Clinical trial NCT02706041: Damage Control Laparotomy
Official title: Damage Control Laparotomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Injury of Other Intra-abdominal Organs, Initial Encounter
Keywords: Exploratory Lap (Ex Lap)
Damage Control Laparotomy (DCL)
Definitive
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2016-03-11
Enrollment: 39
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 which the patient is unable to be closed at the end of the emergent laparotomy (identified as damage control) and there are situations in which the injury has been treated and the incision can be closed (definitive). There are also situations where it is not clear if the patient should be kept open or closed and the result of the surgery varies based on the surgeon performing the case.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of Participants Who Died or Had Major Abdominal Complication (MAC)
timeFrame: 30 days
Secondary outcomes:
measure: Number of Participants With Non-abdominal Morbidities
timeFrame: 30 days
measure: Number of Hospital-free Days
timeFrame: 30 days
measure: Number of ICU-free Days
timeFrame: 30 days
measure: Number of Ventilator-free Days
timeFrame: 30 days
measure: Hospital Costs
timeFrame: 30 days
measure: Patient-centered Outcomes Assessed Using the Standard Gamble
timeFrame: at discharge from hospital (about 20 days after intervention)
measure: Patient-centered Outcomes Assessed Using the Standard Gamble
timeFrame: 6 months after discharge from hospital
measure: Patient-centered Outcomes Assessed Using the 5-level European Quality of Life Scale-5D (EuroQol-5D-5L)
timeFrame: at discharge from hospital (about 20 days after intervention)
measure: Patient-centered Outcomes Assessed Using the 5-level European Quality of Life Scale-5D (EuroQol-5D-5L)
timeFrame: 6 months after discharge from hospital
measure: Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C)
timeFrame: at discharge from hospital (about 20 days after intervention)
measure: Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C)
timeFrame: 6 months after discharge from hospital
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital - Texas Medical Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: John Harvin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.