Enteric Anastomoses

March 18, 2026 updated by: Methodist Health System

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All trauma patients at Methodist Dallas Medical Center (MDMC) diagnosed with traumatic colon injury and meets registry inclusion

Description

Inclusion Criteria:

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)

Exclusion Criteria:

<18 years old Prisoners, pregnant persons, or other protected population.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Medical/Phenotype Data Collection Procedures & Data to be Collected
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number and Description 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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Andrew Karpisek, MD, Methodist Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 051.TRA.2023.D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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