In the Journals

Robotic-assisted surgery shows limited benefit for various cancers

In Gab Jeong

Robotic-assisted surgery did not appear superior to laparoscopic surgery for the treatment of patients with kidney cancer and rectal adenocarcinoma, according to results of two studies published in JAMA.

David Jayne, MD, professor of surgery and honorary consultant surgeon at Leeds Institute of Biomedical & Clinical Sciences in the United Kingdom, and colleagues of the randomized ROLARR clinical trial showed that robotic-assisted surgery did not reduce the risk for conversion to open laparotomy compared with conventional laparoscopic surgery among patients undergoing rectal adenocarcinoma resection.

In a retrospective cohort study by In Gab Jeong, MD, PhD, associate professor in the department of urology at Asan Medical Center in Seoul, Korea and visiting scholar at Stanford University, robotic-assisted surgery prolonged operating time and accrued higher hospital costs among patients with kidney cancer.

“The rapid increase in costly robotic surgery in lieu of laparoscopic surgery without a definite advantage for the patient is a problem that can be applied not only to the urological field but also to the entire surgical field,” Jeong told HemOnc Today. “This may lead to a huge increase in the cost of medical care that can be a significant burden on the health care system and, thus, requires constant monitoring.”

Robotic-assisted radial nephrectomy

Radical nephrectomy remains the standard of care for large tumors in renal cancer. The use of robotic surgery in urological practice has increased over time and has rapidly replaced conventional laparoscopy-type surgeries for many procedures.

“It is rapidly spreading in the medical field due to various reasons such as marketing of the company, patient’s preference for the latest technology and recommendations of the hospital [and] doctors,” Jeong said.

However, substantial cost increases for these procedures have not led to significantly improved outcomes.

Because questions and concerns remained about the costs and overall benefit of robotic-assisted surgeries, Jeong and colleagues evaluated how the use of robotic-assisted radical nephrectomy and laparoscopic radical nephrectomy changed between 2003 and 2015.

The analysis included 23,753 patients (mean age, 61.4 years; 58.1% men) who underwent laparoscopic surgery (n = 18,573) or robotic-assisted radical nephrectomy (n = 5,180) for renal mass.

The trend in use of robotic-assisted radical nephrectomy served as the primary outcome. Secondary outcomes included perioperative or major complications, resource use and direct hospital cost.

Jeong and colleagues found that the use of robotic-assisted surgery increased from 1.5% in 2003 to 27% in 2015 (P < .001).

Researchers observed no significant differences between robotic-assisted and laparoscopic radical nephrectomy for the incidence of any postoperative complications (22.2% vs. 23.4%; difference, –1.2%; 95% CI, –5.4 to 3) or major complications (3.5% vs. 3.8%; difference = –0.3%; 95% CI, –1 to 0.5).

A greater proportion of patients who underwent robotic-assisted surgery had operating time that lasted longer than 4 hours (46.3% vs. 25.8%; risk difference, 20.5%; 95% CI, 14.2-26.8).

Also, robotic-assisted surgery led to higher mean 90-day direct hospital costs ($19,530 vs. $16,851) attributed to operating room ($7,217 vs. $5,378) and supply costs ($4,876 vs. $3,891).

“The development and use of robotic platform might be helpful for patient care. However, scientific research on cost-effectiveness and safety has sometimes not been sufficiently conducted,” Jeong said. “For the patient, when choosing to receive robotic surgery, it is necessary to have enough consultation with the doctor and understand their advantages and disadvantages compared with the existing conventional laparoscopic surgery.”

Resection for rectal cancer

Laparoscopic surgery is commonly used for colon cancer, but its use is more controversial for rectal cancer. Clinical trials have led to conflicting results about the procedure’s benefits.

Jayne and colleagues sought to determine if robotic-assisted laparoscopic surgery reduced the risk for conversion to laparotomy compared with conventional laparoscopic surgery among patients with rectal cancer.

Researchers randomly assigned 471 patients (mean age, 64.9 years) to robotic-assisted surgery (n = 237) or conventional laparoscopic surgery (n = 234), performed by either upper or total rectum anterior resection or rectum and perineum resection.

Conversion to open laparotomy served as the primary endpoint. Secondary endpoints included intraoperative and postoperative complications, circumferential resection margin positivity, quality of life, bladder and sexual dysfunction, and oncological outcomes.

The overall rate of conversion to open laparotomy was 10.1%, which included 12.2% of patients assigned conventional laparoscopy and 8.1% assigned robotic-assisted laparoscopy.

The overall circumferential resection margin positivity rate was 5.7%, or 6.3% for conventional laparoscopy and 5.1% for robotic-assisted laparoscopy.

Researchers observed no significant differences in secondary outcomes between the groups.

“These findings suggest that robotic-assisted laparoscopic surgery, when performed by surgeons with varying experience with robotic surgery, does not confer an advantage in rectal cancer resection,” the researchers wrote.

Need for additional study

Although conducted in different disease states, the findings of these studies highlight similar trends associated with robotic-assisted surgery, Jason D. Wright, MD, chief of the division of gynecologic oncology at Columbia University Medical Center and Sol Goldman associate professor of gynecologic oncology at Columbia University College of Physicians and Surgeons, wrote in a related editorial.

“First, although robotically assisted surgery is usually associated with improved outcomes when compared with open procedures, the benefits of robotic-assisted surgery have been more difficult to document when compared with laparoscopic surgery,” Wright wrote. “... For procedures in which a minimally invasive laparoscopic procedure is already in use, there is often no meaningful incremental benefit in the use of robotic assistance in terms of complication rates or recovery.”

Still, the introduction of robotic-assisted surgery has increased the proportion of patients who undergo minimally invasive surgeries, Wright added.

Overall, assessing the efficacy of new devices and surgical techniques may present unique challenges compared with the introduction of a new drug, which occurs along a standard pathway.

“Many new procedures develop from a clinical need and diffuse into practice with limited formal assessment,” Wright wrote. “When evaluation does occur, reporting is often based on the demonstration of feasibility and not efficacy. Randomized trials comparing two procedures are difficult to undertake and subject to variation in surgeon experience and dependent on the operator and team setting.”

Thus, limitations in both studies warrant additional investigation of robotic-assisted surgery in these settings, Wright wrote.

“The report on radical nephrectomy by Jeong [and colleagues] ... is subject to selection bias, the influence of unmeasured confounders and misclassification of interventions and outcomes, whereas the study on rectal resection by Jayne [and colleagues] ... had a lower-than-expected rate of the primary outcome of conversion to laparotomy and included surgeons with different levels of experience for the two operations,” he wrote.

Without improved outcomes associated with robotic-assisted procedures, costs will become increasingly important. Reducing these costs could defer criticism of the procedure, according to Wright.

“As new robotic technologies enter the market, there is at least the potential that comes of the fixed costs associated with these procedures could be reduced,” he wrote. – by Melinda Stevens

References:

Jayne D, et al. JAMA. 2017;doi:10.1001/jama.2017.7219.

Jeong IG, et al. JAMA. 2017;doi:10.1001/jama.2017.14586.

Wright JD. JAMA. 2017;doi:10.1001/jama.2017.13696.

For more information:

In Gab Jeong, MD, PhD, can be reached at Department of Urology, Asan Medical Center, Univeristy of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea; email: igjeong@amc.seoul.kr.

Disclosures: Jayne reports a proctor role with Intuitive Surgical Inc. Please see the full study for a list of all other authors’ relevant financial disclosures. Jeong reports no relevant financial disclosures. One author reports personal fees from Intuitive Surgical. Wright reports consultant roles with Clovis Oncology and Tesaro.

In Gab Jeong

Robotic-assisted surgery did not appear superior to laparoscopic surgery for the treatment of patients with kidney cancer and rectal adenocarcinoma, according to results of two studies published in JAMA.

David Jayne, MD, professor of surgery and honorary consultant surgeon at Leeds Institute of Biomedical & Clinical Sciences in the United Kingdom, and colleagues of the randomized ROLARR clinical trial showed that robotic-assisted surgery did not reduce the risk for conversion to open laparotomy compared with conventional laparoscopic surgery among patients undergoing rectal adenocarcinoma resection.

In a retrospective cohort study by In Gab Jeong, MD, PhD, associate professor in the department of urology at Asan Medical Center in Seoul, Korea and visiting scholar at Stanford University, robotic-assisted surgery prolonged operating time and accrued higher hospital costs among patients with kidney cancer.

“The rapid increase in costly robotic surgery in lieu of laparoscopic surgery without a definite advantage for the patient is a problem that can be applied not only to the urological field but also to the entire surgical field,” Jeong told HemOnc Today. “This may lead to a huge increase in the cost of medical care that can be a significant burden on the health care system and, thus, requires constant monitoring.”

Robotic-assisted radial nephrectomy

Radical nephrectomy remains the standard of care for large tumors in renal cancer. The use of robotic surgery in urological practice has increased over time and has rapidly replaced conventional laparoscopy-type surgeries for many procedures.

“It is rapidly spreading in the medical field due to various reasons such as marketing of the company, patient’s preference for the latest technology and recommendations of the hospital [and] doctors,” Jeong said.

However, substantial cost increases for these procedures have not led to significantly improved outcomes.

Because questions and concerns remained about the costs and overall benefit of robotic-assisted surgeries, Jeong and colleagues evaluated how the use of robotic-assisted radical nephrectomy and laparoscopic radical nephrectomy changed between 2003 and 2015.

The analysis included 23,753 patients (mean age, 61.4 years; 58.1% men) who underwent laparoscopic surgery (n = 18,573) or robotic-assisted radical nephrectomy (n = 5,180) for renal mass.

The trend in use of robotic-assisted radical nephrectomy served as the primary outcome. Secondary outcomes included perioperative or major complications, resource use and direct hospital cost.

Jeong and colleagues found that the use of robotic-assisted surgery increased from 1.5% in 2003 to 27% in 2015 (P < .001).

PAGE BREAK

Researchers observed no significant differences between robotic-assisted and laparoscopic radical nephrectomy for the incidence of any postoperative complications (22.2% vs. 23.4%; difference, –1.2%; 95% CI, –5.4 to 3) or major complications (3.5% vs. 3.8%; difference = –0.3%; 95% CI, –1 to 0.5).

A greater proportion of patients who underwent robotic-assisted surgery had operating time that lasted longer than 4 hours (46.3% vs. 25.8%; risk difference, 20.5%; 95% CI, 14.2-26.8).

Also, robotic-assisted surgery led to higher mean 90-day direct hospital costs ($19,530 vs. $16,851) attributed to operating room ($7,217 vs. $5,378) and supply costs ($4,876 vs. $3,891).

“The development and use of robotic platform might be helpful for patient care. However, scientific research on cost-effectiveness and safety has sometimes not been sufficiently conducted,” Jeong said. “For the patient, when choosing to receive robotic surgery, it is necessary to have enough consultation with the doctor and understand their advantages and disadvantages compared with the existing conventional laparoscopic surgery.”

Resection for rectal cancer

Laparoscopic surgery is commonly used for colon cancer, but its use is more controversial for rectal cancer. Clinical trials have led to conflicting results about the procedure’s benefits.

Jayne and colleagues sought to determine if robotic-assisted laparoscopic surgery reduced the risk for conversion to laparotomy compared with conventional laparoscopic surgery among patients with rectal cancer.

Researchers randomly assigned 471 patients (mean age, 64.9 years) to robotic-assisted surgery (n = 237) or conventional laparoscopic surgery (n = 234), performed by either upper or total rectum anterior resection or rectum and perineum resection.

Conversion to open laparotomy served as the primary endpoint. Secondary endpoints included intraoperative and postoperative complications, circumferential resection margin positivity, quality of life, bladder and sexual dysfunction, and oncological outcomes.

The overall rate of conversion to open laparotomy was 10.1%, which included 12.2% of patients assigned conventional laparoscopy and 8.1% assigned robotic-assisted laparoscopy.

The overall circumferential resection margin positivity rate was 5.7%, or 6.3% for conventional laparoscopy and 5.1% for robotic-assisted laparoscopy.

Researchers observed no significant differences in secondary outcomes between the groups.

“These findings suggest that robotic-assisted laparoscopic surgery, when performed by surgeons with varying experience with robotic surgery, does not confer an advantage in rectal cancer resection,” the researchers wrote.

Need for additional study

Although conducted in different disease states, the findings of these studies highlight similar trends associated with robotic-assisted surgery, Jason D. Wright, MD, chief of the division of gynecologic oncology at Columbia University Medical Center and Sol Goldman associate professor of gynecologic oncology at Columbia University College of Physicians and Surgeons, wrote in a related editorial.

PAGE BREAK

“First, although robotically assisted surgery is usually associated with improved outcomes when compared with open procedures, the benefits of robotic-assisted surgery have been more difficult to document when compared with laparoscopic surgery,” Wright wrote. “... For procedures in which a minimally invasive laparoscopic procedure is already in use, there is often no meaningful incremental benefit in the use of robotic assistance in terms of complication rates or recovery.”

Still, the introduction of robotic-assisted surgery has increased the proportion of patients who undergo minimally invasive surgeries, Wright added.

Overall, assessing the efficacy of new devices and surgical techniques may present unique challenges compared with the introduction of a new drug, which occurs along a standard pathway.

“Many new procedures develop from a clinical need and diffuse into practice with limited formal assessment,” Wright wrote. “When evaluation does occur, reporting is often based on the demonstration of feasibility and not efficacy. Randomized trials comparing two procedures are difficult to undertake and subject to variation in surgeon experience and dependent on the operator and team setting.”

Thus, limitations in both studies warrant additional investigation of robotic-assisted surgery in these settings, Wright wrote.

“The report on radical nephrectomy by Jeong [and colleagues] ... is subject to selection bias, the influence of unmeasured confounders and misclassification of interventions and outcomes, whereas the study on rectal resection by Jayne [and colleagues] ... had a lower-than-expected rate of the primary outcome of conversion to laparotomy and included surgeons with different levels of experience for the two operations,” he wrote.

Without improved outcomes associated with robotic-assisted procedures, costs will become increasingly important. Reducing these costs could defer criticism of the procedure, according to Wright.

“As new robotic technologies enter the market, there is at least the potential that comes of the fixed costs associated with these procedures could be reduced,” he wrote. – by Melinda Stevens

References:

Jayne D, et al. JAMA. 2017;doi:10.1001/jama.2017.7219.

Jeong IG, et al. JAMA. 2017;doi:10.1001/jama.2017.14586.

Wright JD. JAMA. 2017;doi:10.1001/jama.2017.13696.

For more information:

In Gab Jeong, MD, PhD, can be reached at Department of Urology, Asan Medical Center, Univeristy of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea; email: igjeong@amc.seoul.kr.

Disclosures: Jayne reports a proctor role with Intuitive Surgical Inc. Please see the full study for a list of all other authors’ relevant financial disclosures. Jeong reports no relevant financial disclosures. One author reports personal fees from Intuitive Surgical. Wright reports consultant roles with Clovis Oncology and Tesaro.