Association Between New Effort-independent Cardiopulmonary Exercise Test Variables and Postoperative Complications After Elective Colorectal Surgery

NCT05483179 | Completed

• 1 other identifier: 2022_052a
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

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

  30 days postoperative

Secondary Outcomes (1)

• Length of stay

  60 days

Study Arms (1)

Patients with colorectal cancer Patients with colorectal cancer who underwent elective surgery.

Diagnostic Test: Preoperative cardiopulmonary exercise tetsing Patients underwent a cardiopulmonary exercise test prior to surgery.

Diagnostic Test: CPET

Interventions

CPET DIAGNOSTIC_TEST

Cardiopulmonary exercise test

Patients with colorectal cancer Patients with colorectal cancer who underwent elective surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with colorectal cancer stage I-III sceduled for surgery

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

Sponsors & Collaborators

• VieCuri Medical Centre: lead

Study Sites (1)

Viecuri medical center

Venlo, Limburg, 5995BL, Netherlands

Location

MeSH Terms

Conditions

Colorectal 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: July 28, 2022
• First Posted: August 2, 2022
• Study Start: April 15, 2022
• Primary Completion: July 15, 2022
• Study Completion: July 27, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)