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The Association Between Preoperative CPEX and Postoperative Morbidity Following Oesophagectomy

The Association Between Preoperative Cardiopulmonary Exercise Test Variables and Short-term Postoperative Morbidity Following Oesophagectomy: a Hospital-based Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03216694
Enrollment
254
Registered
2017-07-13
Start date
2017-07-21
Completion date
2018-03-01
Last updated
2019-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oesophageal Cancer

Brief summary

A retrospective hospital-based cohort study of the association between preoperative cardiopulmonary exercise test (CPEX) variables and short-term postoperative morbidity following oesophagectomy.

Detailed description

The aim of this study is to examine the correlations between preoperative CPEX variables (VO2max and Anaerobic Threshold) and 30 day postoperative all cause morbidity in a sample large enough to allow (should significant associations exist) calculation of a threshold value. Secondary aims are to examine associations between the VO2max, AT and cardiopulmonary, non-cardiopulmonary complications as well as specific complications (atrial fibrillation, pneumonia, and anastomotic leak) as well as 30 and 90 day mortality.

Interventions

DIAGNOSTIC_TESTCardiopulmonary exercise testing

Aerobic fitness measured using a cycle ergometer and metabolic cart

Sponsors

University of East Anglia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

i. male and female ii. underwent an oesophagectomy iii. completed a pre-operative CPEX test

Exclusion criteria

i. patients that were unable to complete a full CPEX test ii. emergency or palliative surgery iii. pharyngolaryngo-oesophagectomy iv. oesophagectomy and gastrectomy

Design outcomes

Primary

MeasureTime frameDescription
All cause postoperative morbidity30 daysClassified using Esophageal Complications Consensus Group (ECCG) definitions \[1\] and graded using Clavien-Dindo severity classification \[2\].

Secondary

MeasureTime frameDescription
Non-cardiopulmonary complications30 daysClassified using ECCG definitions and graded using Clavien-Dindo severity classification.
Mortality30 daysAll cause mortality.
Cardiopulmonary complications30 daysClassified using ECCG definitions and graded using Clavien-Dindo severity classification.
Atrial fibrillation30 daysClassified using ECCG definitions and graded using Clavien-Dindo severity classification.
Anastomotic leak30 daysClassified using ECCG definitions and graded using Clavien-Dindo severity classification.
Pneumonia30 daysClassified using ECCG definitions and graded using Clavien-Dindo severity classification.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026