title: Perioperative outcomes and oncologic efficacy from a pilot prospective randomized clinical trial of open versus robotic assisted radical cystectomy.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Department of Urology, University of Texas Health Sciences Center at San Antonio, San Antonio, Texas, USA. parekhd@med.miami.edu
authors.forename: Dipen J
authors.initials: DJ
authors.lastname: Parekh
authors.forename: Jamie
authors.initials: J
authors.lastname: Messer
authors.forename: John
authors.initials: J
authors.lastname: Fitzgerald
authors.forename: Barbara
authors.initials: B
authors.lastname: Ercole
authors.forename: Robert
authors.initials: R
authors.lastname: Svatek
mesh_terms: D000368:Aged; D015653:Cystectomy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D012371:Robotics; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000601:surgery*