NCT03216694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

July 21, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 25, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

July 11, 2017

Last Update Submit

April 24, 2019

Conditions

Oesophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • All cause postoperative morbidity

    Classified using Esophageal Complications Consensus Group (ECCG) definitions \[1\] and graded using Clavien-Dindo severity classification \[2\].

    30 days

Secondary Outcomes (7)

  • Cardiopulmonary complications

    30 days

  • Non-cardiopulmonary complications

    30 days

  • Mortality

    30 days

  • Mortality

    90 days

  • Pneumonia

    30 days

  • +2 more secondary outcomes

Interventions

Cardiopulmonary exercise testingDIAGNOSTIC_TEST

Aerobic fitness measured using a cycle ergometer and metabolic cart

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norfolk and Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2017

First Posted

July 13, 2017

Study Start

July 21, 2017

Primary Completion

October 4, 2017

Study Completion

March 1, 2018

Last Updated

April 25, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)