NCT05331196

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

April 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

November 23, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

April 8, 2022

Last Update Submit

November 22, 2022

Conditions

Keywords

Cardiopulmonary exercise testingprehabilitationOUES

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    Postoperative complications scored using Clavien-Dindo clasification gade (1-5)

    30 days postoperative

Secondary Outcomes (2)

  • Length of stay

    60 days

  • Readmissions

    30 days postoperative

Study Arms (1)

Patients with colorectal cancer

Patients with colorectal cancer who underwent elective surgery.

Diagnostic Test: Preoperative cardiopulmonary exercise tetsing

Interventions

Patients underwent a cardiopulmonary exercise test prior to surgery.

Patients with colorectal cancer

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with colorectal cancer stage I-III who underwent elective surgery in in Medisch Spectrum Twente (MST) Maxima Medical Center (MMC), Maastricht University Medical Center (MUMC), VieCuri Medical Center (VMC) and underwent preoperative CPET.

You may qualify if:

  • Patients who had a preoperative CPET and who underwent elective colorectal surgery and where, \> 18 years (MMC, VMC) or ≥60 years (MST), with a score ≤7 metabolic equivalents on the veterans-specific activity questionnaire (MST, MUMC+,VMC).

You may not qualify if:

  • Patients who participated in exercise prehabilitation prior to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Viecuri medical center

Venlo, Limburg, 5995BL, Netherlands

Location

Related Publications (1)

  • Franssen RFW, Berkel AEM, Ten Cate DWG, van der Palen J, van Meeteren NLU, Vogelaar FJ, Slooter G, Klaase JM, Janssen-Heijnen MLG, Bongers BC. A retrospective analysis of the association of effort-independent cardiopulmonary exercise test variables with postoperative complications in patients who underwent elective colorectal surgery. Langenbecks Arch Surg. 2023 Dec 14;409(1):7. doi: 10.1007/s00423-023-03197-5.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal 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 15, 2022

Study Start

April 15, 2022

Primary Completion

July 15, 2022

Study Completion

October 15, 2022

Last Updated

November 23, 2022

Record last verified: 2022-08

Locations