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result(s) for
"Ingrosso Manuela"
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Safety of on- vs off-clamp robotic partial nephrectomy: per-protocol analysis from the data of the CLOCK randomized trial
2020
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.
Journal Article
The role of warm ischemia time on functional outcomes after robotic partial nephrectomy: a radionuclide renal scan study from the clock randomized trial
by
Veccia, Alessandro
,
De Concilio, Bernardino
,
Porreca, Angelo
in
Creatinine
,
Epidermal growth factor receptors
,
Ischemia
2023
PurposeTo evaluate the relationship between warm ischemia time (WIT) duration and renal function after robot-assisted partial nephrectomy (RAPN).MethodsThe CLOCK trial is a phase 3 randomized controlled trial comparing on- vs off-clamp RAPN. All patients underwent pre- and postoperative renal scintigraphy. Six-month absolute variation of eGFR (AV-GFR), rate of relative variation in eGFR over 25% (RV-GFR > 25), absolute variation of split renal function (SRF) at scintigraphy (AV-SRF).The relationships WIT/outcomes were assessed by correlation graphs and then modeled by uni- and multivariable regression.Results324 patients were included (206 on-clamp, 118 off-clamp RAPN). Correlation graphs showed a threshold on WIT equal to 10 min. The differences in outcome measures between cases with WIT < vs ≥ 10 min were: AV-GFR − 3.7 vs − 7.5 ml/min (p < 0.001); AV-SRF − 1% vs − 3.6% (p < 0.001); RV-GFR > 25 9.3% vs 17.8% (p = 0.008). Multivariable models found that AV-GFR was related to WIT ≥ 10 min (regression coefficient [RC] − 0.52, p = 0.019), age (RC − 0.35, p = 0.001) and baseline eGFR (RC − 0.30, p < 0.001); RV-GFR > 25 to WIT ≥ 10 min (odds ratio [OR] 1.11, p = 0.007) and acute kidney injury defined as > 50% increase in serum creatinine (OR 19.7, p = 0.009); AV-SRF to WIT ≥ 10 min (RC − 0.30, p = 0.018), baseline SRF (RC − 0.76, p < 0.001) and RENAL score (RC − 0.60. p = 0.028).The main limitation was that the CLOCK trial was designed on a different endpoint and therefore the present analysis could be underpowered.ConclusionsUp to 10 min WIT had no consequences on functional outcomes. Above the 10-min threshold, a statistically significant, but clinically negligible impact was found.
Journal Article
Plankton Resting Stages in the Marine Sediments of the Bay of Vlorë (Albania)
In the frame of the INTERREG III CISM project, sediment cores were collected at 2 stations in the Gulf of Vlorë to study the plankton resting stage assemblages. A total of 87 morphotypes were identified and produced by Dinophyta, Ciliophora, Rotifera, and Crustacea. In 22 cases, the cyst belonged to a species absent from the plankton of the same period. The most abundant resting stages were those produced by Scrippsiella species (Dinophyta). Some calcareous cysts were identified as fossil species associated with Pleistocene to Pliocene sediment, although they were also found in surface sediments and some of them successfully germinated, thus proving their modern status. Total abundance generally decreased with sediment depth at station 40, while station 45 showed distinct maxima at 3 and 8 cm below the sediment surface. The depth of peak abundance in the sediment varied with species. This paper presents the first study of the plankton resting stages in the Bay of Vlorë. The study confirmed the utility of this type of investigation for a more correct evaluation of species diversity. In addition, the varying distribution with sediment depth suggests that this field could be of some importance in determining the history of species assemblages.
Journal Article
Zidovudine and thymus humoral factor gamma-2 in the treatment of HIV infection: Preliminary clinical experience
by
Taras, A.
,
Suter, F.
,
Grazia Pravettoni, Maria
in
Adult
,
Anti-HIV Agents - therapeutic use
,
Biological and medical sciences
1997
A case-control, prospective, open-label, clinical trial to evaluate efficacy and safety of a combined zidovudine/Thymus Humoral Factor Gamma-2 (THF) therapy in HIV-infected subjects was conducted in 13 patients. Twenty-six patients were included as controls receiving only zidovudine. The two groups of patients were matched according to sex, age, CDC stage of HIV infection, number of CD4+ T cells and type of previous opportunistic infections (if any) and all patients and controls were naive for antiretroviral therapy at the moment they entered the trial. The observation period was protracted up to 47 months (mean 28 +/- 13 months). No significant difference was observed between the two groups as far as surrogate markers of HIV disease progression are concerned. However, patients receiving zidovudine and THF showed a lower number of opportunistic complications. Only one patient in this group progressed to manifest AIDS while 9 of 18 controls presented disease progression. Four patients died in the case group, all of them were CDC stage IV at admission, and 15 of 26 died in the control group (all CDC stage IV at admission, and four patients who presented disease progression during the study period). Survival time was increased in the case group. The exact immunological effect of thymus hormones in HIV infection has still to be elucidated, but a possible therapeutic role of these agents is foreseeable.
Journal Article