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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06662513




Registration number
NCT06662513
Ethics application status
Date submitted
21/10/2024
Date registered
29/10/2024

Titles & IDs
Public title
Post Oesophagectomy Outcomes in a Single Regional Centre in Australia
Scientific title
An Australian Regional Hospital's Oesophagectomy Outcomes
Secondary ID [1] 0 0
2024/ETH01712
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophageal Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No Intervention: Observational Cohort

oesophagectomy - patients who underwent oesophagectomy within the specified time frame


Other interventions: No Intervention: Observational Cohort
No intervention - retrospective observational study
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
mortality
Timepoint [1] 0 0
from date of surgery to end of study (November 2024) for a timeframe up to 10 years
Primary outcome [2] 0 0
Anastomotic leak
Timepoint [2] 0 0
from date of surgery to end of study period (Nov 2024), assessed up to 10 years
Primary outcome [3] 0 0
Length of stay
Timepoint [3] 0 0
from date of surgery to discharge date of hospital admission, approximately 2-4 weeks in most cases but assessed up to 12 weeks

Eligibility
Key inclusion criteria
* patients who underwent oeophagectomy at Launceston General Hospital between January 2014 to December 2023
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* none

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 0 0
7250 - Launceston

Funding & Sponsors
Primary sponsor type
Other
Name
Launceston General Hospital
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Department of Health, Tasmania
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Renishka N Sellayah, MBBS (hons) FRACS
Address 0 0
Country 0 0
Phone 0 0
+61 425 816 462
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06662513