Post Oesophagectomy Outcomes in a Single Regional Centre in Australia
- Conditions
- Oesophageal Cancer
- Registration Number
- NCT06662513
- Lead Sponsor
- Launceston General Hospital
- Brief Summary
Literature review/rationale for project
* Oesophageal cancer is associated with a grim prognosis despite many advances in treatment. Oesophagectomy is a key component of the care of patients who are candidates for curative treatment, however it is associated with substantial morbidity.
* Several studies have suggested that oesophagectomies performed at higher volume tertiary centres are associated with lower morbidity and mortality than lower volume centres, and this has prompted changes to policy in countries such as Great Britain, Canada and the Netherlands with regards to the centralisation of these cases. A higher volume centre within Australia is likely to perform 6 or more procedures per year.
* Currently within Australia, centralisation on a large scale has not occurred. This has been limited in part by resource provision and geographical barriers. Therefore, oesophagectomies in Australia are still routinely performed in regional centres. However, there is a paucity of recent outcomes data from these centres.
Aims/objectives
* Retrospective review of oesophagectomies undertaken in a single regional centre in Tasmania, Australia over 10 years (January 2014 to December 2023)
* Assess outcomes (long and short-term complications and mortality) and compare to morbidity and mortality rates from larger international centres
- Detailed Description
Research aims/objectives
* Retrospective review of oesophagectomies undertaken in a single regional centre in Tasmania, Australia over 10 years (January 2014 to December 2023)
* Assess outcomes (long and short-term complications, mortality, survival) and compare to published outcomes from larger national and international centres
Project Design Research project setting: Launceston General Hospital (Tasmania, Australia)
Methodological approach: Retrospective case series
Participants
* Retrospective identification of patients who underwent oesophagectomy at Launceston General Hospital from January 2014 to December 2023 via coding in medical records and MBS codes
* Inclusion criteria: patients who underwent oeosphagectomy at LGH in the specified time frame
* Exclusion criteria: none
* Expected size of case series is approximately 100 patients (this is extrapolated from the number of oesophagectomies performed in 2023)
Participant recruitment strategies and timeframes: No active participation of patients in this case series, all information will be retrospectively collected from medical records
Consent: Given the number of expected patients (approximately 100) and the potential distress that could be caused to patients or their next of kin in seeking consent, an Application for the Waiver of the requirement for Consent will be submitted
Research Activities
* No participant commitment is required
* Project duration is approximately 4 weeks for data collection, 4 weeks for analysis and writing
* No Participant follow-up is planned as part of this project
Data Collection/Gathering
* Data will be collected by assessment medical records only
* Only the PI will access identifying details such as name and date of birth.
* Information that will be collected includes: Patient demographics: age, gender, neoadjuvant treatment, co-morbidities, BMI, ASA score, type of oesophagectomy (2 or 3 stage). Primary endpoints: mortality (in hospital, 30 day and 90 day), anastomotic leak, length of stay (ICU, acute inpatient). Secondary endpoints: chyle leak, pneumonia, reintubation, return to theatre, wound infection, intra-abdominal infection, cardiac complications, DVT/PE, anastomotic stricture, diaphragmatic hernia, disease recurrence, survival
Data Management
* Data will be entered into an excel spreadsheet kept on a password protected THS computer in the department of surgery in LGH
* Data will only be accessed by the named investigators that are based at LGH (no external researcher will have access to data)
* There will be no hard copies of this data
* Data will not be transferred to personal computers/laptops
* Data will be destroyed/deleted by the PI 5 years after publication date
Data Analysis
* Outcomes will be calculated as percentages and then compared to published outcomes data from other Australian centres and international centres Examples of some published studies that may be used to compare outcomes are listed in citations.
* Given the retrospective nature of the data collection it is anticipated that some information will be missing however the kind of data the investigators plan to collect is very likely to be found in the medical record.
* Any missing information will be acknowledged when assessing results and the impact of the missing information will also be acknowledged when making any conclusions from those results
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- patients who underwent oeophagectomy at Launceston General Hospital between January 2014 to December 2023
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mortality from date of surgery to end of study (November 2024) for a timeframe up to 10 years date of death from any cause or date of palliation whichever came first
Anastomotic leak from date of surgery to end of study period (Nov 2024), assessed up to 10 years Grade 1-3, diagnosed radiologicaly, requiring intervention (surgical or non-surgical)
Length of stay from date of surgery to discharge date of hospital admission, approximately 2-4 weeks in most cases but assessed up to 12 weeks total inpatient hospital stay and total ICU length stay
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Launceston General Hospital
🇦🇺Launceston, Tasmania, Australia