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

January 26, 2023 updated by: Dr. SamiUllah, Services Hospital, Lahore

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Shaikh Zayed Hospital Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone Clearance
Time Frame: 4 weeks
Number of patients cleared from stones assessed by CT scan KUB
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Stay
Time Frame: 1 week
Hospital stay will be assessed in days
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Hospital, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2020

Primary Completion (ACTUAL)

November 30, 2022

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (ACTUAL)

February 6, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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