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Not yet recruiting NCT07110350

Clinical Outcomes of Non-Indicated Staged Laparotomies in Abdominal Trauma

Observational Abdominal Trauma Damage Control Surgery Laparotomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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..
Who it may be relevant to
Registry conditions: Abdominal Trauma, Damage Control Surgery, Laparotomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinical Characteristics and Outcomes of Non-Indicated Staged Laparotomies in Abdominal Trauma Patients: A Single-Center Retrospective Study

Overview

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.

Detailed description

Background:

Staged operation, a key component of damage control surgery, is typically indicated for trauma patients with physiological instability, including hypotension, hypothermia, metabolic acidosis, or coagulopathy. However, deviations from these criteria are frequently observed in clinical practice, raising concerns about discrepancies between guidelines and surgical decisions, and the potential for overuse.

Objective:

This study aims to investigate the disparity between clinical indications and actual use of staged operations in patients with abdominal trauma, and to explore associated clinical characteristics and possible prognostic implications.

Methods:

A retrospective review will be conducted on patients who underwent exploratory laparotomy for abdominal trauma at Far Eastern Memorial Hospital between January 1, 2013, and December 31, 2024. 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. Among those not meeting the criteria, clinical features and outcomes will be compared. Additionally, risk factors for delayed reoperation in initially single-operation patients will be evaluated.

Interventions

  • 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.
    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

Primary outcome measures

  • death [Time frame: From enrollment to the end of treatment at 6 months]
Secondary outcome measures (1)
  • Complications [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Taiwan · 1 center
  • Far Estern Memorial Hospital — New Taipei City

Identifiers

NCT: NCT07110350 · FEMH_Treauma_114107-E

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗