ROBOTIC PYELOLITHIOTOMY VERSUS PERCUTANEOUS NEPHROLITHOTOMY (PCNL).

Not Applicable

Completed

• Conditions: Renal Stone
• Interventions: Procedure: Robot assisted pyelolithotomy

• Registration Number: NCT03046888
• Lead Sponsor: Zealand University Hospital

Brief Summary

Prospectively randomized study in patients with renal pelvic stones who are candidate to standard PCNL procedure. One to one, controlled clinical trial. Patients will be randomly allocated into two groups, 20 patients in each group. Group A will be scheduled to receive routine standard PCNL. Group B will be scheduled to receive Robot assisted pyelolethotomy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-05
• Study First Submitted QC: 2017-02-05
• Study First Posted: 2017-02-08
• Study Start: 2017-10-01
• Status Verified: 2020-02
• Primary Completion: 2020-02-13
• Study Completion: 2020-02-13
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age above 18 years.
2. Renal stones ≥2 cm.
3. Patients are candidate to PCNL.
4. Patient with ECOG performance score of 2 and less.
5. Able to give informed consent
6. Able to discharges home at the same day.

Exclusion Criteria

1. Renal stones < 2cm and can managed by another technique.
2. Known with psychological disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCNL	Robot assisted pyelolithotomy	Percutant nephrolithotomy is a standard procedure for stones treatment over 2 cm.The puncture will be performed with an 18-G nephrostomy needle. The access thus gained guaranteed the transpapillary route of the percutaneous tract, a basic condition for the prevention of bleeding. Subsequently, following withdrawal of the puncture needle and urine drainage, a flexible guidewire will be inserted and advanced to the upper calyx or ureter.
Robot assisted pyelolithotomy	Robot assisted pyelolithotomy	Robot assisted pyelolithotomy, is a new technique to remove stones of more than 2 cm. A 12-mm camera port is placed at the level of the umbilicus and lateral. Two 8-mm robotic trocars are placed under direct vision and a 12-mm assistant port is placed in the midline a 5-8 cm above the umbilicus. After reflecting the colon medially, the renal pelvis will be dissected and identified, a flexible cystoscope will be inserted via an assisted trocar and introduced into the renal pelvis through a minor incision. The kidney stones will then be extracted with a basket and either removed via the port or placed in a specimen retrieval bag.

Primary Outcome Measures

Name	Time	Method
Postoperative hospital stay	30 days	the length of hospital stay efter each procedure

Secondary Outcome Measures

Name	Time	Method
Stones free rate	6 months

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Roskilde, Denmark