Cardiopulmonary Exercise Test Data Averaging Methods and Preoperative Risk Assessment

NCT05353127 | Completed

• 1 other identifier: 2022_053
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiopulmonary exercise testing (CPET) is used for preoperative risk assessment in patients with colorectal cancer who need to undergo surgery. For presentation and interpretation purposes, CPET data are averaged by using a time- or breath-based average. It is uncertain to what extent differences in data averaging methods influence the numerical value of preoperative CPET-derived variables used for risk assessment. Therefore, the primary aim of this study is to investigate the influence of different CPET data averaging intervals on the numerical values of CPET-derived variables used for preoperative risk assessment in patients scheduled for elective colorectal cancer surgery. The secondary aim is to elucidate the impact of data-averaging intervals on classification of patients into a low- or high-risk category for postoperative complications based on known risk assessment thresholds.

Conditions

Colorectal Cancer; Surgery; Colorectal Neoplasms Malignant

Keywords

colorectal surgery; Prehabilitation; CPET; CardioPulmonary Exercise Testing

Outcome Measures

Primary Outcomes (6)

• Influence of different CPET data averaging intervals on the numerical values of CPET-derived variables.

  To assess the influence of different CPET data averaging intervals on the numerical the numerical values of VO2VAT,

  Baseline, pre surgery

• Influence of different CPET data averaging intervals on the numerical values of CPET-

  To assess the influence of different CPET data averaging intervals on the numerical the numerical values of VO2peak.

  Baseline, pre surgery

• Influence of different CPET data averaging intervals on the numerical values of CPET-

  To assess the influence of different CPET data averaging intervals on the numerical the numerical values of VE/VCO2-slope.

  Baseline, pre surgery

• Influence of different CPET data averaging intervals on the numerical values of CPET-

  To assess the influence of different CPET data averaging intervals on the numerical the numerical values of RERpeak.

  Baseline, pre surgery

• Influence of different CPET data averaging intervals on the numerical values of CPET-

  To assess the influence of different CPET data averaging intervals on the numerical the numerical values of VE/VCO2VAT.

  Baseline, pre surgery

• Influence of different CPET data averaging intervals on the numerical values of CPET-

  To assess the influence of different CPET data averaging intervals on the numerical the numerical values of the OUES.

  Baseline, pre surgery

Secondary Outcomes (1)

• High- or Low-risk for postoperative complications

  Baseline, pre surgery

Study Arms (1)

Patiënts who underwent a CPET prior to elective colorectal surgery investigate fitness level.

Patients considered for colorectal cancer surgery who were ≥18 years of age, had a score ≤7 metabolic equivalents of task on the veterans-specific activity questionnaire.

Diagnostic Test: CPET/Cardiopulmonary Exercise Test

Interventions

CPET/Cardiopulmonary Exercise Test DIAGNOSTIC_TEST

During CPET, a patient exercises against a progressively increasing work rate until volitional exhaustion, while breath-by-breath respiratory gasses are analyzed.

Patiënts who underwent a CPET prior to elective colorectal surgery investigate fitness level.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients considered for colorectal cancer surgery at the VieCuri Medical Centre Venlo, who had undergone a preoperative CPET before colorectal surgery as a part of a prehabilitation study.

You may qualify if:

• Patiënts with colorectal cancer, considered for surgery.
• A score of ≤7 metabolic equivalents of task on the veterans-specific activity questionnaire and therefore performed preoperative CPET as a part of a prehabilitation study

You may not qualify if:

• Patiënt unable to perform CPET.

Sponsors & Collaborators

• VieCuri Medical Centre: lead

Study Sites (1)

Viecuri Medical Center

Venlo, Limburg, 5912BL, Netherlands

Location

Related Publications (1)

• Franssen RFW, Sanders BHE, Takken T, Vogelaar FJ, Janssen-Heijnen MLG, Bongers BC. Influence of different data-averaging methods on mean values of selected variables derived from preoperative cardiopulmonary exercise testing in patients scheduled for colorectal surgery. PLoS One. 2023 Mar 16;18(3):e0283129. doi: 10.1371/journal.pone.0283129. eCollection 2023.

  PMID: 36928094 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 29, 2022
• Study Start: April 12, 2022
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-04

Locations

NL (1)