Clinical Outcomes of Non-Indicated Staged Laparotomies in Abdominal Trauma

NCT ID: NCT07110350

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2025-11-30

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.

Conditions

Abdominal Trauma; Damage Control Surgery; Laparotomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

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.

Intervention Type: 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.

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.

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chien Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Far Eastern Memorial Hospital

Locations

Far Estern Memorial Hospital

New Taipei City, , Taiwan

Countries

Taiwan

Central Contacts

Chien Wu, M.D.

Role: CONTACT

wu.chien0215@gmail.com

+886 966782715

Heng Fu Lin, M.D.

Role: CONTACT

Facility Contacts

Cheng

Role: primary

irb@mail.femh.org.tw

+886 277282819

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FEMH_Treauma_114107-E

Identifier Type: -

Identifier Source: org_study_id