CLamp vs Off Clamp Kidney During Partial Nephrectomy (CLOCK)

January 3, 2016 updated by: Alessandro Antonelli, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Prospective Randomized Trial Comparing Clamp Versus Clampless Robot Assisted Partial Nephrectomy

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25123
        • Clinical Department of Urology, university Hospital Spedali Civili di Brescia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glomerular Filtration Rate (GFR) variation
Time Frame: 3-6 months
difference between pre and post operative Glomerular Filtration Rate (GFR)
3-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of clampless robotic partial nephrectomy
Time Frame: Duration of the surgical procedure
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
Time Frame: 90 days
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
Time Frame: 15 days
positive surgical margins rate
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Investigators

  • Principal Investigator: Alessandro Antonelli, Doctor, Spedali Civili di Brescia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ANTICIPATED)

October 1, 2016

Study Completion (ANTICIPATED)

October 1, 2016

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (ESTIMATE)

November 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 3, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLOCKBS 1.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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