Clinical Outcomes of Non-Indicated Staged Laparotomies in Abdominal Trauma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFar Eastern Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
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/SurgeryThis 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.
Treatment groups
350 Participants
are divided into 1 treatment groupGroup A: single vs. staged operation1 intervention
Trial outcomes
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.
Time frame
From enrollment to the end of treatment at 6 monthsSecondary outcomes
1
Complications
Secondary outcomes included postoperative complications such as ileus, infection, poor wound healing, and incisional hernia.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov
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