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Prospective, randomized trial comparing surgical, functional and oncological outcomes between clamp and clamp-less robot assisted partial nephrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clamp | Active Comparator | Laparoscopic robot-assisted partial nephrectomy with clamping the renal pedicle during the resection of the tumor |
|
| Off clamp | Experimental | Laparoscopic robot-assisted partial nephrectomy without clamping the renal pedicle during the resection of the tumor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clamp Robotic partial nephrectomy | Procedure | Renal artery clamping during partial nephrectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular Filtration Rate (GFR) variation | difference between pre and post operative Glomerular Filtration Rate (GFR) | 3-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of clampless robotic partial nephrectomy | number of cases shifted from clampless to clamping procedure; time of suture of the renal parenchyma; overall operative time. | Duration of the surgical procedure |
| Morbidity of clampless robotic partial nephrectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandro Antonelli, Doctor | Spedali Civili di Brescia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Department of Urology, university Hospital Spedali Civili di Brescia | Brescia | 25123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20825756 | Background | Thompson RH, Lane BR, Lohse CM, Leibovich BC, Fergany A, Frank I, Gill IS, Blute ML, Campbell SC. Every minute counts when the renal hilum is clamped during partial nephrectomy. Eur Urol. 2010 Sep;58(3):340-5. doi: 10.1016/j.eururo.2010.05.047. Epub 2010 Jun 9. | |
| 24219227 | Background | Ficarra V, Minervini A, Antonelli A, Bhayani S, Guazzoni G, Longo N, Martorana G, Morgia G, Mottrie A, Porter J, Simeone C, Vittori G, Zattoni F, Carini M. A multicentre matched-pair analysis comparing robot-assisted versus open partial nephrectomy. BJU Int. 2014 Jun;113(6):936-41. doi: 10.1111/bju.12570. Epub 2014 May 22. |
| Label | URL |
|---|---|
| EAU guidelines 2014 | View source |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Clampless Robotic partial nephrectomy |
| Procedure |
Robotic partial nephrectomy without renal artery clamping |
|
Estimated blood loss; pre/post operative variation of hemoglobin value; overall complications rate; bleeding complications rate |
| 90 days |
| Oncological safety of clampless robotic partial nephrectomy | positive surgical margins rate | 15 days |
| 24013181 | Background | Minervini A, Siena G, Antonelli A, Bianchi G, Bocciardi AM, Cosciani Cunico S, Ficarra V, Fiori C, Fusco F, Mari A, Martorana G, Medica M, Mirone V, Morgia G, Porpiglia F, Rocco F, Rovereto B, Schiavina R, Simeone C, Terrone C, Volpe A, Carini M, Serni S; Members of the RECORd Project-LUNA Foundation. Open versus laparoscopic partial nephrectomy for clinical T1a renal masses: a matched-pair comparison of 280 patients with TRIFECTA outcomes (RECORd Project). World J Urol. 2014 Feb;32(1):257-63. doi: 10.1007/s00345-013-1155-7. Epub 2013 Sep 7. |
| 17998077 | Background | Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007 Dec;60(12):1234-8. doi: 10.1016/j.jclinepi.2007.02.006. Epub 2007 Jun 6. |
| 23122834 | Background | Kaczmarek BF, Tanagho YS, Hillyer SP, Mullins JK, Diaz M, Trinh QD, Bhayani SB, Allaf ME, Stifelman MD, Kaouk JH, Rogers CG. Off-clamp robot-assisted partial nephrectomy preserves renal function: a multi-institutional propensity score analysis. Eur Urol. 2013 Dec;64(6):988-93. doi: 10.1016/j.eururo.2012.10.009. Epub 2012 Oct 16. |
| 19616235 | Background | Kutikov A, Uzzo RG. The R.E.N.A.L. nephrometry score: a comprehensive standardized system for quantitating renal tumor size, location and depth. J Urol. 2009 Sep;182(3):844-53. doi: 10.1016/j.juro.2009.05.035. Epub 2009 Jul 17. |
| 24954792 | Background | Minervini A, Carini M, Uzzo RG, Campi R, Smaldone MC, Kutikov A. Standardized reporting of resection technique during nephron-sparing surgery: the surface-intermediate-base margin score. Eur Urol. 2014 Nov;66(5):803-5. doi: 10.1016/j.eururo.2014.06.002. Epub 2014 Jun 18. |
| 38245480 | Derived | Bertolo R, Antonelli A, Minervini A, Campi R. Off-clamp Versus On-clamp Partial Nephrectomy: Re-envision of a Dilemma. Eur Urol Oncol. 2024 Apr;7(2):173-176. doi: 10.1016/j.euo.2023.12.009. Epub 2024 Jan 19. |
| 36506251 | Derived | Bertolo R, Bove P, Sandri M, Celia A, Cindolo L, Cipriani C, Falsaperla M, Leonardo C, Mari A, Parma P, Veccia A, Veneziano D, Minervini A, Antonelli A; AGILE Group (Italian Group for Advanced Laparoendoscopic Surgery). Randomized Clinical Trial Comparing On-clamp Versus Off-clamp Laparoscopic Partial Nephrectomy for Small Renal Masses (CLOCK II Laparoscopic Study): A Intention-to-treat Analysis of Perioperative Outcomes. Eur Urol Open Sci. 2022 Oct 28;46:75-81. doi: 10.1016/j.euros.2022.10.007. eCollection 2022 Dec. |
| 31342246 | Derived | Antonelli A, Cindolo L, Sandri M, Bertolo R, Annino F, Carini M, Celia A, D'Orta C, De Concilio B, Furlan M, Giommoni V, Ingrosso M, Mari A, Muto G, Nucciotti R, Porreca A, Primiceri G, Schips L, Sessa F, Simeone C, Veccia A, Minervini A; AGILE Group (Italian Group for Advanced Laparo-Endoscopic Surgery). Safety of on- vs off-clamp robotic partial nephrectomy: per-protocol analysis from the data of the CLOCK randomized trial. World J Urol. 2020 May;38(5):1101-1108. doi: 10.1007/s00345-019-02879-4. Epub 2019 Jul 24. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |