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Surgical Procedures, OperativeGlobalSurg-1NCT02179112

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

An observational study of Surgical Procedures, Operative, run by University of Edinburgh at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Surgical Procedures, Operative
What is being tested?
Emergency Abdominal Surgery
Type of treatment
Surgery or procedure
How many people
10,745 participants
Where
1 siteUnited Kingdom
Study dates
Jul 2014to Jun 2017
How long will I take part?
30 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA

Other trials in United Kingdom

About this study

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

Read the 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.

Being tested
Emergency Abdominal Surgery
Keywords
Surgery, Specialties, Surgical, Geography, Medical, Developing Countries, Developed Countries, Laparotomy, Outcome and Process Assessment (Health Care), Treatment Outcome, Quality of Health Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emergency Abdominal SurgeryProcedure or surgery

    Emergency intra-peritoneal surgery (only exclusion: Caesarian section).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 24-hour peri-operative mortality rate

    Number of deaths during operation or within 24 hours of operation conclusion, divided by number of operations undertaken.

    Measured: At 24 hours following conclusion of the operation

Secondary outcomes (2)

  1. 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.

    Measured: Up to 30 days from the operation (or point of discharge- see definition)

  2. 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.

    Measured: Up to 30 days from the operation (or point of final discharge - see below)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionJun 2017
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
10,745 participants (actual)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT02179112
Sponsor's protocol ID
NR/1404AB12
Acronym
GlobalSurg-1
Status last verified
Jun 2021
First submitted
29 Jun 2014
Last updated
22 May 2024
Results posted
No
Data monitoring committee
No

Publications

  • GlobalSurg Collaborative. Laparoscopy in management of appendicitis in high-, middle-, and low-income countries: a multicenter, prospective, cohort study. Surg Endosc. 2018 Aug;32(8):3450-3466. doi: 10.1007/s00464-018-6064-9. Epub 2018 Apr 5.

    PubMed 29623470

  • GlobalSurg Collaborative. Determinants of morbidity and mortality following emergency abdominal surgery in children in low-income and middle-income countries. BMJ Glob Health. 2016 Dec 12;1(4):e000091. doi: 10.1136/bmjgh-2016-000091. eCollection 2016.

    PubMed 28588977

  • GlobalSurg Collaborative. Mortality of emergency abdominal surgery in high-, middle- and low-income countries. Br J Surg. 2016 Jul;103(8):971-988. doi: 10.1002/bjs.10151. Epub 2016 May 4.

    PubMed 27145169

  • Bhangu A, Fitzgerald JE, Fergusson S, Khatri C, Holmer H, Soreide K, Harrison EM. Determining universal processes related to best outcome in emergency abdominal surgery: a multicentre, international, prospective cohort study. BMJ Open. 2014 Oct 29;4(10):e006239. doi: 10.1136/bmjopen-2014-006239.

    PubMed 25354824

Questions about this trial

What is this clinical trial studying?

An observational study of Surgical Procedures, Operative, run by University of Edinburgh at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour peri-operative mortality rate (time frame: At 24 hours following conclusion of the operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02179112, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.

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