The Association Between Preoperative CPEX and Postoperative Morbidity Following Oesophagectomy

Completed

• Conditions: Oesophageal Cancer

• Registration Number: NCT03216694
• Lead Sponsor: University of East Anglia

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.

Study Timeline

• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-13
• Study Start: 2017-07-21
• Primary Completion: 2017-10-04
• Study Completion: 2018-03-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause postoperative morbidity	30 days	Classified using Esophageal Complications Consensus Group (ECCG) definitions \[1\] and graded using Clavien-Dindo severity classification \[2\].

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Norfolk and Norwich University Hospital; 🇬🇧 Norwich, Norfolk, United Kingdom