Determining Universal Processes Related to Best Outcome in Emergency Gastrointestinal Surgery: an International Evaluation

Surgical Procedures, Operative Clinical Trial

— GlobalSurg-1  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02179112
• Other study ID #: NR/1404AB12
• Status: Recruiting
• Phase: N/A
• First received: June 29, 2014
• Last updated: July 2, 2014
• Start date: July 2014
• Est. completion date: January 2015

Study information

• Verified date: July 2014
• Source: University of Edinburgh
• Contact: Ewen M Harrison, PhD, FRCS
• Phone: +44 131 242 3616
• Email: ewen.harrison[@]ed.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Centre Inclusion Criteria:

• Any acute surgical unit worldwide is eligible to enter

• All participating centres will be required to register their details, complete an online training module, and complete a pilot audit prior to commencing.

• Centres must ensure that they can include consecutive patients and provide at least 95% data completeness.

• There is no minimum number of patients per centre, as long as the patient(s) included are consecutive.

Inclusion Criteria:

• All sequential patients undergoing emergency intra-peritoneal surgery during the chosen 2-week period should be included.

• Emergency (unplanned, non-elective, same admission) procedures only. This includes patients undergoing an emergency re-operation after a previous procedure on the same in-patient stay.

• Laparoscopic, laparoscopic converted and open cases can be included.

• Any age patient (adult and paediatric) can be included.

Exclusion Criteria:

• Elective (planned) or semi-elective (where patient initially admitted as an emergency, then discharged from hospital, and re-admitted at later time for surgery) procedures.

• Caesarean section. These patients represent a separate operative group, with different priorities and treatment pathways. They have been studied in detailed elsewhere, and their frequency would skew the results of this study.

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Surgical Procedures, Operative

Intervention

Procedure:
• Emergency Abdominal Surgery
Emergency intra-peritoneal surgery (only exclusion: Caesarian section).

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour peri-operative mortality rate	Number of deaths during operation or within 24 hours of operation conclusion, divided by number of operations undertaken.	At 24 hours following conclusion of the operation	Yes
Secondary	30-day peri-operative mortality rate (POMR-30)	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.	Up to 30 days from the operation (or point of discharge- see definition)	Yes
Secondary	30-day peri-operative serious complication rate	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.	Up to 30 days from the operation (or point of final discharge - see below)	Yes

External Links

•   Full protocol - online