Determining Universal Processes Related to Best Outcome in Emergency Gastrointestinal Surgery: an International Evaluation — GlobalSurg-1  

Surgical Procedures, Operative Clinical Trial

Status Recruiting

Clinical Trial Summary

A multicentre, international evaluation of emergency abdominal surgery to establish surgical outcomes and identify common, modifiable best practice processes.

Clinical Trial Description

Background: With over 200 million surgical operations per year worldwide and with nearly every acute hospital providing surgical services, outcomes from emergency general surgery represent internationally important healthcare markers. Best practice and modifiable processes that are relevant to good patient outcomes around the world require validation using patient-level data.

Aim: The primary aim of this study is to identify internationally relevant, modifiable surgical practices (in terms of modifiable equipment and clinical management) associated with best care. These factors will include use of imaging, supplementary oxygen, pulse oximetry, critical care, and safety checklists.

Method: This is a multicentre, international, prospective cohort study. Any hospital in the world performing acute surgery will be eligible to enter. Any patient undergoing emergency surgery with an incision entering the peritoneal cavity is eligible. Routine, anonymised clinical data on consecutive patients will be collected over a two week period in each surgical centre, with up to 30 days follow-up data collected. The primary outcome is 24-hour post-operative mortality rate. Secondary outcomes include 30-day inpatient post-operative mortality rate, and 30-day serious complication rate. Participating centres will also be asked to complete a survey that will collect data on hospital structural and resource characteristics.

Data will be entered and stored securely via the University of Edinburgh's REDCap system. This pragmatic protocol (which will delivered across many low-resource settings) does not allow for independent verification of data entry. Data collection norms are laid out in the protocol, where data definitions are also clearly provided. Sample size is not relevant to this exploratory audit. Centres will only be included where there is at least 95% data completeness.

Potential explanatory variables that will be explored in subsequent analysis include country Human Developmental Index, and resource differences. ;

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Surgical Procedures, Operative

• NCT number: NCT02179112
• Study type: Observational [Patient Registry]
• Source: University of Edinburgh
• Contact: Ewen M Harrison, PhD, FRCS
• Phone: +44 131 242 3616
• Email: ewen.harrison@ed.ac.uk
• Status: Recruiting
• Phase: N/A
• Start date: July 2014
• Completion date: January 2015