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Perioperative outcomes and oncologic efficacy from a pilot prospective randomized clinical trial of open versus
Dipen J Parekh1, Jamie Messer, John Fitzgerald
1Department of Urology, University of Texas Health Sciences Center at San Antonio, San Antonio, Texas, USA. parekhd@med.miami.edu
Purpose:
Robotic assisted laparoscopic radical cystectomy for bladder cancer has been reported with potential for improvement in perioperative morbidity compared to the open approach. However, most studies are retrospective with significant selection bias.
Materials And Methods:
A pilot prospective randomized trial evaluating perioperative outcomes and oncologic efficacy of open vs robotic assisted laparoscopic radical cystectomy for consecutive patients was performed from July 2009 to June 2011.
Results:
To date 47 patients have been randomized with data available on 40 patients for analysis. Each group was similar with regard to age, gender, race, body mass index and comorbidities, as well as previous surgeries, operative time, postoperative complications and final pathological stage. We observed no significant differences between oncologic outcomes of positive margins (5% each, p = 0.50) or number of lymph nodes removed for open radical cystectomy (23, IQR 15-28) vs robotic assisted laparoscopic radical cystectomy (11, IQR 8.75-21.5) groups (p = 0.135). The robotic assisted laparoscopic radical cystectomy group (400 ml, IQR 300-762.5) was noted to have decreased estimated blood loss compared to the open radical cystectomy group (800 ml, IQR 400-1,100) and trended toward a decreased rate of excessive length of stay (greater than 5 days) (65% vs 90%, p = 0.11) compared to the open radical cystectomy group. The robotic group also trended toward fewer transfusions (40% vs 50%, p = 0.26).
Conclusions:
Our study validates the concept of randomizing patients with bladder cancer undergoing radical cystectomy to an open or robotic approach. Our results suggest no significant differences in surrogates of oncologic efficacy. Robotic assisted laparoscopic radical cystectomy demonstrates potential benefits of decreased estimated blood loss and decreased hospital stay compared to open radical cystectomy. Our results need to be validated in a larger multicenter prospective randomized clinical trial.