Sebastian Karl Frees1, Jonathan Aning1, Peter Black1, Werner Struss1, Robert Bell1, Claudia Chavez-Munoz1, Martin Gleave1, Alan I So2,3. 1. Department of Urologic Sciences, Vancouver Prostate Centre, University of British Columbia, Vancouver, Canada. 2. Department of Urologic Sciences, Vancouver Prostate Centre, University of British Columbia, Vancouver, Canada. dralanso@mail.ubc.ca. 3. Dept. of Urologic Sciences, UBC, Gordon and Leslie Diamond Health Care Centre, 2775 Laurel St. 6th floor, Vancouver, BC, V5Z1M9, Canada. dralanso@mail.ubc.ca.
Abstract
PURPOSE: There is a lack of evidence demonstrating the benefits of using enhanced recovery after surgery protocols (ERAS). Here, we propose to use a randomized clinical pilot study to demonstrate the benefits and feasibility of implementing ERAS versus standard protocols (SP) in patients undergoing radical cystectomy (RC) and urinary diversion. METHODS:27 consecutive patients undergoing RC were included in the study. 12 patients were prospectively randomized to follow an ERAS protocol and 15 patients followed an SP. Duration of hospital stay, time to first flatulence and bowel movement, complications and 30 day readmission rates, as well as subjective outcomes such as postoperative pain, nausea, bowel symptoms, quality of life (QoL), and patient experience and satisfaction were evaluated. RESULTS: Patients following ERAS had a significantly shorter: hospital stay, time to flatulence, and time to bowel movement than patients following SP. No major complications were reported. Only one patient in the ERAS group was readmitted for bowel obstruction, and no patients were readmitted in the SP group. Patients under ERAS reported lower postoperative pain scores. Mean Functional Assessment of Cancer Therapy Bladder Cancer score decreased and mean Expanded Prostate Cancer Index Composite, bowel symptom score increased in the SP group at the time of discharge compared to prior to surgery. CONCLUSIONS: This study shows the feasibility of a randomized pilot study assessing ERAS compared to SP post RC. ERAS protocol provided evidence of significant benefits over SP with similar complication rates. This study suggests the need for a clinical trial of assessing ERAS protocols after RC.
RCT Entities:
PURPOSE: There is a lack of evidence demonstrating the benefits of using enhanced recovery after surgery protocols (ERAS). Here, we propose to use a randomized clinical pilot study to demonstrate the benefits and feasibility of implementing ERAS versus standard protocols (SP) in patients undergoing radical cystectomy (RC) and urinary diversion. METHODS: 27 consecutive patients undergoing RC were included in the study. 12 patients were prospectively randomized to follow an ERAS protocol and 15 patients followed an SP. Duration of hospital stay, time to first flatulence and bowel movement, complications and 30 day readmission rates, as well as subjective outcomes such as postoperative pain, nausea, bowel symptoms, quality of life (QoL), and patient experience and satisfaction were evaluated. RESULTS:Patients following ERAS had a significantly shorter: hospital stay, time to flatulence, and time to bowel movement than patients following SP. No major complications were reported. Only one patient in the ERAS group was readmitted for bowel obstruction, and no patients were readmitted in the SP group. Patients under ERAS reported lower postoperative pain scores. Mean Functional Assessment of Cancer Therapy Bladder Cancer score decreased and mean Expanded Prostate Cancer Index Composite, bowel symptom score increased in the SP group at the time of discharge compared to prior to surgery. CONCLUSIONS: This study shows the feasibility of a randomized pilot study assessing ERAS compared to SP post RC. ERAS protocol provided evidence of significant benefits over SP with similar complication rates. This study suggests the need for a clinical trial of assessing ERAS protocols after RC.
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