Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
552 participants
OBSERVATIONAL
2024-04-30
2025-02-28
Brief Summary
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The main questions it aims to answer are:
* What are the post-operative mortality rates for patients undergoing a trauma laparotomy globally
* What are the epidemiological characteristics (demographics, injury characteristics, baseline clinical characteristics, and surgical case mix) for patients undergoing a trauma laparotomy
* What are the pre-operative, peri-operative, and post-operative processes of care for patients undergoing a trauma laparotomy
This is a purely observational study on patients undergoing trauma laparotomy, with no direct change to clinical care.
Detailed Description
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Any hospital worldwide that performs emergency trauma surgery will be eligible to participate, including both trauma centres and trauma units; a minimum of 1 case must be submitted by the centre during the 30 day study period to be eligible. Each centre's team will be comprised of a local study lead, with maximum 3 members of the local study team for each data collection period. Independent data validators will be also required for select centres.
We will include patients of all ages who present to hospital with a blunt or penetrating injury and undergo a trauma laparotomy within 5 days of presentation to the treating centre (day 0 being time of presentation). A patient will be included for final analysis if \>70% of the data points required have been recorded.
Exclusion criteria are:
* Patients undergoing a laparotomy ≥ 5 days (i.e. 120 hours) since presentation to the treating centre
* Any relook laparotomy, including transfers from another centre for further and / or definitive surgery
* Any laparoscopic (including laparoscopic converted to open), robotic, or image-guided procedures
* Patients who have been recently discharged from any hospital (including for non-trauma related admissions) and have represented within 30 days of discharge
We aim to collect system, patient, process, and outcome data. A data set will be collected on all patients undergoing a trauma laparotomy within the inclusion period. The included data fields were based on work by similar studies and refined through iterative consultation with a global interdisciplinary consortium of clinicians involved in trauma care.
Data will be collected through access to patient records only at each centre, performed by members of the local study team. The patient will not be contacted directly in any capacity during their inpatient stay or after the study and no direct involvement in patient care will occur. Data will be collected directly onto a well-established secure web-based system, REDCap cloud (or recorded temporarily onto a hard copy Data Collection Form and uploaded to REDCap at a later date)
The data collected will include a pragmatic set of variables that allow the proposed research to be conducted, but minimise both risk of identification and exclude extraneous possibly sensitive medical information. Local requisite ethics and approvals will be applied for and be in place before any data collection occurs.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Trauma Laparotomy Patients
Patients of all ages who present to hospital with a blunt or penetrating injury and undergo a trauma laparotomy within 5 days of presentation to the treating centre
Trauma Laparotomy
Emergency abdominal surgery through midline incision to access abdominal and / or pelvic organs, to access identified injuries or exploratory diagnostic reasons
Interventions
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Trauma Laparotomy
Emergency abdominal surgery through midline incision to access abdominal and / or pelvic organs, to access identified injuries or exploratory diagnostic reasons
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any relook laparotomy, including transfers from another centre for further and / or definitive surgery
* Any laparoscopic (including laparoscopic converted to open), robotic, or image-guided procedures
* Patients who have been recently discharged from any hospital (including for non-trauma related admissions) and have represented within 30 days of discharge
ALL
No
Sponsors
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University of Cambridge
OTHER
Responsible Party
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Michael Bath
Research Student
Principal Investigators
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Tom Bashford, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge
Central Contacts
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References
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Bath MF, Amoako J, Kohler K, Hashi AS, Zhang Z, Baderhabusha DU, Caceres E, Nuno-Guzman CM, Marsden M, Carenzo L, Khajanchi M, Saleh R, Edmiston T, Hammer C, Hobbs L, Smith BG, Hutchinson P, Weiser TG, Perkins ZB, Hardcastle TC, Bashford T; GOAL-Trauma Collaborative. Global variation in patient factors, interventions, and postoperative outcomes for those undergoing trauma laparotomy: an international, prospective, observational cohort study. Lancet Glob Health. 2025 Nov;13(11):e1837-e1848. doi: 10.1016/S2214-109X(25)00303-1. Epub 2025 Sep 16.
Related Links
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Main Study Website
Other Identifiers
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GlobalTraumaLaprotomy
Identifier Type: -
Identifier Source: org_study_id