Clinical Outcomes of Non-Indicated Staged Laparotomies in Abdominal Trauma

Not yet recruiting

• Conditions: Abdominal Trauma; Laparotomy; Damage Control Surgery

• Registration Number: NCT07110350
• Lead Sponsor: Far Eastern Memorial Hospital

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.

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-07
• Study Start: 2025-08-15
• Primary Completion: 2025-09-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
death	From enrollment to the end of treatment at 6 months	The primary outcome is defined as all-cause mortality occurring no earlier than 24 hours after the most recent surgical intervention.

Secondary Outcome Measures

Name	Time	Method
Complications	through study completion, an average of 1 year	Secondary outcomes included postoperative complications such as ileus, infection, poor wound healing, and incisional hernia.

Trial Locations

Locations (1)

Far Estern Memorial Hospital; 🇨🇳 New Taipei City, Taiwan