Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2016-07-01
2020-04-30
Brief Summary
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Detailed Description
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The eligible subjects for this study will be randomized toward the end of the emergent laparotomy procedure on a 1:1 basis and will be followed throughout the hospitalization for complications. Patients will also be contacted at 6 month to complete a quality of life questionnaire.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Definitive closure laparotomy
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Damage control laparotomy
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.
Damage Control Laparotomy
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.
Interventions
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Definitive Closure Laparotomy
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Damage Control Laparotomy
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.
Eligibility Criteria
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Inclusion Criteria
* Patient has injuries for which surgeon has equipoise to perform a Definitive (DEF) or Damage Control Laparotomy (DCL)
* Age ≥16 years (age cut-off for admission to adult trauma service at Memorial Hermann Hospital-Texas Medical Center)
Exclusion Criteria
* Need for gauze packing of liver or retroperitoneum for hemorrhage control
* Immediate need to go to Interventional Radiology for hemorrhage control
* Concern for Abdominal Compartment Syndrome - defined as physically unable to re-approximate fascia or \>10mmHg change in peak airway pressure during fascial closure
* Hemodynamic instability - defined as persistent hypotension, ongoing transfusion requirement, or continuous vasopressor use
* Indication for DEF for which there is no surgeon equipoise:
* Negative and non-therapeutic laparotomies
* Isolated cystorrhaphy
* Prisoners
* Known pregnancy
* Patients with burns \> 20% of total body surface area
* Patient/legally authorized representative opted out of exception from informed consent (opt out bracelet)
* Currently enrolled in another interventional study
16 Years
ALL
No
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
NIH
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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John Andrew Harvin
MD
Principal Investigators
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John Harvin, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, United States
Countries
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References
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Harvin JA, Podbielski J, Vincent LE, Fox EE, Moore LJ, Cotton BA, Wade CE, Holcomb JB. Damage control laparotomy trial: design, rationale and implementation of a randomized controlled trial. Trauma Surg Acute Care Open. 2017 Apr 13;2(1):e000083. doi: 10.1136/tsaco-2017-000083. eCollection 2017.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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