Outcomes in Lower Pole Kidney Stone Management Using Mini-PCNL Compared With Retrograde Intra Renal Surgery

Kidney Stone Clinical Trial

Official title:

Outcomes in Lower Pole Kidney Stone Management Using Mini-PCNL Compared With Retrograde Intra Renal Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05714423
• Other study ID #: s12
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Services Hospital, Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Due to the anatomic characteristics of the lower calyx, lower pole stones are difficult to be eliminated through the ureter, even if the stones had been fragmented. Retrograde intrarenal surgery (RIRS) can be used to deal with lower pole stones of 1.0-2.0 cm, while percutaneous nephrolithotripsy (PCNL) is mainly used to deal with lower pole stones with larger diameter or when RIRS failed to resolve the stone. This study was conducted to compare mini PCNL and retrograde intrarenal surgery (RIRS) for the management of lower pole kidney stones in terms of efficacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Renal stone at lower pole of size 10mm -20mm

Exclusion Criteria:

• Patients with positive urine culture,
• Patients with anatomical abnormalities determined by ultrasonography
• Uncontrolled diabetes (HbA1c >9%)
• Patients undergone previous renal surgery

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stone
• Nephrolithiasis

Intervention

Procedure:
• Mini-PCNL
Mini-PCNL will done as follows. A 6 Fr ureteral catheter will be introduced through cystoscopy and dye will be instilled to opacify the pelvicalyceal system. After elaborating the calyceal system through fluoroscopy, selective calyceal will be punctured and tract will be dilated using 16 F sheath. Miniature nephroscope 14 Fr will be then introduced and stones will be fragmented by holmium: YAG laser. Afterwards the collecting system will be examined through nephroscope and fluoroscopic confirmation will be done to ensure complete stone clearance. In all the cases, 6 Fr 24 cm DJ stent will be placed and if remained uneventful, the patient will be discharged on postoperative day 2 with oral antibiotics.
• RIRS
RIRS will be performed as follows. In this procedure a double J stent will be placed to dilate the calyceal system 2 weeks prior the surgery. During the procedure, cystoscopy will be done, and 0.035-inch guide wire will be placed in the pelvi-calyceal system. Ureteric access sheath of 12 Fr will be placed and with the help of digital polyscope the stone will be fragmented using Holmium: YAG laser using 220 µm fiber. DJ stent 6F 24 cm will be placed in all the cases. In uneventful surgery patient will be discharged on postoperative day 1 with oral antibiotics

Locations

Country	Name	City	State
Pakistan	Shaikh Zayed Hospital Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Services Hospital, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone Clearance	Number of patients cleared from stones assessed by CT scan KUB	4 weeks
Secondary	Hospital Stay	Hospital stay will be assessed in days	1 week