Evidence map›Paper›PMID 34986007›Full record

Trial reportThe Journal of urology2022

Open Radical Cystectomy versus Robot-Assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Early Outcomes of a Single-Center Randomized Controlled Trial.

Riccardo Mastroianni, Mariaconsiglia Ferriero, Gabriele Tuderti, Umberto Anceschi, Alfredo Maria Bove, Aldo Brassetti, Leonardo Misuraca, Ashanti Zampa, Giulia Torregiani, Edoardo Ghiani and 4 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in The Journal of urology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05891535 (Stentless Florence Robotic Intracorporeal Neobladder), which is not on this map. Cited by 64 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 6 pooled it
25.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05891535 naunknown statusnot on this map

Stentless Florence Robotic Intracorporeal Neobladder (FloRIN)

TypeinterventionalSponsorUniversity of FlorenceRan2021 to 2024Enrolled63ConditionsPerioperative ComplicationArmsRobot assisted radical cystectomy without mono J ureteral stent placement, Robot assisted radical cystectomy with mono J ureteral stent placement
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 6 syntheses or guidelines pooled it, 122 citations in OpenAlex.

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4 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 1 institution in 1 country.

Riccardo MastroianniIRCCS "Regina Elena" National Cancer Institute, Department of Urology, Rome, Italy.ORCID 0000-0003-3708-2209
Mariaconsiglia FerrieroIRCCS "Regina Elena" National Cancer Institute, Department of Urology, Rome, Italy.
Gabriele TudertiIRCCS "Regina Elena" National Cancer Institute, Department of Urology, Rome, Italy.
Umberto AnceschiIRCCS "Regina Elena" National Cancer Institute, Department of Urology, Rome, Italy.
Alfredo Maria BoveIRCCS "Regina Elena" National Cancer Institute, Department of Urology, Rome, Italy.
Aldo BrassettiIRCCS "Regina Elena" National Cancer Institute, Department of Urology, Rome, Italy.
Leonardo MisuracaIRCCS "Regina Elena" National Cancer Institute, Department of Urology, Rome, Italy.
Ashanti ZampaIRCCS "Regina Elena" National Cancer Institute, Department of Clinical Trial Centre, Biostatistics and Bioinformatics, Rome, Italy.
Giulia TorregianiIRCCS "Regina Elena" National Cancer Institute, Department of Urology, Rome, Italy.
Edoardo GhianiIRCCS "Regina Elena" National Cancer Institute, Department of Urology, Rome, Italy.
Diana GiannarelliIRCCS "Regina Elena" National Cancer Institute, Department of Clinical Trial Centre, Biostatistics and Bioinformatics, Rome, Italy.
Salvatore GuaglianoneIRCCS "Regina Elena" National Cancer Institute, Department of Urology, Rome, Italy.
Michele GallucciIRCCS "Regina Elena" National Cancer Institute, Department of Urology, Rome, Italy.
Giuseppe SimoneIRCCS "Regina Elena" National Cancer Institute, Department of Urology, Rome, Italy.
Istituti di Ricovero e Cura a Carattere Scientifico · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeRadical cystectomy (RC) with urinary diversion (UD) is still considered a complex surgery associated with significant morbidity. Open RC (ORC) remains the reference option of treatment, even if adoption of robot-assisted RC (RARC) is rapidly increasing. To date, all the available randomized controlled trials were characterized by an extracorporeal approach in performing UD, undermining potential benefits of a totally minimally invasive procedure. In this study, we aimed to report perioperative and 6-month outcomes from the first RCT comparing ORC and RARC with totally intracorporeal UD. MATERIALS AND

methodsPatients were eligible for randomization if they had a diagnostic transurethral resection of bladder tumor with cT2-4, cN0, cM0 or recurrent high-grade nonmuscle-invasive bladder cancer and no anesthesiological contraindications to robotic surgery. Patients were enrolled with a covariate adaptive randomization process based on the following variables: body mass index, American Society of Anesthesiologists® score, baseline hemoglobin, planned UD, neoadjuvant chemotherapy and cT stage. The primary end point was to demonstrate the superiority of RARC with intracorporeal UD in terms of a 50% transfusion rate reduction.

resultsOverall, 116 consecutive patients (58 RARC, 58 ORC) were enrolled. Among primary endpoint, overall perioperative transfusion rates were significantly lower in the RARC cohort (RARC: 22% vs ORC: 41%; p=0.046).

conclusionsThis prospective randomized trial observed 22% and 41% overall perioperative transfusion rates in patients treated by RARC and ORC, respectively, confirming a significant benefit in favor of RARC with intracorporeal UD. However, perioperative complications, hospital stay and 6-month health-related quality of life were largely comparable between groups. Oncologic and functional outcomes will be assessed at longer followup to observe potential differences between arms.

Indexed as

RoboticsRobotic Surgical ProceduresUrinary Bladder NeoplasmsUrinary DiversionCystectomyHumansNeoplasm Recurrence, LocalPostoperative ComplicationsProspective StudiesQuality of LifeTreatment Outcomecystectomyrandomized controlled trialrobotic surgical proceduresurinary bladder neoplasms

Identifiers

PMID34986007
PMCPMC12721634
OpenAlexW4206101132

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.