Damage Control Laparotomy (DCL) Trial
Frequently Asked Questions
- Who will be included in this study?
All patients presenting to Memorial Hermann-Texas Medical Center (MHH-TMC) with trauma requiring emergent laparotomy will be screened for eligibility for the study. Emergent laparotomy is defined as: (1) time in emergency department ≤90 minutes and (2) admission to the operating room directly from the emergency department. Patients meeting all inclusion criteria will be enrolled in the study.
- Emergent laparotomy
- Patient has injuries for which surgeon has equipoise to perform a DEF or DCL
- Age ≥16 years (age cut-off for admission to adult trauma service)
- 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 <90 mmHg, ongoing transfusion requirement, or continuous vasopressor use
- Indication for DEF for which there is no surgeon equipoise:
- Negative and non-therapeutic laparotomies
- Isolated cystorrhaphy
- Known pregnancy
- Patients with burns > 20% of total body surface area (resuscitation and treatment differs significantly from trauma patients without burns)
- Patient/legally authorized representative opted out of Exception from Informed Consent (opt out bracelet)
- How many patients will be enrolled?
A total of 56 patients will be enrolled over a two year period.
- When will the study start?
The projected start date of the study is October 1, 2016. The study is to run for 2 years and complete by September 30, 2018.
- Once the patient reaches the emergency department, why can’t family be contacted to provide consent?
For patients undergoing emergent laparotomy at MHH-TMC, the median time of a patient’s stay in the emergency department is 26 minutes. There simply isn’t enough time to both provide the timely care necessary and to obtain informed consent from family. After enrollment, every effort will be made to obtain informed consent for ongoing participation from the patient or the patient’s legally authorized representative.
- Are there any risks to the patient?
Any patient undergoing emergent laparotomy is at risk for a number of post-operative complications, such as infection, delayed intestinal function, incisional hernia, missed injuries, and bleeding. All studies attempting to determine the effect of DCL on these complications suffer significant bias. Thus, at this point, the effect of DCL on these complications is unknown and determining the effect is the goal of the study.
A committee composed of physicians, a statistician, and a former patient will meet every 6 months to review preliminary data from the study to assess for the potential of harm. If this committee feels that patients are being harmed by the study, the study will be halted at their recommendation.
- How can I opt out of this trial?
If you wish to not participate in this trial, please request an “opt out” bracelet. As many of the patients who will be enrolled in this study will be unconscious or otherwise unable to communicate with the team of surgeons treating them, the bracelet must be worn to indicate that you do not wish to be enrolled in the study. To request an opt-out bracelet, please see the “Opt Out of DCL Trial” tab to the left.