-blocker (yes/no), veterans-specific activity
questionnaire score, location, type and stage of the tumor, American Society of
Anesthesiologists (ASA) score (I-IV), Charlson comorbidity index (divided into three groups:
0, 1, and 2+), and type of surgical resection.
CPET data will be interpreted by two trained and experienced clinical exercise physiologists.
The variables VO2peak, VO2VAT, VE-VCO2-slope, and OUES will be determined.
Outcome measures of interest are postoperative complications within 30 days after surgery and
length of hospital stay. The severity of any postoperative complication will be scored using
the Clavien-Dindo classification of complications (grade 1-5). A postoperative complication
is defined as a Clavien-Dindo grade of 1 or higher. A grade 3-5 complication is defined as a
severe complication.
Statistical analysis Receiver operator curve (ROC) analysis will be used to assess the
independent ability of the VO2peak (mL/kg/min), VO2VAT (mL/kg/min), VE/VCO2-slope, and OUES
normalized for body mass (OUES/kg) to discriminate between patients with and without 30-day
postoperative complications. The optimal cut-off point is based on our preference to have
primarily a high sensitivity (>0.8) with a reasonable specificity (>0.5), as we aim to detect
almost all high-risk patients that might benefit from a preoperative intervention (e.g.,
exercise prehabilitation). Forward stepwise multivariable logistic regression analyses will
be performed to investigate the prognostic value of VO2peak, VO2VAT, VE/VCO2-slope, and
OUES/kg for 30-day postoperative complications separately for all complications
(Clavien-Dindo grade of 1 or higher) and severe complication (Clavien-Dindo grade of 3-5). In
case the baseline demographics are associated with 30-day postoperative complications
(p<0.200), they will be tested for their association with VO2peak, VO2VAT, VE/VCO2-slope, and
OUES/kg (p<0.200) using Pearson's r or Spearman's rho correlation coefficients, or paired
sample t-tests, Mann Whitney U test, or one-way ANOVA, as appropriate. The logistic
regression models will be adjusted for the potential confounders in a forward stepwise
procedure.
Based on the optimal cut of points extracted from the ROC curves for each CPET variable,
Kaplan-Meijer curves will be constructed to evaluate the univariate relationship between
VO2peak, VO2VAT, VE/VCO2-slope, and OUES/kg and length of hospital stay. The Log-rank test
will be used to compare survival curves.
Data will be analyzed with the Statistical Package for the Social Sciences for Windows
(version 23.0; IBM, SPSS Inc., Chicago, IL, USA). Continuous data will be presented as mean
with standard deviation, or as median with interquartile range (IQR), as appropriate.
Categorical data will be summarized by frequency and percentage. A p-value <0.05 will be
considered statistically significant.
