Back to resultsOutcomes in Lower Pole Kidney Stone Management Using Mini-PCNL Compared With Retrograde Intra Renal Surgery
Primary Purpose
Kidney Stone
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mini-PCNL
RIRS
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Stone focused on measuring lower pole stone, mini PCNL, retrograde intrarenal surgery
Eligibility Criteria
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
Sites / Locations
- Shaikh Zayed Hospital Lahore
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Mini-PCNL Group
RIRS Group
Arm Description
In this group kidney stones will be treated with Mini-PCNL Surgery
In this group kidney stones will be treated with Retrograde Intrarenal Surgery.
Outcomes
Primary Outcome Measures
Stone Clearance
Number of patients cleared from stones assessed by CT scan KUB
Secondary Outcome Measures
Hospital Stay
Hospital stay will be assessed in days
Full Information
NCT ID
NCT05714423
First Posted
January 26, 2023
Last Updated
January 26, 2023
Sponsor
Services Hospital, Lahore
1. Study Identification
Unique Protocol Identification Number
NCT05714423
Brief Title
Outcomes in Lower Pole Kidney Stone Management Using Mini-PCNL Compared With Retrograde Intra Renal Surgery
Official Title
Outcomes in Lower Pole Kidney Stone Management Using Mini-PCNL Compared With Retrograde Intra Renal Surgery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Hospital, Lahore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone
Keywords
lower pole stone, mini PCNL, retrograde intrarenal surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mini-PCNL Group
Arm Type
Active Comparator
Arm Description
In this group kidney stones will be treated with Mini-PCNL Surgery
Arm Title
RIRS Group
Arm Type
Active Comparator
Arm Description
In this group kidney stones will be treated with Retrograde Intrarenal Surgery.
Intervention Type
Procedure
Intervention Name(s)
Mini-PCNL
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
RIRS
Intervention Description
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
Primary Outcome Measure Information:
Title
Stone Clearance
Description
Number of patients cleared from stones assessed by CT scan KUB
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Hospital Stay
Description
Hospital stay will be assessed in days
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shaikh Zayed Hospital Lahore
City
Lahore
State/Province
Punjab
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Outcomes in Lower Pole Kidney Stone Management Using Mini-PCNL Compared With Retrograde Intra Renal Surgery
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