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RECRUITING
NCT07261995
NA

Comparison of Extracorporeal Shock Wave Lithotripsy Versus Retrograde Intrarenal Surgery in the Management of Renal Calculi

Sponsor: Ziauddin Hospital

View on ClinicalTrials.gov

Summary

This study is being carried out in patients with kidney stones measuring between 1 and 2 centimeters. Kidney stones are common in Pakistan and can cause severe pain, infection, and repeated hospital visits. Two commonly used treatments for stones of this size are extracorporeal shock wave lithotripsy (ESWL) and retrograde intrarenal surgery (RIRS). ESWL uses shock waves applied from outside the body to break the stone into small fragments that can pass in the urine. RIRS is a minimally invasive endoscopic procedure in which a thin flexible scope is passed through the urinary passage into the kidney and a laser is used to break the stone. Adult patients aged 18 to 65 years with a single kidney stone of 1-2 cm will be included. According to the urologist's clinical judgment and patient preference, individuals will undergo either ESWL (Group A) as a day-care shock wave procedure or RIRS (Group B) under general anesthesia using a laser. All patients will receive standard care before and after the procedure and will be followed for 28 days. The study will compare how completely the stone is cleared (based on a CT scan), how long patients stay in hospital, how much pain they feel after the procedure, and whether they develop visible blood in the urine or signs of infection such as fever and raised white cell count. The need for any further procedure for the same stone will also be recorded. The central hypothesis is that there is a meaningful difference between ESWL and RIRS in stone clearance, safety, pain, and need for retreatment. The findings are expected to help doctors and patients choose the most suitable treatment for kidney stones of this size in routine practice.

Official title: Comparison of Outcomes of Extracorporeal Shock Wave Lithotripsy Versus Retrograde Intrarenal Surgery in the Management of Renal Calculi Measuring 1 to 2 Centimeters

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2025-09-05

Completion Date

2026-02-05

Last Updated

2025-12-03

Healthy Volunteers

No

Interventions

PROCEDURE

Extracorporeal Shock Wave Lithotripsy (ESWL)

Extracorporeal shock wave lithotripsy delivered as an outpatient procedure under sedation, using a standard lithotripter. Shock waves are applied at 60-100 impulses per minute, up to a maximum of 3000 shocks per session, to fragment a 1-2 centimeter renal calculus. Patients receive standard analgesia, hydration counselling, and antibiotic prophylaxis according to hospital protocol.

PROCEDURE

Retrograde Intrarenal Surgery (RIRS)

Retrograde intrarenal surgery performed under general anesthesia after prior placement of a 5 Fr double-J ureteral stent. A flexible ureteroscope introduced via the urethra and ureteral access sheath is used to visualise the renal stone. Stone disintegration is achieved with a Holmium:YAG laser (0.5-1.2 Joules, 20-40 Hertz) using dusting or fragmentation, followed by placement of a double-J stent for three weeks. Standard postoperative analgesia, antibiotics, and hydration advice are given.

Locations (1)

Ziauddin Hospital

Karachi, Sindh, Pakistan