Surgical Innovation Does Not Have to Threaten Patient Safety

July 14, 2014

New minimally invasive robotic surgical techniques may offer some benefit to patients, but only once surgeons pass the learning curve.

Is surgical safety surveillance needed? Yes, according to new research, which found an increased risk to patients during the adoption of minimally invasive robotic surgery. Granted, the surgery evaluated in the study was for the treatment of prostate cancer, but new techniques are new techniques.

The study authors cautioned that more standards, training, and credentialing are needed when adopting new surgical technologies. In terms of training for gynecological surgery, one program has already had proven success.

Pertinent Points

- After analyzing the clinical adoption of minimally invasive robotic prostatectomies, researchers found reason to support refining the process for using new surgical technology to improve patient safety.

- In 2005, the risks associated with radical prostatectomies were two times greater in patients who had the procedure done using minimally invasive robotic technology verses traditional open surgery.

- Better guidelines and training are needed when adopting new surgical technologies.

"This study looked at the stages of innovation and how the rapid adoption of a new surgical technology-in this case, a surgical robotic system-can lead to adverse events for patients," said Kellogg Parsons, MD, MHS, surgical oncologist, UC San Diego Health System and first author of the paper.

Parsons and colleagues found a two-fold increase in the adjusted odds ratio of patient safety indicators for minimally invasive radical prostatectomy when compared with open radical prostatectomy. But the increased risk was only found in 2005 and not in the other years in the study, which included 401,325 men who had the procedure between January 1, 2003, and December 31, 2009. This suggests that the risk to patients normalizes after the surgeons become experienced with the new techniques.

The results of the study were published online in JAMA Surgery on July 2. In an invited commentary, two physicians with the Department of Urology at Johns Hopkins University highlighted the fact that no other statistically significant differences between minimally invasive and open radical prostatectomies were uncovered. The commentators also suggested that more data was needed to fully evaluate the findings of the study, including looking at outcomes such as cancer recurrence and the effects on quality of life. Finally, they were critical that the study did not adjust for confounders, such as surgeon experience and disease characteristics.

Still, Parsons and colleagues suggested that as minimally invasive radical prostatectomies became more commonplace across the country with the advent of the da Vinci technology, there was a need to better protect patient safety. They concluded that the findings should inform the clinical adoption of other minimally invasive surgical technologies by refining the processes for training surgeons on new technologies.

"A responsibility of deploying a surgical technology should include the responsibility to monitor it as it diffuses throughout the real world to ensure safety," said David C. Chang, PhD, MPH, MBA, director of Outcomes Research at UC San Diego School of Medicine and the paper's senior author. "Surveillance of surgical safety should be ongoing, much like the Centers for Disease Control monitor changes in trends of infectious diseases across the country."