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.


Journal

JAMA network open
ISSN: 2574-3805
Titre abrégé: JAMA Netw Open
Pays: United States
ID NLM: 101729235

Informations de publication

Date de publication:
01 02 2022
Historique:
entrez: 16 2 2022
pubmed: 17 2 2022
medline: 3 3 2022
Statut: epublish

Résumé

No data exist on time to recovery of patient-reported and performance-related measures of functional independence after radical cystectomy (open or robotic). To determine recovery of functional independence after radical cystectomy and whether robot-assisted radical cystectomy (RARC) is associated with any advantage over open procedures. 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. Robot-assisted radical cystectomy or open radical cystectomy (ORC). 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. 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. 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. ClinicalTrials.gov Identifier: NCT01157676.

Identifiants

pubmed: 35171260
pii: 2789083
doi: 10.1001/jamanetworkopen.2021.48329
pmc: PMC8851298
doi:

Banques de données

ClinicalTrials.gov
['NCT01157676']

Types de publication

Comparative Study Journal Article Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

e2148329

Subventions

Organisme : NCI NIH HHS
ID : R01 CA155388
Pays : United States

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Auteurs

Vivek Venkatramani (V)

Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.
Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida.

Isildinha M Reis (IM)

Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida.

Mark L Gonzalgo (ML)

Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.
Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida.

Erik P Castle (EP)

Department of Urology, Tulane University School of Medicine, New Orleans, Louisiana.

Michael E Woods (ME)

Department of Urology, University of North Carolina at Chapel Hill.

Robert S Svatek (RS)

Department of Urology, Division of Urologic Oncology, University of Texas Health Science Center at San Antonio.

Alon Z Weizer (AZ)

Department of Urology, University of Michigan, Ann Arbor.

Badrinath R Konety (BR)

Department of Urology, University of Minnesota, Minneapolis.

Mathew Tollefson (M)

Department of Urology, Mayo Clinic, Rochester, Minnesota.

Tracey L Krupski (TL)

Department of Urology, University of Virginia Health Science Center, Charlottesville.

Norm D Smith (ND)

Department of Urology, North Shore University Health System, Evanston, Illinois.

Ahmad Shabsigh (A)

Department of Urology, Ohio State University, Columbus.

Daniel A Barocas (DA)

Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee.

Marcus L Quek (ML)

Department of Urology, Loyola University Medical Center, Maywood, Illinois.

Atreya Dash (A)

Department of Urology, University of Washington, Seattle.

Dipen J Parekh (DJ)

Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.
Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida.

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Classifications MeSH