The Association Between Preoperative CPEX and Postoperative Morbidity Following Oesophagectomy

NCT ID: NCT03216694

Last Updated: 2019-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

254 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-21

Study Completion Date

2018-03-01

Brief Summary

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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

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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.

Conditions

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Oesophageal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Cardiopulmonary exercise testing

Aerobic fitness measured using a cycle ergometer and metabolic cart

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of East Anglia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Norfolk and Norwich University Hospital

Norwich, Norfolk, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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Other Identifiers

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222793

Identifier Type: -

Identifier Source: org_study_id

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