Is a Drain Needed after Robotic Radical Prostatectomy with or without Pelvic Lymph Node Dissection? Results of a Single-Center Randomized Clinical Trial

Objective: To investigate by means of a randomized clinical trial the safety of no drain in the pelvic cavity after robot-assisted radical prostatectomy (RARP) with or without extended pelvic lymph node dissection (ePLND). Materials and Methods: From May to December 2016, 112 consecutive patients who underwent RARP with or without ePLND were prospectively randomized into a control group (CG) and study group (SG). In the CG, a drain was placed in the pelvic cavity at the end of surgery and removed after 24 hours. The trial was designed to assess noninferiority. The primary endpoint was evaluated as complication rates graded by the Clavien-Dindo score (CDS). Secondary endpoints included length of hospital stay (LOHS) and hospital readmission (RAD). Results and Limitations: At final analysis, 56 patients were in the CG and 54 belonged to the SG. The groups were homogenous for all preoperative and perioperative variables and did not show any difference in CDS complication rates (28.9% in the CG and 20.4% in the SG; p = 0.254), LOHS (on average 4 days in each group; p = 0.689), and RAD rates (3.6% in the CG and 3.7% in the SG; p = 0.970). Conclusions: In a modern cohort of patients who underwent RARP with or without ePLND, a single-center randomized controlled trial showed that no-drain policy is equivalent to drain after RARP in terms of CDS complication rate, LOHS, and RAD rate. The option of placing a postoperative drain for the first 24 hours could be considered in cases of difficult urethrovesical anastomosis with uncertain watertightness.