Clinical Characteristics and Outcomes of Non-Indicated Staged Laparotomies in Abdominal Trauma Patients: A Single-Center Retrospective Study
Conditions: Abdominal Trauma, Damage Control Surgery, Laparotomy
Sponsor: Far Eastern Memorial Hospital

Study Protocol 
Official Title: Clinical Characteristics and Outcomes of Non-Indicated Staged Laparotomies in Abdominal Trauma 
Patients: A Single-Center Retrospective Study 
NCT Number: [Pending] 
Document Date: 2025-08-03 
Principal Investigator: Chien Wu, M.D. 
Affiliation: Department of Surgery, Far Eastern Memorial Hospital 
 
1. Study Overview 
This retrospective observational study aims to investigate the clinical characteristics and outcomes of abdominal 
trauma patients who received staged laparotomies without meeting conventional indications. The study will 
analyze differences in patient outcomes, risk factors, and the potential implications of deviating from guideline-
based indications. 
2. Study Dates 
Start Date: 2013-01-01 
End Date: 2024-12-31 
3. Study Population 
Patients who underwent exploratory laparotomy for abdominal trauma at Far Eastern Memorial Hospital between 
January 1, 2013, and December 31, 2024. 
4. Study Design 
This is a single-center, retrospective observational cohort study. Patients will be grouped by surgical approach 
(single vs. staged laparotomy) and whether the initial operation met staged surgery criteria. 
5. Objectives 
To assess the frequency, clinical characteristics, and outcomes associated with non-indicated staged laparotomies. 
6. Outcomes 
Primary Outcome: 
- 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 months] 
Secondary Outcomes: 
- Postoperative complications including ileus, infection, poor wound healing, and incisional hernia. 
[Time Frame: through study completion, an average of 1 year] 
 
 

Statistical Analysis Plan 
Official Title: Clinical Characteristics and Outcomes of Non-Indicated Staged Laparotomies in Abdominal Trauma 
Patients: A Single-Center Retrospective Study 
NCT Number: [Pending] 
Document Date: 2025-08-03 
Principal Investigator: Chien Wu, M.D. 
Affiliation: Department of Surgery, Far Eastern Memorial Hospital 
 
1. Statistical Analysis Overview 
This document outlines the statistical methods used to analyze clinical and outcome differences among patients 
who received indicated vs. non-indicated staged laparotomies. 
2. Primary Analysis 
The primary analysis will evaluate all-cause mortality occurring after surgical intervention using logistic 
regression models. 
3. Secondary Analyses 
Secondary outcomes including complications (e.g., ileus, infection) will be analyzed using univariate and 
multivariate logistic regression. 
4. Statistical Methods 
- Mann–Whitney U test for continuous variables 
- Logistic regression for binary outcomes 
- Propensity score matching to reduce confounding between comparison groups 
5. Software 
Statistical analyses will be performed using STATA version XX (replace with actual version used).