Perioperative Outcomes and Oncologic Efficacy from a Pilot Prospective Randomized Clinical Trial of Open versus Robotic Assisted Radical Cystectomy
Parekh DJ, Messer J, Fitzgerald J, Ercole B, Svatek R. J Urol. 2012 Sep 24. pii: S0022-5347(12)04957-9. doi: 10.1016/j.juro.2012.09.077. [Epub ahead of print]

Source

University of Texas Health Sciences Center at San Antonio, Department of Urology, 7703 Floyd Curl Drive, MS7845, San Antonio TX 78229-3900. Electronic address: parekhd@med.miami.edu.

Abstract

PURPOSE:

Robotic assisted Laparoscopic Radical Cystectomy (RARC) for bladder cancer has been reported with potential for improvement in perioperative morbidity compared to open approach. However, most studies are retrospective with significant selection bias.

METHODS:

A pilot prospective randomized trial evaluating perioperative outcomes and oncologic efficacy comparing ORC versus RARC 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 regards to age, sex, race, BMI, comorbidities, and previous surgeries, operative time, postoperative complications, and final pathologic stage. We observed no significant difference between oncologic outcomes of positive margins (5% each, p 0.50) or number of LN removed for the ORC (23, IQR 15-28) versus the RARC (11, IQR 8.75-21.5) groups respectively (p0.135). The RARC group (400 mL, IQR 300-762.5) was noted to have decreased EBL compared to the ORC group (800 mL, IQR 400-1100) and trended towards decreased rate of excessive LOS (>5 days) (65% vs. 90%, p 0.11) for the RARC versus ORC groups. The robotic group trended towards fewer transfusions (40% versus 50%, p 0.26).

CONCLUSIONS:

Our study validates the concept of randomizing patients with bladder cancer undergoing radical cystectomy to open or robotic approach. Our results suggest no significant differences in surrogates of oncologic efficacy. RARC demonstrates potential benefits of decreased EBL and decreased hospital stay compared to ORC. Our results need to be validated in a larger multicenter prospective randomized clinical trial.