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

NCT ID: NCT07197385

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2025-06-10

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.

Conditions

Ureteral Calculi; Urolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group Laparoscopic Ureterolithotomy (LU)

Patients randomized to this group will undergo laparoscopic ureterolithotomy under general anesthesia. Prior to the procedure, an X-ray KUB will be performed to confirm the stone location. The patient will be placed in a flank position. Pneumoperitoneum will be created using a Veress needle, and three laparoscopic ports will be placed:

Port I (10 mm, sub-umbilical): for the 30° laparoscope

Port II (10 mm, mid-clavicular, iliac spine level): for stone extraction

Port III (5 mm, subcostal, mid-clavicular): for assistance and retraction

The stone will be identified as a ureteral bulge, confirmed by palpation with an atraumatic grasper. A longitudinal ureterotomy will be performed with a laparoscopic scalpel/L-hook, and the stone will be extracted via Port II. Large stones may be placed in a gloved finger pouch for retrieval at the end of surgery. The ureterotomy will be closed with interrupted 4-0 polyglactin sutures (two or three, depending on size). A 20F Nelaton tube drain will be

Group Type: EXPERIMENTAL

Laparoscopic Ureterolithotomy

Intervention Type: PROCEDURE

Keyhole laparoscopic approach to remove proximal ureteral stones by direct ureteral incision and closure.

Group Ureteroscopic Lithotripsy (URS)

Patients randomized to this group will undergo ureteroscopic lithotripsy under general or regional anesthesia. A cystoscopy and retrograde pyelogram will be performed first. A 6/7.5 Fr semirigid ureteroscope will be advanced through the ureteric orifice using a guidewire until the stone is visualized. Pneumatic lithotripsy will then be performed with the following settings:

Energy: 4 bar Frequency: 5 Hz

The stone will be fragmented into pieces <2 mm in size. A stone cone will be used to prevent retropulsion. Ureteric orifice dilatation will be performed if required. A DJ stent will be placed at the end of the procedure and will be removed at 4 weeks postoperatively. Antibiotic prophylaxis will be administered perioperatively.

Group Type: ACTIVE_COMPARATOR

Ureteroscopic Lithotripsy

Intervention Type: PROCEDURE

Semirigid ureteroscopic fragmentation of upper ureteral stones using pneumatic lithotripsy.

Interventions

Laparoscopic Ureterolithotomy

Keyhole laparoscopic approach to remove proximal ureteral stones by direct ureteral incision and closure.

Intervention Type: PROCEDURE

Ureteroscopic Lithotripsy

Semirigid ureteroscopic fragmentation of upper ureteral stones using pneumatic lithotripsy.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lahore General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Muhammad Irfan Jamil

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lahore General Hospital, Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

LahoreGeneralH11

Identifier Type: -

Identifier Source: org_study_id