Determining Universal Processes Related to Best Outcome in Emergency Gastrointestinal Surgery: an International Evaluation (GlobalSurg-1)
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|ClinicalTrials.gov Identifier: NCT02179112|
Recruitment Status : Unknown
Verified July 2014 by Ewen Harrison, University of Edinburgh.
Recruitment status was: Recruiting
First Posted : July 1, 2014
Last Update Posted : July 3, 2014
|Condition or disease||Intervention/treatment|
|Surgical Procedures, Operative||Procedure: Emergency Abdominal Surgery|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2500 participants|
|Observational Model:||Ecologic or Community|
|Target Follow-Up Duration:||30 Days|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||January 2015|
- Procedure: Emergency Abdominal Surgery
Emergency intra-peritoneal surgery (only exclusion: Caesarian section).
- 24-hour peri-operative mortality rate [ Time Frame: At 24 hours following conclusion of the operation ]Number of deaths during operation or within 24 hours of operation conclusion, divided by number of operations undertaken.
- 30-day peri-operative mortality rate (POMR-30) [ Time Frame: Up to 30 days from the operation (or point of discharge- see definition) ]
Number of deaths during operation or within 30 days of operation, or at the point of final discharge if out-patient mortality status unknown.
Please see reference for justification of our use of this definition in our global cohort.
- - -
Watters DA, Hollands MJ, Gruen RL, Maoate K, Perndt H, McDougall RJ, et al. Perioperative Mortality Rate (POMR): A Global Indicator of Access to Safe Surgery and Anaesthesia. World J Surg. 2014 May 20;1-9.
- 30-day peri-operative serious complication rate [ Time Frame: Up to 30 days from the operation (or point of final discharge - see below) ]
Number of serious complications occurring, divided by number of operations. Measured at operation or within 30 days of operation, or point of final discharge if out-patient information unavailable. (See definition of POMR-30 above for justification).
Serious complications defined as Grade III or V within the Clavien-Dindo classification (Grade III = complications requiring surgical, endoscopic or radiological intervention; Grade V = death).
- - -
Dindo D, Demartines N, Clavien P-A. Classification of Surgical Complications. Ann Surg. 2004 Aug;240(2):205-13.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179112
|Contact: Ewen M Harrison, PhD, FRCS||+44 131 242 firstname.lastname@example.org|
|Contact: Stuart J Fergusson, BSc, MRCSemail@example.com|
|Royal Infirmary of Edinburgh||Recruiting|
|Edinburgh, United Kingdom, EH16 4SA|
|Contact: Stuart J Fergusson, MBChB, MRCS firstname.lastname@example.org|
|Sub-Investigator: Stuart J Fergusson, MBChB, MRCS|
|Principal Investigator:||Ewen M Harrison, PhD, FRCS||University of Edinburgh|
|Study Director:||Aneel Bhangu, MBChB, MRCS||University of Birmingham|
|Study Director:||J E Fitzgerald, BA, MRCS||Lifebox Foundation|
|Study Director:||Stuart J Fergusson, BSc, MRCS||University of Edinburgh|