Status:
COMPLETED
Damage Control Laparotomy
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Other Injury of Other Intra-abdominal Organs, Initial Encounter
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
Randomized study to compare outcomes of patients undergoing damage control laparotomies versus definitive closure for which there is surgeon equipoise to randomize.
Detailed Description
Single center, prospective, randomized study involving seriously injure patients requiring an emergent laparotomy within 90 minutes of arrival to the emergency department. There are situations in whic...
Eligibility Criteria
Inclusion
- Emergent laparotomy
- 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
- Indication for DCL for which there is no surgeon equipoise:
- 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
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT02706041
Start Date
July 1 2016
End Date
April 30 2020
Last Update
November 18 2021
Active Locations (1)
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1
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, United States, 77030