Introduction

The prophylactic placement of a pelvic drain (PD) after prostatectomy has long been an empiric practice despite lack of high-level evidence of clinical benefit. However, with RARP and improvements to surgical technique, routine pelvic drainage may not be necessary in the contemporary setting. We sought to determine if eliminating the prophylactic placement of a PD after RARP affects incidence of early postoperative adverse events.

Methods

Prostate cancer patients scheduled to undergo RARP were randomized prospectively at the end of surgery in a double-blinded study to undergo PD placement or no PD placement. Patient with prior radiotherapy, prior extensive pelvic surgery and demonstrable intra-operative leakage upon bladder irrigation at the end of the procedure were excluded. Demographic data, preoperative and postoperative results for the two groups were compared. The primary endpoint was overall (Clavien I-V) incidence of complications, specifically to assess that 90-day complication rate in the no PD group was within 10% of the 90-day complication rate in the PD group, in a non-inferiority setting.

Results

From September 2012 to April 2016, 179 RARP patients were randomized into two groups: Group 1 did not receive a PD (n=85) while Group 2 did receive a PD (n=94). Between the two groups, no difference was observed in baseline characteristics such as age, body mass index, race, and ethnicity. Patients in group 1 and 2 were comparable in median PSA (6.3 vs 5.8 respectively, p=0.5), clinical stage (p=0.4), D’Amico risk classification (p=0.4), median lymph nodes dissected (18 vs 18, p=0.4) and proportion of patients receiving an extended pelvic lymph node dissection (71.8% vs 78.7% respectively, p=0.5). The incidence of 90-day overall (Clavien I-V) complications in the no PD group (22.4%) was not inferior to the incidence of 90-day overall complications in the PD group (26.6%, p=0.015 for difference of proportions <10%). Similarly, the incidence of 90-day major (Clavien > III) complications in the no PD group (7.1%) was not inferior to the incidence of 90-day major complications in the PD group (4.3%, p=0.037 for difference of proportions <10%). The symptomatic lymphocele rates (1.2% in Group 1, 3.2% in Group 2) were comparable between the two arms (p=0.6).

Conclusions

The incidence of early postoperative overall and major adverse events in the no PD group was not inferior to the group who received a PD. In properly selected patients, the use of a PD after RARP can be safely withheld without significant additional morbidity. _x000D_ _x000D_

Funding

None