Global Outcomes After Laparotomy for Trauma

NCT06180668 | Unknown

• 1 other identifier: GlobalTraumaLaprotomy
• Study Type: observational
• Target: 552
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Abdominal Trauma

Outcome Measures

Primary Outcomes (1)

• Mortality

  All cause 30-day post-operative mortality rate

  30 days post-operatively

Secondary Outcomes (3)

• Length of Hospital Stay

  30 days post-operatively

• Morbidity Rates

  30 days post-operatively

• Discharge Destination

  30 days post-operatively

Study Arms (1)

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

Procedure: Trauma Laparotomy

Interventions

Trauma Laparotomy PROCEDURE

Emergency abdominal surgery through midline incision to access abdominal and / or pelvic organs, to access identified injuries or exploratory diagnostic reasons

Trauma Laparotomy Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a trauma laparotomy for either a blunt or penetrating injury within 5 days of presenting to the treating centre.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cambridge: lead

Related Publications (1)

• 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.

  PMID: 40972623 DERIVED

Related Links

• Main Study Website

MeSH Terms

Conditions

Abdominal Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Tom Bashford, PhD

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael F Bath, MBChB

CONTACT

+44 (0)1223748577; mb2583@cam.ac.uk

Tom Bashford, PhD

CONTACT

tb508@cam.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Student

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: December 22, 2023

Record last verified: 2023-12