Comparison of Ureteroscopic Lithotripsy and Laparoscopic Ureterolithotomy for the Treatment of Unilateral Upper Ureteral Stone

Not Applicable

Completed

• Conditions: Ureteral Calculi; Urolithiasis

• Registration Number: NCT07197385
• Lead Sponsor: Lahore General Hospital

Brief Summary

Kidney stones are a common health problem that can cause severe pain, blockage of urine flow, and even long-term kidney damage if left untreated. When stones move from the kidney into the upper part of the ureter (the tube that carries urine to the bladder), treatment often becomes more difficult. Several treatment options are available, including breaking the stones with sound waves, removing them with small telescopes, or performing surgery. However, the best method for larger stones in the upper ureter is still debated.

This study will compare two commonly used minimally invasive surgical techniques for removing upper ureteral stones. The first method is ureteroscopic lithotripsy (URS), in which a thin scope is passed through the urinary passage to directly reach the stone and break it into small pieces using a pneumatic device. The second method is laparoscopic ureterolithotomy (LU), a keyhole surgical procedure in which small incisions are made in the abdomen, and the stone is removed directly through the ureter.

Fifty-six adult patients with a single upper ureteral stone measuring 10-20 mm will be randomly assigned to either URS or LU. Both groups will undergo standard preoperative evaluations, and infection will be treated before surgery. The outcomes will be assessed in terms of operation time, length of hospital stay, level of postoperative pain, use of pain medications, complications during or after surgery, and the stone-free rate (absence of residual stone fragments larger than 3 mm after four weeks).

By comparing these two procedures, this study aims to identify which treatment is safer and more effective for patients with upper ureteral stones. The results will provide useful evidence to guide doctors and patients in making the best treatment choices.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-10
• Primary Completion: 2025-06-10
• Study Completion: 2025-06-10
• Status Verified: 2025-09
• Study First Submitted: 2025-09-21
• Study First Submitted QC: 2025-09-21
• Last Update Submitted: 2025-09-21
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Patients of both genders with age ≥ 18 years.
• Patients with a duration of symptoms for more than 1 month.
• Patients having a unilateral single stone of 10 mm to 20 mm in diameter, located between the ureteropelvic junction and the upper border of the sacroiliac joint (upper ureteral stone).

Exclusion Criteria

• Patients with a history of ipsilateral ureteric surgeries, previous open abdominal surgeries, bleeding disorders and pregnancy.
• Before surgery, patients had a positive urine culture, fever (37.60c) and leukocytosis > 12.000 per microliter.
• Patients having solitary kidney and co-morbidities e.g., cardiovascular, Liver, respiratory illnesses, or serum creatinine >1.5 mg/dl.
• Horseshoe kidneys, pelvic kidneys, pyonephrosis, ureteropelvic junction blockage, and ureteral stricture.
• Patients with unsuitable for general anesthesia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stone-Free Rate (SFR)	At 4 weeks postoperatively (before removal of DJ stent).	The stone-free rate will be defined as the absence of residual stone fragments \>3 mm, confirmed by radiological imaging (X-ray KUB or NCCT) at follow-up. Patients with residual fragments ≤3 mm will be considered stone-free, while those with larger fragments or requiring auxiliary procedures will be considered not stone-free.
Operative Time	Intraoperative, recorded at the time of surgery	Operative time will be measured from the start of the surgical procedure until urethral catheterization is completed. The duration will be recorded in minutes for each patient and compared between ureteroscopic lithotripsy and laparoscopic ureterolithotomy groups.

Secondary Outcome Measures

Name	Time	Method
Postoperative Pain (VAS Score)	Day of surgery and postoperative day 1.	Pain intensity will be assessed using a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst pain). Scores will be recorded on the day of surgery and the first postoperative day. Analgesic use (mg dose administered) will also be documented.

Trial Locations

Locations (1)

Lahore General Hospital, Lahore; 🇵🇰 Lahore, Punjab Province, Pakistan