Skip to content

Textbook Outcomes After Oesophagectomy in Regional Australia

Textbook Outcomes After Oesophagectomy in a Regional Australian Hospital: a Retrospective Observational Cohort Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06721715
Enrollment
100
Registered
2024-12-06
Start date
2024-12-31
Completion date
2024-12-31
Last updated
2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oesophageal Cancer Nos

Keywords

oesophagectomy, oesophageal cancer, regional surgery

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.

Detailed description

Rationale Textbook outcomes is a composite tool to assess the quality of cancer care within an institution by evaluating several perioperative and postoperative factors. Most studies assessing textbook outcomes after oesophagectomy have been conducted in high-volume centres, achieving rates of up to 50%. To the best of our knowledge this is the first study to assess textbook outcomes after oesophagectomy in a regional Australian hospital, providing a unique insight into the performance of this procedure in a country that has not widely adopted centralisation of cases. Aims/objectives To calculate textbook outcomes rates in a regional hospital in Australia and compare to higher volume Australian and international institutions. Methods Retrospective identification of patients from MBS codes related to oesphagectomy, and collection of data retrospectively from the medical record only. All patients undergoing oesophagectomy from January 2014 to December 2023 will be included. There are no exclusion criteria. Data collection Baseline patient characteristics, tumour-specific factors, textbook outcome parameters, treatment details including postoperative complications, and follow up data on survival will be collected Statistical analysis Statistical analysis will be performed in consultation with a biostatistician. The number and proportion of patients who meet each parameter of the textbook outcome will be calculated for each year and compared. Patient characteristics (age, gender, BMI and ASA grade), tumour factors (histology, AJCC clinical T and N stage), and treatment aspects (neoadjuvant therapy and surgical approach) will be assessed for association with textbook outcomes using the Chi squared test with significance considered less than 0.05. A Kaplan-Meier survival curve will be used to investigate overall survival of patients with and without a textbook outcome.

Interventions

None listed

Sponsors

Launceston General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* all patients who underwent oesophagectomy between January 2014 and December 2023

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Textbook outcomefrom date of surgery to end of study (December 2024) for a timeframe up to 10 yearsPatients who achieve a textbook outcome. This is defined when all 9 following criteria are met: R0 resection, retrieval of 15 or more lymph nodes, no intraoperative complications, no post-operative complications Clavien-Dindo grade III or higher, no readmission to the ICU, no hospital stay longer than 21 days, no mortality within 90 days, no readmission related to the procedure within 30 days of admission, and no reintervention related to the surgical procedure (operative, endoscopic or radiologic).

Countries

Australia

Contacts

Primary ContactRenishka Sellayah, MBBS (hons) FRACS
r.sellayah@gmail.com+61 425 816 462
Backup ContactGirish Pande, FRACS
girish.pande@ths.tas.gov.au+61 439 656 110

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026