Cargando…
Comparison of Robot-Assisted and Open Radical Cystectomy in Recovery of Patient-Reported and Performance-Related Measures of Independence: A Secondary Analysis of a Randomized Clinical Trial
IMPORTANCE: No data exist on time to recovery of patient-reported and performance-related measures of functional independence after radical cystectomy (open or robotic). OBJECTIVE: To determine recovery of functional independence after radical cystectomy and whether robot-assisted radical cystectomy...
Autores principales: | , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Medical Association
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8851298/ https://www.ncbi.nlm.nih.gov/pubmed/35171260 http://dx.doi.org/10.1001/jamanetworkopen.2021.48329 |
_version_ | 1784652793132351488 |
---|---|
author | Venkatramani, Vivek Reis, Isildinha M. Gonzalgo, Mark L. Castle, Erik P. Woods, Michael E. Svatek, Robert S. Weizer, Alon Z. Konety, Badrinath R. Tollefson, Mathew Krupski, Tracey L. Smith, Norm D. Shabsigh, Ahmad Barocas, Daniel A. Quek, Marcus L. Dash, Atreya Parekh, Dipen J. |
author_facet | Venkatramani, Vivek Reis, Isildinha M. Gonzalgo, Mark L. Castle, Erik P. Woods, Michael E. Svatek, Robert S. Weizer, Alon Z. Konety, Badrinath R. Tollefson, Mathew Krupski, Tracey L. Smith, Norm D. Shabsigh, Ahmad Barocas, Daniel A. Quek, Marcus L. Dash, Atreya Parekh, Dipen J. |
author_sort | Venkatramani, Vivek |
collection | PubMed |
description | IMPORTANCE: No data exist on time to recovery of patient-reported and performance-related measures of functional independence after radical cystectomy (open or robotic). OBJECTIVE: To determine recovery of functional independence after radical cystectomy and whether robot-assisted radical cystectomy (RARC) is associated with any advantage over open procedures. DESIGN, SETTING, AND PARTICIPANTS: Data for this secondary analysis from the RAZOR (Randomized Open vs Robotic Cystectomy) trial were used. RAZOR was a phase 3 multicenter noninferiority trial across 15 academic medical centers in the US from July 1, 2011, to November 18, 2014, with a median follow-up of 2 years. Participants included the per-protocol population (n = 302). Data were analyzed from February 1, 2017, to May 1, 2021. INTERVENTIONS: Robot-assisted radical cystectomy or open radical cystectomy (ORC). MAIN OUTCOMES AND MEASURES: Patient-reported (activities of daily living [ADL] and independent ADL [iADL]) and performance-related (hand grip strength [HGS] and Timed Up & Go walking test [TUGWT]) measures of independence were assessed. Patterns of postoperative recovery for the entire cohort and comparisons between RARC and ORC were performed. Exploratory analyses to assess measures of independence across diversion type and to determine whether baseline impairments were associated with 90-day complications or 1-year mortality were performed. FINDINGS: Of the 302 patients included in the analysis (254 men [84.1%]; mean [SD] age at consent, 68.0 [9.7] years), 150 underwent RARC and 152 underwent ORC. Baseline characteristics were similar in both groups. For the entire cohort, ADL, iADL, and TUGWT recovered to baseline by 3 postoperative months, whereas HGS recovered by 6 months. There was no difference between RARC and ORC for ADL, iADL, TUGWT, or HGS scores at any time. Activities of daily living recovered 1 month after RARC (mean estimated score, 7.7 [95% CI, 7.3-8.0]) vs 3 months after ORC (mean estimated score, 7.5 [95% CI, 7.2-7.8]). Hand grip strength recovered by 3 months after RARC (mean estimated HGS, 29.0 [95% CI, 26.3-31.7] kg) vs 6 months after ORC (mean estimated HGS, 31.2 [95% CI, 28.8-34.2] kg). In the RARC group, 32 of 90 patients (35.6%) showed a recovery in HGS at 3 months vs 32 of 88 (36.4%) in the ORC group (P = .91), indicating a rejection of the primary study hypothesis for HGS. Independent ADL and TUGWT recovered in 3 months for both approaches. Hand grip strength showed earlier recovery in patients undergoing continent urinary diversion (mean HGS at 3 months, 31.3 [95% CI, 27.7-34.8] vs 33.9 [95% CI, 30.5-37.3] at baseline; P = .09) than noncontinent urinary diversion (mean HGS at 6 months, 27.4 [95% CI, 24.9-30.0] vs 29.5 [95% CI, 27.2-31.9] kg at baseline; P = .02), with no differences in other parameters. Baseline impairments in any parameter were not associated with 90-day complications or 1-year mortality. CONCLUSIONS AND RELEVANCE: The results of this secondary analysis suggest that patients require 3 to 6 months to recover baseline levels after radical cystectomy irrespective of surgical approach. These data will be invaluable in patient counseling and preparation. Hand grip strength and ADL tended to recover to baseline earlier after RARC; however, there was no difference in the percentage of patients recovering when compared with ORC. Further study is needed to assess the clinical significance of these findings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01157676 |
format | Online Article Text |
id | pubmed-8851298 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | American Medical Association |
record_format | MEDLINE/PubMed |
spelling | pubmed-88512982022-02-18 Comparison of Robot-Assisted and Open Radical Cystectomy in Recovery of Patient-Reported and Performance-Related Measures of Independence: A Secondary Analysis of a Randomized Clinical Trial Venkatramani, Vivek Reis, Isildinha M. Gonzalgo, Mark L. Castle, Erik P. Woods, Michael E. Svatek, Robert S. Weizer, Alon Z. Konety, Badrinath R. Tollefson, Mathew Krupski, Tracey L. Smith, Norm D. Shabsigh, Ahmad Barocas, Daniel A. Quek, Marcus L. Dash, Atreya Parekh, Dipen J. JAMA Netw Open Original Investigation IMPORTANCE: No data exist on time to recovery of patient-reported and performance-related measures of functional independence after radical cystectomy (open or robotic). OBJECTIVE: To determine recovery of functional independence after radical cystectomy and whether robot-assisted radical cystectomy (RARC) is associated with any advantage over open procedures. DESIGN, SETTING, AND PARTICIPANTS: Data for this secondary analysis from the RAZOR (Randomized Open vs Robotic Cystectomy) trial were used. RAZOR was a phase 3 multicenter noninferiority trial across 15 academic medical centers in the US from July 1, 2011, to November 18, 2014, with a median follow-up of 2 years. Participants included the per-protocol population (n = 302). Data were analyzed from February 1, 2017, to May 1, 2021. INTERVENTIONS: Robot-assisted radical cystectomy or open radical cystectomy (ORC). MAIN OUTCOMES AND MEASURES: Patient-reported (activities of daily living [ADL] and independent ADL [iADL]) and performance-related (hand grip strength [HGS] and Timed Up & Go walking test [TUGWT]) measures of independence were assessed. Patterns of postoperative recovery for the entire cohort and comparisons between RARC and ORC were performed. Exploratory analyses to assess measures of independence across diversion type and to determine whether baseline impairments were associated with 90-day complications or 1-year mortality were performed. FINDINGS: Of the 302 patients included in the analysis (254 men [84.1%]; mean [SD] age at consent, 68.0 [9.7] years), 150 underwent RARC and 152 underwent ORC. Baseline characteristics were similar in both groups. For the entire cohort, ADL, iADL, and TUGWT recovered to baseline by 3 postoperative months, whereas HGS recovered by 6 months. There was no difference between RARC and ORC for ADL, iADL, TUGWT, or HGS scores at any time. Activities of daily living recovered 1 month after RARC (mean estimated score, 7.7 [95% CI, 7.3-8.0]) vs 3 months after ORC (mean estimated score, 7.5 [95% CI, 7.2-7.8]). Hand grip strength recovered by 3 months after RARC (mean estimated HGS, 29.0 [95% CI, 26.3-31.7] kg) vs 6 months after ORC (mean estimated HGS, 31.2 [95% CI, 28.8-34.2] kg). In the RARC group, 32 of 90 patients (35.6%) showed a recovery in HGS at 3 months vs 32 of 88 (36.4%) in the ORC group (P = .91), indicating a rejection of the primary study hypothesis for HGS. Independent ADL and TUGWT recovered in 3 months for both approaches. Hand grip strength showed earlier recovery in patients undergoing continent urinary diversion (mean HGS at 3 months, 31.3 [95% CI, 27.7-34.8] vs 33.9 [95% CI, 30.5-37.3] at baseline; P = .09) than noncontinent urinary diversion (mean HGS at 6 months, 27.4 [95% CI, 24.9-30.0] vs 29.5 [95% CI, 27.2-31.9] kg at baseline; P = .02), with no differences in other parameters. Baseline impairments in any parameter were not associated with 90-day complications or 1-year mortality. CONCLUSIONS AND RELEVANCE: The results of this secondary analysis suggest that patients require 3 to 6 months to recover baseline levels after radical cystectomy irrespective of surgical approach. These data will be invaluable in patient counseling and preparation. Hand grip strength and ADL tended to recover to baseline earlier after RARC; however, there was no difference in the percentage of patients recovering when compared with ORC. Further study is needed to assess the clinical significance of these findings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01157676 American Medical Association 2022-02-16 /pmc/articles/PMC8851298/ /pubmed/35171260 http://dx.doi.org/10.1001/jamanetworkopen.2021.48329 Text en Copyright 2022 Venkatramani V et al. JAMA Network Open. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the CC-BY License. |
spellingShingle | Original Investigation Venkatramani, Vivek Reis, Isildinha M. Gonzalgo, Mark L. Castle, Erik P. Woods, Michael E. Svatek, Robert S. Weizer, Alon Z. Konety, Badrinath R. Tollefson, Mathew Krupski, Tracey L. Smith, Norm D. Shabsigh, Ahmad Barocas, Daniel A. Quek, Marcus L. Dash, Atreya Parekh, Dipen J. Comparison of Robot-Assisted and Open Radical Cystectomy in Recovery of Patient-Reported and Performance-Related Measures of Independence: A Secondary Analysis of a Randomized Clinical Trial |
title | Comparison of Robot-Assisted and Open Radical Cystectomy in Recovery of Patient-Reported and Performance-Related Measures of Independence: A Secondary Analysis of a Randomized Clinical Trial |
title_full | Comparison of Robot-Assisted and Open Radical Cystectomy in Recovery of Patient-Reported and Performance-Related Measures of Independence: A Secondary Analysis of a Randomized Clinical Trial |
title_fullStr | Comparison of Robot-Assisted and Open Radical Cystectomy in Recovery of Patient-Reported and Performance-Related Measures of Independence: A Secondary Analysis of a Randomized Clinical Trial |
title_full_unstemmed | Comparison of Robot-Assisted and Open Radical Cystectomy in Recovery of Patient-Reported and Performance-Related Measures of Independence: A Secondary Analysis of a Randomized Clinical Trial |
title_short | Comparison of Robot-Assisted and Open Radical Cystectomy in Recovery of Patient-Reported and Performance-Related Measures of Independence: A Secondary Analysis of a Randomized Clinical Trial |
title_sort | comparison of robot-assisted and open radical cystectomy in recovery of patient-reported and performance-related measures of independence: a secondary analysis of a randomized clinical trial |
topic | Original Investigation |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8851298/ https://www.ncbi.nlm.nih.gov/pubmed/35171260 http://dx.doi.org/10.1001/jamanetworkopen.2021.48329 |
work_keys_str_mv | AT venkatramanivivek comparisonofrobotassistedandopenradicalcystectomyinrecoveryofpatientreportedandperformancerelatedmeasuresofindependenceasecondaryanalysisofarandomizedclinicaltrial AT reisisildinham comparisonofrobotassistedandopenradicalcystectomyinrecoveryofpatientreportedandperformancerelatedmeasuresofindependenceasecondaryanalysisofarandomizedclinicaltrial AT gonzalgomarkl comparisonofrobotassistedandopenradicalcystectomyinrecoveryofpatientreportedandperformancerelatedmeasuresofindependenceasecondaryanalysisofarandomizedclinicaltrial AT castleerikp comparisonofrobotassistedandopenradicalcystectomyinrecoveryofpatientreportedandperformancerelatedmeasuresofindependenceasecondaryanalysisofarandomizedclinicaltrial AT woodsmichaele comparisonofrobotassistedandopenradicalcystectomyinrecoveryofpatientreportedandperformancerelatedmeasuresofindependenceasecondaryanalysisofarandomizedclinicaltrial AT svatekroberts comparisonofrobotassistedandopenradicalcystectomyinrecoveryofpatientreportedandperformancerelatedmeasuresofindependenceasecondaryanalysisofarandomizedclinicaltrial AT weizeralonz comparisonofrobotassistedandopenradicalcystectomyinrecoveryofpatientreportedandperformancerelatedmeasuresofindependenceasecondaryanalysisofarandomizedclinicaltrial AT konetybadrinathr comparisonofrobotassistedandopenradicalcystectomyinrecoveryofpatientreportedandperformancerelatedmeasuresofindependenceasecondaryanalysisofarandomizedclinicaltrial AT tollefsonmathew comparisonofrobotassistedandopenradicalcystectomyinrecoveryofpatientreportedandperformancerelatedmeasuresofindependenceasecondaryanalysisofarandomizedclinicaltrial AT krupskitraceyl comparisonofrobotassistedandopenradicalcystectomyinrecoveryofpatientreportedandperformancerelatedmeasuresofindependenceasecondaryanalysisofarandomizedclinicaltrial AT smithnormd comparisonofrobotassistedandopenradicalcystectomyinrecoveryofpatientreportedandperformancerelatedmeasuresofindependenceasecondaryanalysisofarandomizedclinicaltrial AT shabsighahmad comparisonofrobotassistedandopenradicalcystectomyinrecoveryofpatientreportedandperformancerelatedmeasuresofindependenceasecondaryanalysisofarandomizedclinicaltrial AT barocasdaniela comparisonofrobotassistedandopenradicalcystectomyinrecoveryofpatientreportedandperformancerelatedmeasuresofindependenceasecondaryanalysisofarandomizedclinicaltrial AT quekmarcusl comparisonofrobotassistedandopenradicalcystectomyinrecoveryofpatientreportedandperformancerelatedmeasuresofindependenceasecondaryanalysisofarandomizedclinicaltrial AT dashatreya comparisonofrobotassistedandopenradicalcystectomyinrecoveryofpatientreportedandperformancerelatedmeasuresofindependenceasecondaryanalysisofarandomizedclinicaltrial AT parekhdipenj comparisonofrobotassistedandopenradicalcystectomyinrecoveryofpatientreportedandperformancerelatedmeasuresofindependenceasecondaryanalysisofarandomizedclinicaltrial |