NCT07490158

Brief Summary

This retrospective data repository will serve as a means to aggregate and analyze best practices as relative to traumatic colon injury outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Feb 2026Jan 2028

Study Start

First participant enrolled

February 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

March 24, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

March 18, 2026

Last Update Submit

March 18, 2026

Conditions

Trauma

Outcome Measures

Primary Outcomes (1)

  • Total Number and Description of Study Sites

    This study will include all trauma patients at Methodist Dallas Medical Center diagnosed with traumatic colon injury and meets registry inclusion.

    5 years

Study Arms (1)

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

Interventions

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.

Total Number and Description of Study Sites/Total Number of Subjects Projected

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center- Clinical Research Institute

Dallas, Texas, 75203, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Andrew Karpisek, MD

    Methodist Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystee Cooper, DHEd

CONTACT

214-947-1280ClinicalResearch@mhd.com

Kavya Mankulangara

CONTACT

214-947-4604ClinicalResearch@mhd.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

March 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL

Locations

US(1)