Evidence map›Paper›PMID 31342246›Full record

Trial reportWorld journal of urology2020

Safety of on- vs off-clamp robotic partial nephrectomy: per-protocol analysis from the data of the CLOCK randomized trial.

Alessandro Antonelli, Luca Cindolo, Marco Sandri, Riccardo Bertolo, Filippo Annino, Marco Carini, Antonio Celia, Carlo D'Orta, Bernardino De Concilio, Maria Furlan and 13 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in World journal of urology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02287987 (Prospective Randomized Trial Comparing Clamp Versus Clampless Robot Assisted Partial Nephrectomy), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
3.3field-weighted citation impact, top 7% 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.

NCT02287987 naunknown statusnot on this map

Prospective Randomized Trial Comparing Clamp Versus Clampless Robot Assisted Partial Nephrectomy

TypeinterventionalSponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaRan2014 to 2016Enrolled200ConditionsNephrectomy, Kidney Neoplasm, Glomerular Filtration RateArmsClamp Robotic partial nephrectomy, Clampless Robotic partial nephrectomy
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 55 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors at 8 institutions in 2 countries.

Alessandro AntonelliUrology Unit, ASST Spedali Civili Hospital and Department of Medical and Surgical Specialties, Radiological Science, and Public Health, University of Brescia, Brescia, Italy. alessandro_antonelli@me.com.
Luca CindoloUrology Unit, D'Annunzio Hospital, University of Chieti, Chieti, Italy.
Marco SandriData Methods and Systems Statistical Laboratory, University of Brescia, Brescia, Italy.
Riccardo BertoloUrology Unit, San Carlo di Nancy Hospital, Rome, Italy.
Filippo AnninoUrology Unit, San Donato Hospital, Arezzo, Italy.
Marco CariniUrology Unit, Careggi Hospital, University of Florence, Florence, Italy.
Antonio CeliaUrology Unit, San Bassiano Hospital, Bassano Del Grappa, Italy.
Carlo D'OrtaUrology Unit, D'Annunzio Hospital, University of Chieti, Chieti, Italy.
Bernardino De ConcilioUrology Unit, San Bassiano Hospital, Bassano Del Grappa, Italy.
Maria FurlanUrology Unit, ASST Spedali Civili Hospital and Department of Medical and Surgical Specialties, Radiological Science, and Public Health, University of Brescia, Brescia, Italy.
Valentina GiommoniUrology Unit, San Donato Hospital, Arezzo, Italy.
Manuela IngrossoUrology Unit, D'Annunzio Hospital, University of Chieti, Chieti, Italy.
Andrea MariUrology Unit, Careggi Hospital, University of Florence, Florence, Italy.
Gianluca MutoUrology Unit, Careggi Hospital, University of Florence, Florence, Italy.
Roberto NucciottiUrology Unit, Misericordia Hospital, Grosseto, Italy.
Angelo PorrecaUrology Unit, Policlinico of Abano, Abano Terme, Italy.
Giulia PrimiceriUrology Unit, D'Annunzio Hospital, University of Chieti, Chieti, Italy.
Luigi SchipsUrology Unit, D'Annunzio Hospital, University of Chieti, Chieti, Italy.
Francesco SessaUrology Unit, Careggi Hospital, University of Florence, Florence, Italy.
Claudio SimeoneUrology Unit, ASST Spedali Civili Hospital and Department of Medical and Surgical Specialties, Radiological Science, and Public Health, University of Brescia, Brescia, Italy.
Alessandro VecciaUrology Unit, ASST Spedali Civili Hospital and Department of Medical and Surgical Specialties, Radiological Science, and Public Health, University of Brescia, Brescia, Italy.
Andrea MinerviniUrology Unit, Careggi Hospital, University of Florence, Florence, Italy.
AGILE Group (Italian Group for Advanced Laparo-Endoscopic Surgery)
University of Chieti-Pescara · ITUniversity of Florence · ITOspedale San Bassiano · ITOspedale San Carlo · ITOspedale San Donato · ITUniversity of Brescia · ITOspedale Misericordia - Grosseto · ITPoliclinico Abano Terme · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo compare the safety of on- vs off-clamp robotic partial nephrectomy (RAPN).

methods302 patients with RENAL masses ≤ 10 were randomized to undergo on-clamp (150) vs off-clamp (152) RAPN (CLOCK trial-ClinicalTrials.gov NCT02287987) at seven institutions by one experienced surgeon per institution. Intra-operative data, complications, and positive surgical margins were compared.

resultsDue to a relevant rate of shift from the assigned treatment, the per-protocol analysis only was considered and the data from 129 on-clamp vs 91 off-clamp RAPNs analyzed. Tumor size (off-clamp vs on-clamp, 2.2 vs 3.0 cm, p < 0.001) and RENAL score (5 vs 6, p < 0.001) significantly differed. At univariate analysis, no differences were found regarding intra-operative estimated blood loss (off- vs on-clamp, 100 vs 100 ml, p = 0.7), post-operative complications rate (19% vs 26%, p = 0.2), post-operative anemia (Hb decrease > 2.5 g/dl 26% vs 27%, p = 0.9; transfusion rate 3.4% vs 6.3%, p = 0.5; re-intervention due to bleeding 1.1% vs 4%, p = 0.4), acute kidney injury (4% vs 6%, p = 0.8), and positive surgical margins (3.5% vs 8.2%, p = 0.1). At multivariate analysis accounting for tumor diameter and complexity, considering the on-clamp group as the reference category, a significant difference was noted in the off-clamp group exclusively for blood loss (OR 0.3, 95% CI 0.09-0.52, p = 0.008).

conclusionsThe on-clamp and off-clamp approaches for RAPN showed a comparable safety profile.

Indexed as

AgedConstrictionFemaleHumansKidney NeoplasmsMaleMiddle AgedNephrectomyProspective StudiesRobotic Surgical ProceduresClampingClamplessOff-clampOn-clampPartial nephrectomyRobot

Identifiers

PMID31342246
OpenAlexW2963886807

What OpenQuestion holds

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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.