Damage Control Laparotomy
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 10/12/2018 |
| Start Date: | June 2016 |
| End Date: | April 2020 |
| Contact: | John Harvin, MD |
| Email: | John.Harvin@uth.tmc.edu |
| Phone: | 713-500-7292 |
Damage Control Laparotomy: A Randomized Controlled Trial
Randomized study to compare outcomes of patients undergoing damage control laparotomies
versus definitive closure for which there is surgeon equipoise to randomize.
versus definitive closure for which there is surgeon equipoise to randomize.
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.
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.
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
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: John Harvin, MD
Phone: 713-500-6407
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