Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05483179 |
| Other study ID # |
2022_052a |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2022 |
| Est. completion date |
July 27, 2022 |
Study information
| Verified date |
July 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 two relatively new preoperative submaximal and
effort-independent CPET variables, the cardiopulmonary optimal point (COP) and the Oxyen
uptake efficiency plateau (OUEP) and postoperative outcomes in colorectal cancer surgery.
In additiion, the association between the oxygen uptake at the COP en OUEP and postoperative
outcomes wil be explored.
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 the cardiopulmonary optimal point (COP) and the
oxygen uptake efficiency plateau (OUEP), 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, COP, and OUEP as well as the oxygen uptake at the COP and OUEP 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), COP,
oxygen uptake at the COP, OUEP and and oxygen uptake at the OUEP 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 the
beforementioned CPET variables and 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, 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.
