The hold study – tugs multinational audit – stomach cancer elective surgery morbidity and mortality at 90-day

Overview

Project Summary

Gastric neoplasia is the fourth most common neoplasm in all age groups in both sexes and is the third leading cause of mortality from neoplasia in the world, according to 2018 data from the World Health Organisation (WHO). Surgical resection with regional lymphadenectomy remains the standard treatment.

Despite the significant improvement in the treatment of gastric neoplasia, its surgical treatment is still considered high-risk and shows great differences in results between different countries, the reasons for which are unclear. Centralisation of treatment and the use of multimodal approaches have been proposed as strategies to improve results. In addition, laparoscopic and robotic approaches are increasingly being used, with better results in short-term safety and comparable long-term oncological outcomes when compared to open gastrectomy.

Several studies suggest that post-operative outcomes differ significantly between Asian and Western centres, with 30-day mortality rates of around 1% and 5% respectively. Although mortality is easier to quantify, the reporting of morbidity rates has suffered from the lack of a standardised system, with reported morbidity rates ranging from 10% to 40%.

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 "GASTRODATA International standardised system for postoperative (General and Surgical)", and the degree of complications, including mortality, will be assessed using the Clavien-Dindo Classification.

3. The collaborators will obtain local approval to enter the morbidity and mortality data for the 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 promoter (see annex). 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: assessing mortality and morbidity in patients undergoing elective surgery for gastric neoplasia

"Secondary end point: determining factors associated with mortality and morbidity at 90 days in patients undergoing elective surgery for gastric neoplasia

Project Details