TraumaNCT07490158
Enteric Anastomoses
An observational study of Trauma, run by Methodist Health System at 1 site in United States.
Trial summary
This retrospective data repository will serve as a means to aggregate and analyze best practices as relative to traumatic colon injury outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- Medical/Phenotype Data Collection Procedures & Data to be Collected
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2024to Jan 2028
- How long will I take part?
- 5 Years
- 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
- Adult, Older adult
Study population: All trauma patients at Methodist Dallas Medical Center (MDMC) diagnosed with traumatic colon injury and meets registry inclusion
Who may be able to join
- 18 years old Included in the MDMC(Methodist Dallas Medical Center) Trauma Registry Any diagnosis code indicative of injury to the large and/or small bowel (S36.5 and/or S36.4)
Who cannot join
- <18 years old Prisoners, pregnant persons, or other protected population.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Methodist Dallas Medical Center- Clinical Research Institute
Dallas, Texas, 75203
Colette Ngo Ndjom, 214-947-1289, ClinicalResearch@mhd.com
Kavya Mankulangara, 214-947-4604, ClinicalResearch@mhd.com
About this study
Official title: Enteric Anastomoses in Trauma
This retrospective data repository will serve as a means to aggregate and analyze best practices as relative to traumatic colon injury outcomes.
Read the detailed description
The primary objective of this study is to establish a data repository that will be permissive of quality improvement studies/observations specific to traumatic colon injuries and evaluate current surgical management as treatment, specifically comparing initial primary anastomosis, delayed anastomosis, and ostomy diversion outcomes.
- Conditions
- Trauma
- Being tested
- Medical/Phenotype Data Collection Procedures & Data to be Collected
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical/Phenotype Data Collection Procedures & Data to be CollectedOther
The Methodist Dallas Medical Center Trauma Registry will be queried for demographic information, diagnosis codes, admission dates, traumatic injury characteristics, surgical procedures, comorbidities, inpatient outcomes, complications, consultations, discharge location, and mortality. Additional laboratory values will be abstracted from Epic through retrospective chart review.
| Study group | Role | What they receive |
|---|---|---|
| Total Number and Description of Study Sites/Total Number of Subjects Projected | Include all trauma patients at Methodist Dallas Medical Center (MDMC) diagnosed with traumatic colon injury and meets registry inclusion. Enrollment will terminate once five years of data are captured: January 2018 through December 2023. Receives: Other: Medical/Phenotype Data Collection Procedures & Data to be Collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Study Sites
This study will include all trauma patients at Methodist Dallas Medical Center diagnosed with traumatic colon injury and meets registry inclusion.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start16 Feb 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Karpisek, MD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490158
- Sponsor's protocol ID
- 051.TRA.2023.D
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All information will be blinded in compliance with Good Clinical Practice. The investigator will make all possible efforts to ensure compliance with all policies regarding sharing of protected health information or research information. Only de-identified protected health information will be shared in relevant research mediums.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteric Anastomoses in Trauma
- ClinicalTrials.gov ID
- NCT07490158
- Acronym / sponsor ID
- 051.TRA.2023.D
- Conditions
- Trauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 24 Mar 2026 (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.
This retrospective data repository will serve as a means to aggregate and analyze best practices as relative to traumatic colon injury outcomes.
Detailed description
The primary objective of this study is to establish a data repository that will be permissive of quality improvement studies/observations specific to traumatic colon injuries and evaluate current surgical management as treatment, specifically comparing initial primary anastomosis, delayed anastomosis, and ostomy diversion outcomes.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Number and Description of Study Sites/Total Number of Subjects Projected | – | Other: Medical/Phenotype Data Collection Procedures & Data to be CollectedInclude all trauma patients at Methodist Dallas Medical Center (MDMC) diagnosed with traumatic colon injury and meets registry inclusion. Enrollment will terminate once five years of data are captured: January 2018 through December 2023. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All trauma patients at Methodist Dallas Medical Center (MDMC) diagnosed with traumatic colon injury and meets registry inclusion
Key inclusion criteria (1 listed)
- 18 years old Included in the MDMC(Methodist Dallas Medical Center) Trauma Registry Any diagnosis code indicative of injury to the large and/or small bowel (S36.5 and/or S36.4)
Key exclusion criteria (1 listed)
- <18 years old Prisoners, pregnant persons, or other protected population.
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 |
|---|---|---|
| Medical/Phenotype Data Collection Procedures & Data to be CollectedThe Methodist Dallas Medical Center Trauma Registry will be queried for demographic information, diagnosis codes, admission dates, traumatic injury characteristics, surgical procedures, comorbidities, inpatient outcomes, complications, consultations, discharge location, and mortality. Additional laboratory values will be abstracted from Epic through retrospective chart review. | Other | Total Number and Description of Study Sites/Total Number of Subjects Projected |
Primary outcome
Total Number of Study Sites
Time frame: 5 years
This study will include all trauma patients at Methodist Dallas Medical Center diagnosed with traumatic colon injury and meets registry inclusion.
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 10 Jun 2026.
- Individual participant dataSharing planned: Yes. All information will be blinded in compliance with Good Clinical Practice. The investigator will make all possible efforts to ensure compliance with all policies regarding sharing of protected health information or research information. Only de-identified protected health information will be shared in relevant research mediums.
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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.
Andrew Karpisek, MD principal investigator
Methodist Health System
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 Trauma, run by Methodist Health System at 1 site in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. 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 United States. 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 Crystee Cooper, DHEd (214-947-1280, ClinicalResearch@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Study Sites (time frame: 5 years). 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 10 Jun 2026.