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

Sponsor

Services Hospital, Lahore (Other)

Overall Status

Completed

CT.gov ID

NCT05714423

Collaborator

(none)

150

Enrollment

Location

Arms

Actual Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone	Procedure: Mini-PCNL Procedure: RIRS	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Nov 30, 2022

Actual Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mini-PCNL Group In this group kidney stones will be treated with Mini-PCNL Surgery	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.
Active Comparator: RIRS Group In this group kidney stones will be treated with Retrograde Intrarenal Surgery.	Procedure: 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

Arm

Intervention/Treatment

Active Comparator: Mini-PCNL Group

In this group kidney stones will be treated with Mini-PCNL Surgery

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.

Active Comparator: RIRS Group

In this group kidney stones will be treated with Retrograde Intrarenal Surgery.

Procedure: 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

Outcome Measures

Primary Outcome Measures

Stone Clearance [4 weeks]
Number of patients cleared from stones assessed by CT scan KUB

Secondary Outcome Measures

Hospital Stay [1 week]
Hospital stay will be assessed in days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shaikh Zayed Hospital Lahore	Lahore	Punjab	Pakistan

Sponsors and Collaborators

Services Hospital, Lahore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. SamiUllah, Principal Investigator, Services Hospital, Lahore

ClinicalTrials.gov Identifier:

NCT05714423

Other Study ID Numbers:

First Posted:

Feb 6, 2023

Last Update Posted:

Feb 6, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. SamiUllah, Principal Investigator, Services Hospital, Lahore

lower pole stone, mini PCNL, retrograde intrarenal surgery

Additional relevant MeSH terms:

Kidney Calculi

Nephrolithiasis

Calculi

Study Results

No Results Posted as of Feb 6, 2023