Abstract
The present study seeks to present a single-blind, randomized control trial of a hypothermic anti-inflammatory device, the endorectal cooling balloon (ECB), to assess whether regional hypothermia could improve 90-day and time to pad-free continence following robot-assisted radical prostatectomy (RARP). Five high-volume surgeons at three institutions had patients randomized (1:1) to regional hypothermia with ECB versus control. Patients were blinded to device use, as it was inserted and removed intraoperatively. Knowledge of device use was restricted to the operating room personnel only; recovery room and ward nursing staff were not informed of device use and instructed to indicate such if a patient inquired. An independent and blinded data acquisition contractor assessed outcomes via components of the EPIC and IPSS. The primary outcome was categorical pad-free continence at 90-days and the secondary outcome was a Kaplan-Meier time-to pad-free continence at 90 days. 100 hypothermia and 99 control patients were included. The primary outcome of 90-day pad-free continence was 50.0% (27.8–70.0%) in the hypothermia group versus 59.2% (33.3–78.6%) in the control (p = 0.194). The secondary outcome of Kaplan Meier analysis for time to 90-day continence was not statistically significant. At one year, there were also no statistically significant differences in continence recovery. Post-hoc analysis revealed a trend towards improvement in continence in one of three sites. Overall, the trial demonstrated no benefit to regional hypothermia either in our primary or secondary outcomes. It is suggested that surgical technique and prevention of surgical trauma may be more advantageous to improving continence recovery.
Highlights
As individual surgeon technique and operative time are not shown to vary due to age
We conducted a randomized, single-blinded, controlled trial to assess whether regional hypothermia with the endorectal cooling balloon (ECB) device during robot-assisted radical prostatectomy (RARP) could improve time to and overall urinary continence
Of the 199 patients who were recruited for the trial, 99 and 100 were randomized to the control and hypothermia groups, respectively. 100% of these patients completed pre- and postoperative interviews, received the intended treatment, and were analyzed for the primary and secondary outcome (Fig. 2)
Summary
As individual surgeon technique and operative time are not shown to vary due to age. In 2009, our group developed and patented technology of an endorectal cooling balloon (ECB) which circulates 4 degrees Celsius saline to provide regional hypothermia during RARP in an effort to reduce post-surgical inflammation (Fig. 1)[19]. Our single surgeon studies showed a significant reduction in time to continence (39 vs 62 days, p = 0.0003) in patients who received regional hypothermia and improved overall long-term continence at one year (94% vs 86%, P = < 0.001), in patients over the age of 704,20. We conducted a randomized, single-blinded, controlled trial to assess whether regional hypothermia with the ECB device during RARP could improve time to and overall urinary continence
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