CLamp vs Off Clamp Kidney During Partial Nephrectomy (CLOCK)

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status: Unknown

Conditions: Glomerular Filtration Rate; Kidney Neoplasm; Nephrectomy

Treatments: Procedure: Clampless Robotic partial nephrectomy; Procedure: Clamp Robotic partial nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02287987

CLOCKBS 1.1

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Clamp

Active Comparator group

Description:

Laparoscopic robot-assisted partial nephrectomy with clamping the renal pedicle during the resection of the tumor

Treatment:

Procedure: Clamp Robotic partial nephrectomy

Off clamp

Experimental group

Description:

Laparoscopic robot-assisted partial nephrectomy without clamping the renal pedicle during the resection of the tumor

Treatment:

Procedure: Clampless Robotic partial nephrectomy