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Completed

NCT Number: NCT05714423

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

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.

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Key information

Conditions

Kidney Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaikh Zayed Hospital Lahore

Lahore, Punjab Province, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mini-PCNL

Procedure

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

Procedure

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 outcomes

  1. Stone Clearance

    Time frame: 4 weeks

    Number of patients cleared from stones assessed by CT scan KUB

Secondary outcomes

  1. Hospital Stay

    Time frame: 1 week

    Hospital stay will be assessed in days

Sponsors and collaborators

Lead sponsor

Services Hospital, Lahore

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2023
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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