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A prospective randomized pilot study evaluating an ERAS protocol versus a standard protocol for patients treated with radical cystectomy and urinary diversion for bladder cancer

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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.

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Author information

Authors and Affiliations

Authors

Contributions

SKF: protocol/project development, data collection or management, data analysis, and manuscript writing/editing. JA: protocol/project development, data collection, or management. PB, WS, CC-M, and MG: manuscript writing/editing. RB: data analysis and manuscript writing/editing. AIS: protocol/project development, data analysis, and manuscript writing/editing

Corresponding author

Correspondence to Alan I. So.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Statement of human rights and informed consent

Written consent was acquired from all participants of the study. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary material 1 (EPS 219 kb) Figure S1: Study design

345_2017_2109_MOESM2_ESM.pdf

Supplementary material 2 (PDF 356 kb) Figure S2A: Mean visual pain score of patients following ERAS protocol in comparison with patients following standard protocol. Figure S2B: Number of patients following ERAS protocol experiencing nausea in comparison with patients following standard protocol

Supplementary material 3 (DOCX 84 kb) Table S1: Charlson Comorbidity Index for each patients included in the trial

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Frees, S.K., Aning, J., Black, P. et al. A prospective randomized pilot study evaluating an ERAS protocol versus a standard protocol for patients treated with radical cystectomy and urinary diversion for bladder cancer. World J Urol 36, 215–220 (2018). https://doi.org/10.1007/s00345-017-2109-2

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  • DOI: https://doi.org/10.1007/s00345-017-2109-2

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