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

July 2, 2014 updated by: Ewen Harrison, University of Edinburgh
A multicentre, international evaluation of emergency abdominal surgery to establish surgical outcomes and identify common, modifiable best practice processes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Recruiting
        • Royal Infirmary of Edinburgh
        • Contact:
        • Sub-Investigator:
          • Stuart J Fergusson, MBChB, MRCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will be recruited from all acute surgical units worldwide which provide an emergency surgery service.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 24 hours following conclusion of the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 30 days from the operation (or point of discharge- see definition)
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.
Up to 30 days from the operation (or point of final discharge - see below)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

June 29, 2014

First Submitted That Met QC Criteria

June 29, 2014

First Posted (Estimate)

July 1, 2014

Study Record Updates

Last Update Posted (Estimate)

July 3, 2014

Last Update Submitted That Met QC Criteria

July 2, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NR/1404AB12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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