Robotic Surgery Linked to Higher Rates of Bile Duct Injury in Cholecystectomies: Study

Not only did patients face a higher risk of experiencing a bile duct injury during robotic surgery, but also faced an increased risk of other complications requiring additional procedures.

The findings of a new study raise questions about the safety of robotic gallbladder removal surgeries, suggesting that patients may be more likely to experience serious health complications compared to those undergoing other minimally invasive procedures.

In a report recently published in the medical journal JAMA Network Open, researchers from the University of Michigan and the University of California indicate that patients who received robot-assisted cholecystectomy procedures faced a nearly 10% higher risk of suffering surgical complications than laparoscopic surgery recipients.

During robotic cholecystectomy surgery, doctors use complex, computerized machines with robotic arms, which allow them to remove the gallbladder through a single incision at the belly button. Laparoscopic cholecystectomies require 3-4 incisions, and surgeons use a thin tube with surgical tools and a small camera to perform the procedure.

Robotic surgery is often touted as a breakthrough and revolutionary treatment option that can help surgeons make more precise incisions and reduce pain, blood loss, infection, scarring, and recovery times. Researchers indicate that robotic-assisted cholecystectomy is becoming a more popular choice over traditional laparoscopic surgery, as use of the surgical method among the study participants increased more than 37 times between 2010 and 2019.

In this latest study, researchers analyzed the data of 1,026,088 Medicare patients who underwent gallbladder removal surgeries between 2010 and 2019, finding that 9.3% of patients who underwent robotic-assisted cholecystectomies suffered from a serious surgical complication, compared to 8.6% of laparoscopic cholecystectomy patients.

Robotic surgery caused a bile duct injury in 0.7% of patients and 7.4% sustained a severe injury that required an additional surgery to repair; compared to laparoscopic procedures, which caused bile duct injuries in only 0.2% of patients, with 6% requiring surgical intervention to repair.

“This cohort study found that, among Medicare beneficiaries, the use of robotic-assisted cholecystectomy increased from 2010 through 2019 and was associated with higher rates of bile duct injury compared with laparoscopic cholecystectomy,” the researchers concluded. “In the absence of other advantages over an already minimally invasive procedure, these data call into question the practice of robotic-assisted cholecystectomy.”

Robotic Surgery Safety Concerns

There have been concerns over the safety and effectiveness the robotic-assisted surgeries for years. A study conducted in 2020 revealed that patients who received robotic hernia repair surgery had even longer surgery times than those who had laparoscopic procedures, and both surgical methods had comparable recovery lengths, complication rates, and quality of life.

Another study also found that patients who underwent robotic, laparoscopic and traditional open surgeries had similar complication rates, and long-term health outcomes. Robotic surgeries took longer than other surgical methods as well, and had higher death rates among patients.

In August 2021, the U.S. Food and Drug Administration (FDA) issued an advisory to consumers, warning that the agency had not confirmed the safety or effectiveness of robotic mastectomy procedures for the prevention or treatment of breast cancer. Officials released the safety communication in response to several clinical studies that were using the surgical methods to prevent breast cancer without prior FDA approval.

While the FDA has approved robotic procedures to treat certain cancers, perform hysterectomies, prostatectomies and colectomies, researchers indicate the findings of this latest study prompt further research of whether robot-assisted cholecystectomies are safer or more effective than laparoscopic surgeries.