The outlive study - oesophageal and junctional cancer elective surgery morbidity and mortality at 90-day: a tugs multinational audit

Overview

Project Summary

Neoplasms of the oesophago-gastric transition and oesophagus are globally the seventh most common neoplasm in terms of incidence and the sixth most common in terms of cancer mortality. These tumours are a major global health problem, especially in countries with weaker economies. Oesophagectomy is potentially curative, but it remains a technically complex operation associated with high post-operative morbidity and mortality, especially with a transthoracic approach. The role of the minimally invasive approach to the thoracic and abdominal cavities is increasing in clinical practice, with lower rates of post-operative complications, especially pulmonary complications. There is also significant variation in results between different countries.

Hospital morbidity and mortality at 90 days seem to more accurately reflect the real incidence of events associated with oesophagectomy than the results at 30 days. European and North American data suggest a hospital mortality of 8 per cent and a 90-day mortality of approximately 13 per cent. There has also been evidence to support the centralisation of oesophageal surgical treatment in high-volume centres, with lower perioperative mortality in these centres.

Meta-analyses carried out previously have shown considerable heterogeneity in methodology, which has made it impossible to generate a truly representative picture of the short-term results associated with oesophagectomy. This led to an attempt to standardise the reporting of outcomes relating to mortality, complications and quality measures after oesophageal surgery, instituted by the Esophagectomy Complications Consensus Group (ECCG) in 2011.

There is currently a need for a global understanding of early post-operative morbidity and mortality after elective oesophagectomy for oesophageal neoplasia in order to guide projects to improve the quality of hospital care.

1 This is a quality assessment carried out by a multinational audit. The audit will not influence clinical practice in any way.

2. Morbidity will be classified on the basis of the international standardised system "ESODATA", and the degree of complications, including mortality, will be assessed using the Clavien-Dindo Classification.

3. Collaborators will obtain local approval to enter morbidity and mortality data on patients treated.

4. Staff will inform patients that their morbidity and mortality data will be entered into the audit database and that the data will be stored in the UK.

5. Employees must ensure that all their patients are entered consecutively during the study period. Entering only a few patients will lead to selection bias.

6. Patient data will only be considered complete if data is collected 90 days post-operatively.

7. Data will be grouped before analysis to further protect the anonymity of individual patients.

8. The data will be sent to an email established by the promoter in a Microsoft Excel ® file and protected by a password.

9. The data collection file template to be used is provided by the sponsor (see appendix). All data must be entered using the same template to facilitate collation and analysis and to avoid errors.

10. Only data in the standardised MS Excel file format will be accepted, strictly following the rules defined. The data cannot be altered afterwards.

11. The deadline for sending all data is 15 January 2023.

12. The duration of the audit may be extended depending on the number of patients recruited.

 Statistical study:

1. Standard descriptive statistical methods will be used.

2. Sample size calculation is not necessary for an audit of this nature.

Main Goals

"Primary end point: 90-day mortality and morbidity in patients undergoing elective surgery for oesophageal neoplasia and oesophago-gastric transition

"Secondary end point: to determine factors associated with 90-day mortality and morbidity in patients undergoing elective surgery for oesophageal neoplasia and oesophago-gastric transition.

Project Details