Clinical Outcomes of Non-Indicated Staged Laparotomies in Abdominal Trauma

NCT07110350 | Not Yet Recruiting DMC

• 1 other identifier: FEMH_Treauma_114107-E
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to understand how often staged operations are performed in abdominal trauma patients without meeting standard clinical criteria, and to explore related clinical characteristics and outcomes. The main questions it aims to answer are: How frequently are staged operations performed when not clinically indicated? What are the clinical features and outcomes of patients who undergo non-indicated staged operations? What are the risk factors for delayed reoperation among patients who initially received a single operation? Researchers will review medical records of patients who underwent exploratory laparotomy for abdominal trauma at Far Eastern Memorial Hospital between January 1, 2013, and December 31, 2024. Participants will be grouped based on whether they had a single or staged operation, and whether their initial operation met established criteria for a staged approach. Clinical characteristics and outcomes will be compared across groups.

Conditions

Abdominal Trauma; Damage Control Surgery; Laparotomy

Outcome Measures

Primary Outcomes (1)

• death

  The primary outcome is defined as all-cause mortality occurring no earlier than 24 hours after the most recent surgical intervention.

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (1)

• Complications

  through study completion, an average of 1 year

Study Arms (1)

single vs. staged operation

Patients will be categorized based on the number of operations (single vs. staged), and further stratified by whether the initial operation met the criteria for a staged approach.

Procedure: Laparotomy refers to a definitive single-stage exploratory abdominal surgery. Damage Control Surgery refers to a staged surgical approach including initial abbreviated laparotomy followed by planned.

Interventions

Laparotomy refers to a definitive single-stage exploratory abdominal surgery. Damage Control Surgery refers to a staged surgical approach including initial abbreviated laparotomy followed by planned. PROCEDURE

This intervention involves exploratory laparotomy performed for abdominal trauma at a single tertiary care trauma center in Taiwan between 2013 and 2024. Patients are stratified based on whether they received a single definitive laparotomy or staged damage control surgery. Staged surgery is defined as an abbreviated initial laparotomy followed by planned reoperation(s), regardless of whether physiological indications were strictly met. This study specifically investigates the discrepancy between guideline-based indications and actual surgical practice.

single vs. staged operation

Eligibility Criteria

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

Study Population

The study population includes patients with abdominal trauma who were admitted to Far Eastern Memorial Hospital between January 1, 2013, and December 31, 2024, and underwent exploratory laparotomy. Patients under 18 years of age, those with pre-hospital or in-hospital cardiac arrest, those with an Abbreviated Injury Scale (AIS) score ≥ 4 in non-abdominal regions, and those who died within 24 hours after the latest surgery were excluded.

You may qualify if:

• This study included patients with abdominal trauma who were admitted to Far Eastern Memorial Hospital and received exploratory laparotomy between January 1, 2013, and December 31, 2024.

You may not qualify if:

• Patients who experienced cardiac arrest prior to hospital arrival (OHCA) or in-hospital cardiac arrest (IHCA).
• Patients with an Abbreviated Injury Scale (AIS) score ≥ 4 in any body region other than the abdomen.
• Patients who died within 24 hours after the most recent surgical procedure.

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Estern Memorial Hospital

New Taipei City, 220, Taiwan

Location

MeSH Terms

Conditions

Abdominal Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Chien Wu, MD

  Department of Surgery, Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien Wu, M.D.

CONTACT

+886 966782715; wu.chien0215@gmail.com

Heng Fu Lin, M.D.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: August 7, 2025
• Study Start: August 15, 2025
• Primary Completion: September 30, 2025
• Study Completion: November 30, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

TW (1)