Abdominal TraumaNCT07110350
Clinical Outcomes of Non-Indicated Staged Laparotomies in Abdominal Trauma
An observational study of Abdominal Trauma and Damage Control Surgery, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Trauma, Damage Control Surgery, Laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Aug 2025to 30 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Heng Fu Lin, M.D. contact
Taiwan1 site
Far Estern Memorial Hospital
New Taipei City, 220
Cheng, +886 277282819, irb@mail.femh.org.tw
About this study
Official title: Clinical Characteristics and Outcomes of Non-Indicated Staged Laparotomies in Abdominal Trauma Patients: A Single-Center Retrospective Study
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?
Read more
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.
Read the 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
- Being tested
- 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.
- Medical subject headings
- Abdominal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
The primary outcome is defined as all-cause mortality occurring no earlier than 24 hours after the most recent surgical intervention.
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (1)
Complications
Secondary outcomes included postoperative complications such as ileus, infection, poor wound healing, and incisional hernia.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chien Wu, MD, Principal investigator, Department of Surgery, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110350
- Sponsor's protocol ID
- FEMH_Treauma_114107-E
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Outcomes of Non-Indicated Staged Laparotomies in Abdominal Trauma Patients: A Single-Center Retrospective Study
- ClinicalTrials.gov ID
- NCT07110350
- Acronym / sponsor ID
- FEMH_Treauma_114107-E
- Conditions
- Abdominal Trauma, Damage Control Surgery, Laparotomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single vs. staged operation | – | 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.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | single vs. staged operation |
Primary outcome
death
Time frame: 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.
1 secondary outcome
Complications
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heng Fu Lin, M.D. contact
Chien Wu, MD principal investigator
Department of Surgery, Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Trauma and Damage Control Surgery, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chien Wu, M.D. (+886 966782715, wu.chien0215@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.