Post Oesophagectomy Outcomes in a Single Regional Centre in Australia

November 2, 2024 updated by: Renishka Sellayah, Launceston General Hospital

An Australian Regional Hospital's Oesophagectomy Outcomes

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Renishka N Sellayah, MBBS (hons) FRACS
  • Phone Number: +61 425 816 462
  • Email: r.sellayah@gmail.com

Study Contact Backup

Study Locations

  • Australia
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Launceston General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Girish Pande, FRACS
        • Sub-Investigator:
          • Renishka Sellayah, FRACS
        • Sub-Investigator:
          • Kevin Yoong, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients who underwent oeophagectomy at Launceston General Hospital between January 2014 to December 2023

Description

Inclusion Criteria:

  • patients who underwent oeophagectomy at Launceston General Hospital between January 2014 to December 2023

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
oesophagectomy
patients who underwent oesophagectomy within the specified time frame
Other: No Intervention: Observational Cohort
No intervention - retrospective observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 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
from date of surgery to end of study (November 2024) for a timeframe up to 10 years
Anastomotic leak
Time Frame: 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)
from date of surgery to end of study period (Nov 2024), assessed up to 10 years
Length of stay
Time Frame: 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
from date of surgery to discharge date of hospital admission, approximately 2-4 weeks in most cases but assessed up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Launceston General Hospital

Collaborators

Department of Health, Tasmania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

November 14, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 2, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024/ETH01712

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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