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NCT Number: NCT03216694

The Association Between Preoperative CPEX and Postoperative Morbidity Following Oesophagectomy

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

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Key information

Conditions

Oesophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

Norfolk and Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiopulmonary exercise testing

Diagnostic Test

Aerobic fitness measured using a cycle ergometer and metabolic cart

Primary outcomes

  1. All cause postoperative morbidity

    Time frame: 30 days

    Classified using Esophageal Complications Consensus Group (ECCG) definitions [1] and graded using Clavien-Dindo severity classification [2].

Secondary outcomes

  1. Cardiopulmonary complications

    Time frame: 30 days

    Classified using ECCG definitions and graded using Clavien-Dindo severity classification.

  2. Non-cardiopulmonary complications

    Time frame: 30 days

    Classified using ECCG definitions and graded using Clavien-Dindo severity classification.

  3. Mortality

    Time frame: 30 days

    All cause mortality.

  4. Mortality

    Time frame: 90 days

    All cause mortality.

  5. Pneumonia

    Time frame: 30 days

    Classified using ECCG definitions and graded using Clavien-Dindo severity classification.

  6. Atrial fibrillation

    Time frame: 30 days

    Classified using ECCG definitions and graded using Clavien-Dindo severity classification.

  7. Anastomotic leak

    Time frame: 30 days

    Classified using ECCG definitions and graded using Clavien-Dindo severity classification.

Sponsors and collaborators

Lead sponsor

University of East Anglia

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 13, 2017
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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