The Association Between Preoperative CPEX and Postoperative Morbidity Following Oesophagectomy

• Sponsor: University of East Anglia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03216694
• Collaborator: (none)
• Enrollment: 254
• Location: 1
• Actual Duration (Months): 7.3
• Patients Per Site Per Month: 34.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oesophageal Cancer	Diagnostic Test: Cardiopulmonary exercise testing

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 Design

• Study Type: Observational
• Actual Enrollment: 254 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The Association Between Preoperative Cardiopulmonary Exercise Test Variables and Short-term Postoperative Morbidity Following Oesophagectomy: a Hospital-based Cohort Study
• Actual Study Start Date: Jul 21, 2017
• Actual Primary Completion Date: Oct 4, 2017
• Actual Study Completion Date: Mar 1, 2018

Outcome Measures

Primary Outcome Measures

1. 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

1. Cardiopulmonary complications [30 days]

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

2. Non-cardiopulmonary complications [30 days]

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

3. Mortality [30 days]

   All cause mortality.

4. Mortality [90 days]

   All cause mortality.

5. Pneumonia [30 days]

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

6. Atrial fibrillation [30 days]

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

7. Anastomotic leak [30 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. male and female ii. underwent an oesophagectomy iii. completed a pre-operative CPEX test

Exclusion Criteria:

1. patients that were unable to complete a full CPEX test ii. emergency or palliative surgery iii. pharyngolaryngo-oesophagectomy iv. oesophagectomy and gastrectomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Norfolk and Norwich University Hospital	Norwich	Norfolk	United Kingdom	NR4 7UY

Sponsors and Collaborators

• University of East Anglia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• [1]
• [2]

Publications

None provided.

• Responsible Party: University of East Anglia
• ClinicalTrials.gov Identifier: NCT03216694
• Other Study ID Numbers: 222793
• First Posted: Jul 13, 2017
• Last Update Posted: Apr 25, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 25, 2019