ROBOTIC PYELOLITHIOTOMY VERSUS PERCUTANEOUS NEPHROLITHOTOMY (PCNL).

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.

Study Overview

• Status: Completed
• Conditions: Renal Stone
• Intervention / Treatment: Procedure: Robot assisted pyelolithotomy

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Roskilde, Denmark, 4000
    • Zealand University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PCNL; 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.	Procedure: Robot assisted pyelolithotomy; A 12-mm camera port is placed at the level of the umbilicus and lateral; this port is moved farther laterally in morbidly obese patients to allow for the instruments to reach the target organs. 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. For right-sided stones, an additional 5-mm port is placed in the midline just below the xiphoid process for liver retraction. Placement of the trocars can be changed according to surgeon preference. 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.
Experimental: 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.	Procedure: Robot assisted pyelolithotomy; A 12-mm camera port is placed at the level of the umbilicus and lateral; this port is moved farther laterally in morbidly obese patients to allow for the instruments to reach the target organs. 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. For right-sided stones, an additional 5-mm port is placed in the midline just below the xiphoid process for liver retraction. Placement of the trocars can be changed according to surgeon preference. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative hospital stay	the length of hospital stay efter each procedure	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Stones free rate	6 months

Collaborators and Investigators

• Sponsor: Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): February 13, 2020
• Study Completion (Actual): February 13, 2020

Study Registration Dates

• First Submitted: February 5, 2017
• First Submitted That Met QC Criteria: February 5, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: SJ-598

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No