Surgical Procedures, Operative Clinical Trial
A multicentre, international evaluation of emergency abdominal surgery to establish surgical outcomes and identify common, modifiable best practice processes.
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.
;
Observational Model: Ecologic or Community, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03731039 -
Postoperative Pain in Adult Patients.
|
||
Recruiting |
NCT04010058 -
Postoperative Continuous Non-invasive Haemodynamic Monitoring on the Ward
|
N/A | |
Completed |
NCT03805230 -
Postoperative Vasopressor Usage: SQUEEZE
|
||
Completed |
NCT03694899 -
The Excess Opioid Disposal Study
|
N/A | |
Completed |
NCT03330236 -
EEG - Guided Anesthetic Care and Postoperative Delirium
|
N/A | |
Completed |
NCT04097054 -
The 3P Trial: Preoperative Planning and Preparation of Complex and Rare Procedures in GI Surgery
|
N/A | |
Recruiting |
NCT05736822 -
The Impact of the COVID-19 Pandemic on the Patient in Need of an Intervention
|
||
Recruiting |
NCT05703230 -
Effects of Preoperative Multidisciplinary Team Meetings for High-risk, Adult, Noncardiac Surgical Patients
|
N/A | |
Completed |
NCT02353182 -
The T REX Pilot Study: a Study to Investigate the Use of an Alternative Anaesthetic in Infants.
|
Phase 4 | |
Completed |
NCT02809937 -
Dexmedetomidine and Long-term Outcome in Elderly Patients After Surgery
|
Phase 4 | |
Completed |
NCT02599233 -
Characterization of Post-operative Pain Trajectories Over Seven Days and Links With Chronicity
|
N/A | |
Completed |
NCT00816023 -
A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
|
Phase 2 | |
Not yet recruiting |
NCT04744688 -
Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment
|
||
Completed |
NCT01865513 -
POPULAR: POst-operative PULmonary Complications After Use of Muscle Relaxants in Europe
|
N/A | |
Completed |
NCT00888940 -
Outcomes and Safety Trial Investigating Ecallantide's Effect on Reducing Surgical Blood Loss Volume in Subjects at High Risk of Bleeding Exposed to Cardio-pulmonary Bypass During Cardiac Surgery
|
Phase 2 | |
Completed |
NCT00918437 -
Postoperative Pain Course After Uvulopalatoplasty
|
N/A | |
Completed |
NCT02189642 -
Boston Children's Hospital Post Anesthesia Care Unit Outcomes Study
|
N/A | |
Not yet recruiting |
NCT06338163 -
Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery
|
Phase 4 | |
Recruiting |
NCT05211375 -
Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial
|
Phase 3 | |
Completed |
NCT01929928 -
Evaluation of Efficacy and Accuracy of a Cordless Ultrasonic Dissection System
|