imageBy Christina Frangou

San Diego—Adding robotic assistance to laparoscopic gastric bypass may lead to a slight reduction in complications compared with conventional laparoscopy, in the first 30 days after surgery, according to the largest reported series of robotics in bariatric surgery.

“This study suggests that, with robotics, we can take an already extremely safe operation and make it even safer, and perhaps more cost-effective with the reduction we’re seeing in complications,” said lead author Erik Wilson, MD, metabolic and bariatric surgeon at the University of Texas Health Science Center at Houston and Memorial Hermann-Texas Medical Center.

He presented the study at the 2012 annual meeting of the American Society for Metabolic and Bariatric Surgery.

Dr. Wilson and his colleagues reviewed outcomes for 1,695 consecutive patients who underwent robotic-assisted laparoscopic gastric bypass surgery at the University of Texas Health Science Center at Houston (n=578), the Eastern Maine Medical Center, Bangor (n=708) and Florida Hospital Celebration Health, Celebration (n=409).

All patients underwent surgery performed with the da Vinci Surgical System (Intuitive Surgical) between 2003 and 2011 and had an average preoperative body mass index of 48 kg/m2.

AT A GLANCE

The study showed a mortality rate slightly below the 0.2% often cited for laparoscopic gastric bypass.

The robot costs more than $1 million, with an additional $1,000 to $1,400 for instruments per case.

Operative times for robotic gastric bypass are now comparable to laparoscopy, according to researcher.

No patient died within the first 30 days after surgery; the study showed a mortality rate slightly below the 0.2% often cited for laparoscopic gastric bypass, based on a study of hospitals in Michigan (JAMA 2010;304:435-442).

Major morbidity was reported in 1.5% of patients, and included three anastomotic leaks (0.12%), three abscess leaks (0.18%) and 14 bleeds requiring transfusions. Four patients had early strictures diagnosed (0.2%).

In April, the American College of Surgeons Bariatric Surgery Center Network Accreditation Program reported a 30-day mortality rate of 0.14% and a morbidity rate of 5.02% among 14,491 patients who underwent laparoscopic gastric bypass between 2007 and 2009 (Ann Surg 2011;254:410-420).

But it is misleading to compare the robotic series with previously published studies. The patients are not matched, the surgeon experience is not matched, and the robotic series represents only a very small number of patients compared with the patients in the national bariatric database.

Even so, surgeons said the new report shows conclusively that the robot is a safe and effective tool for minimally invasive surgery in bariatric patients.

“This report shows that, in the hands of experienced robotic surgeons, the robotic is certainly as safe, and perhaps safer, than the laparoscopic approach,” said Ranjan Sudan, MD, a bariatric and robotic surgeon and vice-chair of education, Duke University Health System, Durham, N.C. Dr. Sudan performed the first robotic bariatric surgery in 2000.

However, neither this study, nor any of the previously published studies of robotic bariatric surgery, shows an advantage of using the robot, he said.

Robotic surgery is more expensive and more time-consuming, particularly early in the surgeon’s learning curve compared with conventional laparoscopy. The robot costs more than $1 million to purchase, with an additional $1,000 to $1,400 for instruments per case.

Studies will have to show a conclusive advantage for using the robot if it is going to gain widespread acceptance in bariatric surgery during an era of increased consciousness about health care costs, Dr. Sudan said. “We need research that compares the outcomes, the patient benefits, the ergonomics (for the surgeon) and the cost. Until we have that, we are not going to be able to convince anyone that the robot is much better.”

In this series, surgeons at the three centers performed a robotic-assisted procedure. One surgeon sat away from the operating table at a console, where he or she manipulated two robotic arms to perform surgery. At the Maine hospital, surgeon Michelle Toder used a three-port technique and performed the operation in conjunction with a very skilled physician assistant. In Texas and Florida, surgeons performed an operation that is more of a “one-person surgery.” All aspects of the procedure other than stapling were performed through the robot. (The robot does not have stapling capabilities so this is performed through the port).

Eighty-one patients (4.8%) required readmission to hospital after surgery and 46 (2.7%) underwent reoperation. Reasons for reoperation included bowel obstruction in 17 patients, infection in five patients, bleeding in 18 patients and negative explorations in six patients.

The mean operating time varied among the three centers. The average time was 156 minutes in Texas, where all cases were teaching cases. In Orlando, operative times dropped to 128 minutes and in Maine, where all cases were done at a private hospital, operative times averaged 104 minutes.

According to Dr. Wilson, operative times are decreasing and now reach about 90 minutes in Texas, nearly half of what it was in 2003, and in Maine, operative times are less than 60 minutes. “Operative times are now comparable to what you can do laparoscopically,” he said.

Several authors have tried to compare robotic and laparoscopic surgery using published prospective studies. The largest, a systematic review published last fall, found patients who were operated on with a robot had a significantly reduced incidence of anastomotic stricture in the robotic group (pooled odds ratio, 0.43; 95% confidence interval, 0.19-0.98; P=0.04). Investigators found no significant difference between robotic and laparoscopic groups for anastomotic leak, postoperative complications, operative time and hospital length of stay (Int J Med Robot 2011;7:393-400). The findings were based on an analysis of seven studies comparing robotic and laparoscopic Roux-en-Y gastric bypass in 1,686 patients.

Some experts said that it is unlikely a randomized trial will ever be performed that could measure between robotic and laparoscopic surgery. Any differences between the two procedures are small and to quantify the differences would require a trial involving thousands of patients.

Dr. Wilson disclosed that he is a consultant for Apollo Endosurgery, EndoGastric Solutions, Ethicon Endo-Surgery and Intuitive Surgical; a proctor for Intuitive Surgical; and the recipient of an educational grant from Gore. Dr. Sudan reported no relevant disclosures.