ROBOTIC PYELOLITHIOTOMY VERSUS PERCUTANEOUS NEPHROLITHOTOMY (PCNL).

Renal Stone Clinical Trial

Official title:

ROBOTIC PYELOLITHIOTOMY VERSUS PERCUTANEOUS NEPHROLITHOTOMY (PCNL).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03046888
• Other study ID #: SJ-598
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: February 13, 2020

Study information

• Verified date: February 2020
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 13, 2020
• Est. primary completion date: February 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Renal Stone

Intervention

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.

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative hospital stay	the length of hospital stay efter each procedure	30 days
Secondary	Stones free rate		6 months