CLOCK: CLamp vs Off Clamp Kidney During Partial Nephrectomy
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Other)
Overall Status
Unknown status
CT.gov ID
NCT02287987
Collaborator
(none)
200
1
2
24
8.3
Study Details
Study Description
Brief Summary
Prospective, randomized trial comparing surgical, functional and oncological outcomes between clamp and clamp-less robot assisted partial nephrectomy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Trial Comparing Clamp Versus Clampless Robot Assisted Partial Nephrectomy
Study Start Date
:
Oct 1, 2014
Anticipated Primary Completion Date
:
Oct 1, 2016
Anticipated Study Completion Date
:
Oct 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Clamp Laparoscopic robot-assisted partial nephrectomy with clamping the renal pedicle during the resection of the tumor |
Procedure: Clamp Robotic partial nephrectomy
Renal artery clamping during partial nephrectomy
|
| Experimental: Off clamp Laparoscopic robot-assisted partial nephrectomy without clamping the renal pedicle during the resection of the tumor |
Procedure: Clampless Robotic partial nephrectomy
Robotic partial nephrectomy without renal artery clamping
|
Outcome Measures
Primary Outcome Measures
- Glomerular Filtration Rate (GFR) variation [3-6 months]
difference between pre and post operative Glomerular Filtration Rate (GFR)
Secondary Outcome Measures
- Feasibility of clampless robotic partial nephrectomy [Duration of the surgical procedure]
number of cases shifted from clampless to clamping procedure; time of suture of the renal parenchyma; overall operative time.
- Morbidity of clampless robotic partial nephrectomy [90 days]
Estimated blood loss; pre/post operative variation of hemoglobin value; overall complications rate; bleeding complications rate
- Oncological safety of clampless robotic partial nephrectomy [15 days]
positive surgical margins rate
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
normal coagulation trim
-
pre operative Glomerular Filtration Rate (GFR) > 60 ml/min
-
healty contralateral kidney
-
low (4-6) or intermediate (7-10) RENAL score
-
availability of Da Vinci Robotic System
Exclusion Criteria:
-
altered coagulation trim
-
pre operative Glomerular Filtration Rate (GFR) < 60 ml/min
-
anatomic or functional solitary kidney
-
RENAL score >10
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Department of Urology, university Hospital Spedali Civili di Brescia | Brescia | Italy | 25123 |
Sponsors and Collaborators
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Investigators
- Principal Investigator: Alessandro Antonelli, Doctor, Spedali Civili di Brescia
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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. Epub 2007 Jun 6.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
Alessandro Antonelli,
Dr,
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
ClinicalTrials.gov Identifier:
NCT02287987
Other Study ID Numbers:
- CLOCKBS 1.1
First Posted:
Nov 11, 2014
Last Update Posted:
Jan 5, 2016
Last Verified:
Jan 1, 2016
Keywords provided by Alessandro Antonelli,
Dr,
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Additional relevant MeSH terms: