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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06721715




Registration number
NCT06721715
Ethics application status
Date submitted
2/12/2024
Date registered
6/12/2024
Date last updated
6/12/2024

Titles & IDs
Public title
Textbook Outcomes After Oesophagectomy in Regional Australia
Scientific title
Textbook Outcomes After Oesophagectomy in a Regional Australian Hospital: a Retrospective Observational Cohort Study
Secondary ID [1] 0 0
2024/STE03324
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophageal Cancer Nos 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
Textbook outcome - Patients that achieve a textbook outcome after oesophagectomy

No textbook outcome - Patients who do not achieve a textbook outcome after oesophagectomy
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Textbook outcome
Timepoint [1] 0 0
from date of surgery to end of study (December 2024) for a timeframe up to 10 years

Eligibility
Key inclusion criteria
* all patients who underwent oesophagectomy between January 2014 and 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
1/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
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

Ethics approval
Ethics application status

Summary
Brief summary
The goal of this observational cohort study is to assess textbook outcomes after oesophagectomy in a regional Australian hospital. This is a composite quality measure that include 9 parameters related to cancer care. Researchers will compares the textbook outcome rate in this regional hospital and compare it to textbook outcomes rates from other Australian hospitals, as well as hospitals overseas. Participants will not be actively involved in this study, as all data will be collected from medical records only.
Trial website
https://clinicaltrials.gov/study/NCT06721715
Trial related presentations / publications
Kalff MC, Vesseur I, Eshuis WJ, Heineman DJ, Daams F, van der Peet DL, van Berge Henegouwen MI, Gisbertz SS. The Association of Textbook Outcome and Long-Term Survival After Esophagectomy for Esophageal Cancer. Ann Thorac Surg. 2021 Oct;112(4):1134-1141. doi: 10.1016/j.athoracsur.2020.09.035. Epub 2020 Nov 19.
Kay B, Healy TE. Propofol ('Diprivan') for outpatient cystoscopy. Efficacy and recovery compared with althesin and methohexitone. Postgrad Med J. 1985;61 Suppl 3:108-14.
Kalff MC, van Berge Henegouwen MI, Gisbertz SS. Textbook outcome for esophageal cancer surgery: an international consensus-based update of a quality measure. Dis Esophagus. 2021 Jul 12;34(7):doab011. doi: 10.1093/dote/doab011.
Ball ED, Keefe KA, Colby E. Expression of antigens associated with small cell carcinoma of the lung on hematopoietic progenitor cells. Cancer Res. 1987 Dec 15;47(24 Pt 1):6556-9.
van der Werf LR, Wijnhoven BPL, Fransen LFC, van Sandick JW, Nieuwenhuijzen GAP, Busweiler LAD, van Hillegersberg R, Wouters MWJM, Luyer MDP, van Berge Henegouwen MI. A National Cohort Study Evaluating the Association Between Short-term Outcomes and Long-term Survival After Esophageal and Gastric Cancer Surgery. Ann Surg. 2019 Nov;270(5):868-876. doi: 10.1097/SLA.0000000000003520.
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 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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06721715