Textbook Outcomes After Oesophagectomy in Regional Australia

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Oesophageal Cancer Nos

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Girish Pande, FRACS; Phone Number: +61 439 656 110; Email: girish.pande@ths.tas.gov.au
• Study Contact Backup: Name: Renishka Sellayah, MBBS (hons) FRACS; Phone Number: +61 425 816 462; Email: r.sellayah@gmail.com

Study Locations

• Australia
  • Tasmania
    • Launceston, Tasmania, Australia, 7250
      • Launceston General Hospital
      • Contact: Girish Pande, FRACS; Phone Number: +61 439 656 110; Email: girish.pande@ths.tas.gov.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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,

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Textbook outcome; Patients that achieve a textbook outcome after oesophagectomy
No textbook outcome; Patients who do not achieve a textbook outcome after oesophagectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	from date of surgery to end of study (December 2024) for a timeframe up to 10 years

Collaborators and Investigators

• Sponsor: Launceston General Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Estimated): December 6, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: oesophageal cancer; oesophagectomy; regional surgery
• Other Study ID Numbers: 2024/STE03324

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