Using an innovative quality improvement project to determine how to design an effective emergency trauma clinical trial, a team of surgeons at McGovern Medical School was able to launch the first-ever study on a high-risk damage control surgery for critical abdominal injuries.
The two-year quality improvement (QI) project was aimed at decreasing the rate of damage control laparotomies (DCL), which are staged procedures commonly used to control major bleeding and prevent contamination in emergency trauma patients with severe abdominal wounds. A Viewpoint article detailing how the project led to the clinical trial was published recently in the print edition of JAMA. Co-authors of the article were John Harvin, M.D., associate professor of surgery; Susan Wootton, M.D., associate professor of pediatrics; and Charles Miller, Ph.D., associate vice president for clinical research and health care quality.
DCL has proven to be a lifesaving technique, both in military and civilian trauma, but a 2017 UTHealth study published in the Journal of Trauma and Acute Care Surgery showed it has been associated with deadly postoperative complications. The study revealed that despite perceived improvements in care of an injured emergency trauma patient, mortality for the most severely injured subgroup—those with an arrival blood pressure less than 90 mm Hg—has been unchanged over the past two decades.
The quality improvement project reduced the rate of DCLs by 15 percent, and helped identify when the benefits of the surgery outweigh the risk.
“One of many reasons for the lack of improvement in mortality is the limited amount of high-quality research on acute trauma,” said Harvin, who is an attending physician at Memorial Hermann-Texas Medical Center. “Clinical trials provide the most rigorous evidence, but are logistically difficult to conduct, as well as expensive. DCLs not only carry a risk of postoperative complication, but they also are more costly for patients, as they require two procedures. As we saw DCL being used more frequently with little research being conducted on its effectiveness, we knew we had to find a way to bridge the gap.”
During a DCL, the surgeon places a temporary dressing over the intestines and leaves the abdominal wall open until the patient can be resuscitated, which usually occurs within 24 hours, and returned to the operating room for definitive repairs and abdominal closure.
To address the perceived DCL overuse, the surgical team initiated the two-year QI project, which included the transparent publication of surgeon-specific rates of DCL within the group, outcomes of all patients compared with historical averages and a novel form of audit-and-feedback. To give feedback regarding specific instances in which DCL was chosen, trauma surgeons met monthly and reviewed the details of, and indications for, every DCL since the previous meeting. Following review, surgeons voted on whether the DCL was appropriate, or if the patient may have safely been treated with a definitive laparotomy, which is when the abdominal wall is closed. The result was provided to the operating surgeon.
“This QI project was unique because it required surgeons to hear feedback about decisions they made and work they had done,” Harvin said. “In order to progress in standards of care, we must be willing to explore areas where we can improve and be vulnerable enough to hear criticism in order to gain powerful knowledge for the industry moving forward. The QI project allowed us to not only reduce our rate of DCL, but it paved the way for us to come to consensus regarding indications for DCL and gave us baseline data for rates of the surgery and outcomes, which laid the groundwork for the logistics of the clinical trial.”
If a patient needs an emergency laparotomy, the project revealed that 21 percent of those patients would fall into a gray area where it is not clear whether the abdominal injury should be left open or closed. Those patients are being enrolled in the ongoing clinical trial at UTHealth and Memorial Hermann-Texas Medical Center that is investigating if DCL causes postoperative complications. The comparative effectiveness trial is randomized, controlled and unblinded. Once a patient is determined eligible, the surgeon receives an envelope that directs them to perform either a DCL or definitive laparotomy.
For more information on the ongoing research, visit: https://clinicaltrials.gov/ct2/show/NCT02706041?cond=DCL&rank=2.