CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
Definitive Closure Laparotomy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02706041
NCT02706041N/ACompleted
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Damage Control Laparotomy: A Randomized Controlled Trial

The University of Texas Health Science Center, Houston·interventional·Posted Mar 11, 2016·Updated Nov 18, 2021

In Brief

A clinical study evaluating Definitive Closure Laparotomy and Damage Control Laparotomy for Other Injury of Other Intra-abdominal Organs, Initial Encounter. Completed, enrolled 39 participants across 1 site.

Detailed Summary

Randomized study to compare outcomes of patients undergoing damage control laparotomies versus definitive closure for which there is surgeon equipoise to randomize.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOther Injury of Other Intra-abdominal Organs, Initial Encounter
CountriesUnited States
CollaboratorsNational Center for Advancing Translational Sciences (NCATS)

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 11, 2016
Enrollment StartJul 1, 2016
Primary CompletionNov 30, 2019
Study CompletionApr 30, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.3 years ago

Interventions

Definitive Closure Laparotomyprocedure

Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.

Damage Control Laparotomyprocedure

Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.