An observational study in Oesophageal Cancer Nos, sponsored by Launceston General Hospital. Not yet recruiting at 1 site in Australia. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Launceston General Hospital · Observational
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.
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.
1,631 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 346 observational studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Launceston General Hospital is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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All patients who underwent oesophagectomy at a single regional hospital in Tasmania, Australia between January 2014 and December 2023 will be included in this study,
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Exclusion Criteria:
Patients that achieve a textbook outcome after oesophagectomy
Patients who do not achieve a textbook outcome after oesophagectomy
Textbook outcome
Patients 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).
Time frame: from date of surgery to end of study (December 2024) for a timeframe up to 10 years
Plan to share: No
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Launceston General Hospital