CLamp vs Off Clamp Kidney During Partial Nephrectomy

Not Applicable

• Conditions: Glomerular Filtration Rate; Nephrectomy; Kidney Neoplasm
• Interventions: Procedure: Clamp Robotic partial nephrectomy; Procedure: Clampless Robotic partial nephrectomy

• Registration Number: NCT02287987
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brief Summary

Prospective, randomized trial comparing surgical, functional and oncological outcomes between clamp and clamp-less robot assisted partial nephrectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-11-07
• Study First Posted: 2014-11-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-03
• Last Update Posted: 2016-01-05
• Primary Completion: 2016-10
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clamp	Clamp Robotic partial nephrectomy	Laparoscopic robot-assisted partial nephrectomy with clamping the renal pedicle during the resection of the tumor
Off clamp	Clampless Robotic partial nephrectomy	Laparoscopic robot-assisted partial nephrectomy without clamping the renal pedicle during the resection of the tumor

Primary Outcome Measures

Name	Time	Method
Glomerular Filtration Rate (GFR) variation	3-6 months	difference between pre and post operative Glomerular Filtration Rate (GFR)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Clinical Department of Urology, university Hospital Spedali Civili di Brescia; 🇮🇹 Brescia, Italy