Renal Stone
Conditions
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.
Interventions
PROCEDURERobot 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.
Sponsors
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
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 RP.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative hospital stay | 30 days | the length of hospital stay efter each procedure |
Secondary
| Measure | Time frame |
|---|---|
| Stones free rate | 6 months |
Countries
Denmark
Outcome results
None listed