The Association Between Preoperative CPEX and Postoperative Morbidity Following Oesophagectomy

April 24, 2019 updated by: University of East Anglia

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

254

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients that underwent oeosphagectomy at the Norfolk and Norwich Hospital between September 2011 to March 2017

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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].
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiopulmonary complications
Time Frame: 30 days
Classified using ECCG definitions and graded using Clavien-Dindo severity classification.
30 days
Non-cardiopulmonary complications
Time Frame: 30 days
Classified using ECCG definitions and graded using Clavien-Dindo severity classification.
30 days
Mortality
Time Frame: 30 days
All cause mortality.
30 days
Mortality
Time Frame: 90 days
All cause mortality.
90 days
Pneumonia
Time Frame: 30 days
Classified using ECCG definitions and graded using Clavien-Dindo severity classification.
30 days
Atrial fibrillation
Time Frame: 30 days
Classified using ECCG definitions and graded using Clavien-Dindo severity classification.
30 days
Anastomotic leak
Time Frame: 30 days
Classified using ECCG definitions and graded using Clavien-Dindo severity classification.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of East Anglia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2017

Primary Completion (Actual)

October 4, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

July 12, 2017

First Posted (Actual)

July 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 222793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oesophageal Cancer

Clinical Trials on Cardiopulmonary exercise testing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe