Abdominal TraumaGOAL-TraumaNCT06180668
Global Outcomes After Laparotomy for Trauma
An observational study of Abdominal Trauma, run by University of Cambridge.
Trial summary
The goal of this observational study is to assessing the global variation in patient characteristics, management, and outcomes in those undergoing trauma laparotomy. 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Trauma
- What is being tested?
- Trauma Laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 552 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Feb 2025
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing a trauma laparotomy for either a blunt or penetrating injury within 5 days of presenting to the treating centre.
Who may be able to join
- Any patients of any ages who presents to hospital with a blunt or penetrating injury and undergo a trauma laparotomy within 5 days of presentation to the treating centre
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Tom Bashford, PhD contact
About this study
Official title: Global Outcomes After Laparotomy for Trauma: The GOAL-Trauma Study
The goal of this observational study is to assessing the global variation in patient characteristics, management, and outcomes in those undergoing trauma laparotomy.
The main questions it aims to answer are:
Read more
- 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.
Read the detailed description
We will conduct a prospective multi-centre observational cohort study of patients undergoing a trauma laparotomy. We will recruit centres through pre-existing research networks, utilising a snowballing technique to expand registration of centres. We will enrol eligible patients undergoing emergency trauma laparotomy over a consecutive 30 day period at individual centres during the study dates, with patients followed until discharge, death, or 30 days post-operatively, whichever comes first. All data will be submitted to a central study team by 30 days after the end of their respective data study period.
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
- Abdominal Trauma
- Being tested
- Trauma Laparotomy
- Medical subject headings
- Abdominal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma LaparotomyProcedure or surgery
Emergency abdominal surgery through midline incision to access abdominal and / or pelvic organs, to access identified injuries or exploratory diagnostic reasons
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Trauma Laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All cause 30-day post-operative mortality rate
Measured: 30 days post-operatively
Secondary outcomes (3)
Length of Hospital Stay
Time in hospital, from the operation until discharge
Measured: 30 days post-operatively
Morbidity Rates
Any post-operative morbidity that occurred to the patient, as defined by the adapted Clavien-Dindo in trauma scale
Measured: 30 days post-operatively
Discharge Destination
At time of discharge or stepdown from hospital, location the patient was discharged
Measured: 30 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study startApr 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abdominal TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Bath, University of Cambridge
- Investigators
- Tom Bashford, PhD, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180668
- Sponsor's protocol ID
- GlobalTraumaLaprotomy
- Acronym
- GOAL-Trauma
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aziz R, Bath MF, Abdelmohsen SM, Chukwu I, Saleh R, Caceres E, Nuno-Guzman CM, Amoako J, Nagraj S, Karusoke DK, Hobbs L, Smith BG, Kohler K, Hardcastle TC, Perkins ZB, Weiser TG, Lakhoo K, Bashford T; GOAL-Trauma Collaborative. Global variation in injury patterns, interventions, and post-operative outcomes for children and adolescents undergoing trauma laparotomy: an international cohort study. Lancet Child Adolesc Health. 2026 Jul;10(7):505-514. doi: 10.1016/S2352-4642(26)00069-6. Epub 2026 May 7.
PubMed 42107384Ng WH, Bath MF, Amoako J, Kohler K, Baderhabusha DU, Caceres E, Nuno-Guzman CM, Moonesinghe R, Hobbs L, Smith BG, Weiser TG, Hardcastle TC, Perkins ZB, Bashford T; GOAL-Trauma Collaborative. Use of pre-operative blood products in abdominal trauma: a planned secondary analysis of the GOAL-trauma study. EClinicalMedicine. 2026 Mar 4;93:103814. doi: 10.1016/j.eclinm.2026.103814. eCollection 2026 Mar.
PubMed 41938841Bath 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.
PubMed 40972623
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Outcomes After Laparotomy for Trauma: The GOAL-Trauma Study
- ClinicalTrials.gov ID
- NCT06180668
- Acronym / sponsor ID
- GOAL-Trauma / GlobalTraumaLaprotomy
- Conditions
- Abdominal Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to assessing the global variation in patient characteristics, management, and outcomes in those undergoing trauma laparotomy.
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
We will conduct a prospective multi-centre observational cohort study of patients undergoing a trauma laparotomy. We will recruit centres through pre-existing research networks, utilising a snowballing technique to expand registration of centres. We will enrol eligible patients undergoing emergency trauma laparotomy over a consecutive 30 day period at individual centres during the study dates, with patients followed until discharge, death, or 30 days post-operatively, whichever comes first. All data will be submitted to a central study team by 30 days after the end of their respective data study period.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma Laparotomy Patients | – | Procedure: Trauma LaparotomyPatients 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing a trauma laparotomy for either a blunt or penetrating injury within 5 days of presenting to the treating centre.
Key inclusion criteria (1 listed)
- Any patients of any ages who presents to hospital with a blunt or penetrating injury and undergo a trauma laparotomy within 5 days of presentation to the treating centre
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma LaparotomyEmergency abdominal surgery through midline incision to access abdominal and / or pelvic organs, to access identified injuries or exploratory diagnostic reasons | Procedure or surgery | Trauma Laparotomy Patients |
Primary outcome
Mortality
Time frame: 30 days post-operatively
All cause 30-day post-operative mortality rate
3 secondary outcomes
Length of Hospital Stay
Time frame: 30 days post-operatively
Morbidity Rates
Time frame: 30 days post-operatively
Discharge Destination
Time frame: 30 days post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Derived from this study: PubMed 42107384Aziz R, Bath MF, Abdelmohsen SM, Chukwu I, Saleh R, Caceres E, Nuno-Guzman CM, Amoako J, Nagraj S, Karusoke DK, Hobbs L, Smith BG, Kohler K, Hardcastle TC, Perkins ZB, Weiser TG, Lakhoo K, Bashford T; GOAL-Trauma Collaborative. Global variation in injury patterns, interventions, and post-operative outcomes for children and adolescents undergoing trauma laparotomy: an international cohort study. Lancet Child Adolesc Health. 2026 Jul;10(7):505-514. doi: 10.1016/S2352-4642(26)00069-6. Epub 2026 May 7.
- Derived from this study: PubMed 41938841Ng WH, Bath MF, Amoako J, Kohler K, Baderhabusha DU, Caceres E, Nuno-Guzman CM, Moonesinghe R, Hobbs L, Smith BG, Weiser TG, Hardcastle TC, Perkins ZB, Bashford T; GOAL-Trauma Collaborative. Use of pre-operative blood products in abdominal trauma: a planned secondary analysis of the GOAL-trauma study. EClinicalMedicine. 2026 Mar 4;93:103814. doi: 10.1016/j.eclinm.2026.103814. eCollection 2026 Mar.
- Derived from this study: PubMed 40972623Bath 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.
- Main Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Bashford, PhD contact
Tom Bashford, PhD principal investigator
University of Cambridge
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Trauma, run by University of Cambridge.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael F Bath, MBChB (+44 (0)1223748577, mb2583@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days post-operatively). 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 NCT06180668, which also lists 3 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 Dec 2023.