CLamp vs Off Clamp Kidney During Partial Nephrectomy

Conditions

Glomerular Filtration Rate, Kidney Neoplasm, Nephrectomy

Keywords

Renal function, Off-clamp, Partial nephrectomy, Robotic, Hylar clamping

Brief summary

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

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).

2022-10-288 citations

10.1016/j.euros.2022.10.007

MP59-16 SHIFTING FROM PLANNED OFF-CLAMP TO ON-CLAMP APPROACH DURING PARTIAL NEPHRECTOMY: CROSS-ANALYSIS OF TWO RANDOMIZED TRIALS

Riccardo Bertolo, Pierluigi Bove, Marco Sandri, Luca Cindolo, Filippo Annino et al. (18 authors)

The Journal of Urology2021-08-04

10.1097/ju.0000000000002094.16

Is off-clamp robot-assisted partial nephrectomy beneficial for renal function? Data from the CLOCK trial.

Antonelli A, Cindolo L, Sandri M, Veccia A, Annino F, Bertagna F, Carini M, Celia A, D'Orta C, De Concilio B, Furlan M, Giommoni V, Ingrosso M, Mari A, Nucciotti R, Olianti C, Porreca A, Primiceri G, Schips L, Sessa F, Bove P, Simeone C, Minervini A, AGILE Group (Italian Group for Advanced Laparo-Endoscopic Surgery).

2021-07-0469 citations

10.1111/bju.15503

Safety of on- vs off-clamp robotic partial nephrectomy: per-protocol analysis from the data of the CLOCK randomized trial.

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).

2019-07-2433 citations

10.1007/s00345-019-02879-4

MP49-02 PERIOPERATIVE MORBIDITY OF CLAMP VS OFF-CLAMP ROBOTIC PARTIAL NEPHRECTOMY: PRELIMINARY RESULTS FROM A MULTICENTRE RANDOMIZED CLINICAL TRIAL (THE CLOCK STUDY)

Alessandro Antonelli, Luca Cindolo, Marco Sandri, Maria Furlan, Alessandro Veccia et al. (22 authors)

The Journal of Urology2017-04-014 citations

10.1016/j.juro.2017.02.1504

Interventions

PROCEDUREClamp Robotic partial nephrectomy

Renal artery clamping during partial nephrectomy

PROCEDUREClampless Robotic partial nephrectomy

Robotic partial nephrectomy without renal artery clamping

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed