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

NCT02179112 | Completed

• 1 other identifier: NR/1404AB12
• Study Type: observational
• Target: 10,745
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Surgical Procedures, Operative

Keywords

Surgery; Specialties, Surgical; Geography, Medical; Developing Countries; Developed Countries; Laparotomy; Outcome and Process Assessment (Health Care); Treatment Outcome; Quality of Health Care

Outcome Measures

Primary Outcomes (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.

  At 24 hours following conclusion of the operation

Secondary Outcomes (2)

• 30-day peri-operative mortality rate (POMR-30)

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

• 30-day peri-operative serious complication rate

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

Interventions

Emergency Abdominal Surgery PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 29623470 RESULT

• 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.

  PMID: 28588977 DERIVED

• 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.

  PMID: 27145169 DERIVED

• 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.

  PMID: 25354824 DERIVED

Related Links

• Full protocol - online

Study Officials

• Ewen M Harrison, PhD, FRCS

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2014
• First Posted: July 1, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 22, 2024

Record last verified: 2021-06

Locations

GB (1)