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Length of stay is shorter with the robotic procedure, but operative time is longer.
“Journal Article of the Month” is a new Urology Times section in which Badar M. Mian, MD (left), offers perspective on noteworthy research in the peer-reviewed literature. Dr. Mian is associate professor of surgery in the division of urology at Albany Medical College, Albany, NY.
The promise of robot-assisted surgery has been to potentially improve surgical outcomes of complex procedures and maintain cancer control while decreasing perioperative pain and complications, usually in the absence of high-level evidence.
According to recently published results of the Randomized Open versus Robotic Cystectomy (RAZOR) trial, robotic cystectomy was found to be “non-inferior,” yielding similar cancer progression-free survival as the open cystectomy technique (Lancet 2018; 391:2525-36). This is the first multicenter, phase III randomized trial comparing the outcomes of robot-assisted cystectomy with open cystectomy.
After the initial randomization of 350 patients, the investigators successfully completed robotic or open cystectomy in 150 and 152 patients, respectively (excluding those with unresectable or converted cases or consent withdrawal). Some patients (number not mentioned) who previously had open abdominal or pelvic surgery were excluded before randomization. Both open and robotic surgery was performed at each of the 15 participating U.S. centers, but the criteria for surgeon experience was quite minimal at 10 cases in the previous year (open or robotic).
Importantly, the urinary diversion was performed extracorporeally; ie, with an open incision. The type of urinary diversion and the use of neoadjuvant chemotherapy was at the discretion of the surgeon. In the robotic and open cystectomy groups, ileal neobladder was constructed in 24% and 20%, and neoadjuvant chemotherapy was used in 27% and 36%, respectively.
The primary endpoint was to demonstrate non-inferiority of the robotic approach for progression-free survival. The study design allowed for a non-inferiority margin of –15 percentage points; ie, if the survival difference was –12 percentage points for the robotic approach, it would still have met the criteria for non-inferiority. This 15-percentage point allowance given to robotic surgery was thought by the study designer to be a good tradeoff for the potential benefits such as less morbidity and shorter time to adjuvant chemotherapy.
Next: 2-year PFS similar in both groups2-year PFS similar in both groups
Two-year progression-free survival was 72.3% in the robotic cystectomy group and 71.6% in the open cystectomy group. The secondary endpoints favoring robotic surgery included lower blood loss and transfusion rate. Initial hospital length of stay was a bit shorter for robotic surgery (6 vs. 7 days). However, ER visits and readmission rates (other studies have reported >25%) are not mentioned.
The overall minor and major complication rate of robotic cystectomy (67%) was similar to that of open cystectomy (69%), except for a few differences. Urinary tract infections were more common in robotic cystectomy (35%) than open cystectomy (26%), but postoperative ileus was similar.
Despite performing the urinary diversion extracorporeally and excluding patients with previous abdominal or pelvic surgery, the median operative time was 67 minutes longer in the robotic cystectomy group. It’s not difficult to conceive a significant increase in the robotic operative time if those patients were to be included.
Radical cystectomy is a major, life-altering intervention, with significant morbidity. Thus, any attempts at incrementally improving outcomes are to be commended, especially in the setting of a randomized controlled trial. Individual urologists may interpret these results differently, but should this be considered a license to promote the use of the robotic approach for all cystectomies?
The main oncologic outcomes and complication rates in the robotic cystectomy group were similar or non-inferior to open surgery. Are the lower transfusion rate and shorter hospital stay by 1 day in the robotic group valid tradeoffs for the longer operative time and increased cost (direct and indirect)?
As the authors correctly point out, this trial underscores the need for further high-quality trials to assess the true benefits of this and other surgical innovations.