The Association Between Preoperative CPEX and Postoperative Morbidity Following Oesophagectomy

Oesophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03216694
• Other study ID #: 222793
• Status: Completed
• Start date: July 21, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: April 2019
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: March 1, 2018
• Est. primary completion date: October 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Oesophageal Cancer

Intervention

Diagnostic Test:
• Cardiopulmonary exercise testing
Aerobic fitness measured using a cycle ergometer and metabolic cart

Locations

Country	Name	City	State
United Kingdom	Norfolk and Norwich University Hospital	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause postoperative morbidity	Classified using Esophageal Complications Consensus Group (ECCG) definitions [1] and graded using Clavien-Dindo severity classification [2].	30 days
Secondary	Cardiopulmonary complications	Classified using ECCG definitions and graded using Clavien-Dindo severity classification.	30 days
Secondary	Non-cardiopulmonary complications	Classified using ECCG definitions and graded using Clavien-Dindo severity classification.	30 days
Secondary	Mortality	All cause mortality.	30 days
Secondary	Mortality	All cause mortality.	90 days
Secondary	Pneumonia	Classified using ECCG definitions and graded using Clavien-Dindo severity classification.	30 days
Secondary	Atrial fibrillation	Classified using ECCG definitions and graded using Clavien-Dindo severity classification.	30 days
Secondary	Anastomotic leak	Classified using ECCG definitions and graded using Clavien-Dindo severity classification.	30 days

External Links

•   [1]
•   [2]