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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
Sponsor:
Information provided by (Responsible Party):
Ewen Harrison, University of Edinburgh

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

Condition or disease Intervention/treatment
Surgical Procedures, Operative Procedure: Emergency Abdominal Surgery

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 [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Study Start Date : July 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : January 2015

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


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population will be recruited from all acute surgical units worldwide which provide an emergency surgery service.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Ewen M Harrison, PhD, FRCS +44 131 242 3616 ewen.harrison@ed.ac.uk
Contact: Stuart J Fergusson, BSc, MRCS sjfergusson@doctors.org.uk

Locations
United Kingdom
Royal Infirmary of Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SA
Contact: Stuart J Fergusson, MBChB, MRCS       stuart.fergusson@ed.ac.uk   
Sub-Investigator: Stuart J Fergusson, MBChB, MRCS         
Sponsors and Collaborators
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ewen Harrison, Senior Lecturer and Honorary Consultant Surgeon, University of Edinburgh
ClinicalTrials.gov Identifier: NCT02179112     History of Changes
Other Study ID Numbers: NR/1404AB12
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: July 2014

Keywords provided by Ewen Harrison, University of Edinburgh:
Surgery
Specialties, Surgical
Geography, Medical
Developing Countries
Developed Countries
Laparotomy
Outcome and Process Assessment (Health Care)
Treatment Outcome
Quality of Health Care