Ureteral CalculiNCT07197385
Comparison of Ureteroscopic Lithotripsy and Laparoscopic Ureterolithotomy for the Treatment of Unilateral Upper Ureteral Stone
A study testing Laparoscopic Ureterolithotomy and Ureteroscopic Lithotripsy in people with Ureteral Calculi and Urolithiasis, run by Lahore General Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Calculi, Urolithiasis
- What is being tested?
- Laparoscopic Ureterolithotomy and Ureteroscopic Lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2025to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lahore General Hospital, Lahore
Lahore, Punjab Province, 54000
About this study
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.
Read more
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
- Being tested
- Laparoscopic Ureterolithotomy, Ureteroscopic Lithotripsy
- Keywords
- Ureteral Stones, Upper Ureteric Calculi, Ureteroscopic Lithotripsy, Ureteroscopy, Laparoscopic Ureterolithotomy
- Medical subject headings
- Ureteral Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic UreterolithotomyProcedure or surgery
Keyhole laparoscopic approach to remove proximal ureteral stones by direct ureteral incision and closure.
Ureteroscopic LithotripsyProcedure or surgery
Semirigid ureteroscopic fragmentation of upper ureteral stones using pneumatic lithotripsy.
| Study group | Role | What they receive |
|---|---|---|
| Group Laparoscopic Ureterolithotomy (LU) | Experimental | 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 Receives: Procedure: Laparoscopic Ureterolithotomy |
| Group Ureteroscopic Lithotripsy (URS) | Active comparator | 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. Receives: Procedure: Ureteroscopic Lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
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.
Measured: Intraoperative, recorded at the time of surgery
Stone-Free Rate (SFR)
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.
Measured: At 4 weeks postoperatively (before removal of DJ stent).
Secondary outcomes (1)
Postoperative Pain (VAS Score)
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.
Measured: Day of surgery and postoperative day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start10 Jan 2025
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Irfan Jamil, Lahore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197385
- Sponsor's protocol ID
- LahoreGeneralH11
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ureteroscopic Lithotripsy and Laparoscopic Ureterolithotomy for the Treatment of Unilateral Upper Ureteral Stone
- ClinicalTrials.gov ID
- NCT07197385
- Acronym / sponsor ID
- LahoreGeneralH11
- Conditions
- Ureteral Calculi, Urolithiasis
- Keywords
- Ureteral Stones, Upper Ureteric Calculi, Ureteroscopic Lithotripsy, Ureteroscopy, Laparoscopic Ureterolithotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Laparoscopic Ureterolithotomy (LU) | Experimental | Procedure: Laparoscopic UreterolithotomyPatients 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 Ureteroscopic Lithotripsy (URS) | Active comparator | Procedure: Ureteroscopic LithotripsyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic UreterolithotomyKeyhole laparoscopic approach to remove proximal ureteral stones by direct ureteral incision and closure. | Procedure or surgery | Group Laparoscopic Ureterolithotomy (LU) |
| Ureteroscopic LithotripsySemirigid ureteroscopic fragmentation of upper ureteral stones using pneumatic lithotripsy. | Procedure or surgery | Group Ureteroscopic Lithotripsy (URS) |
Primary outcome
Operative Time
Time frame: 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.
Stone-Free Rate (SFR)
Time frame: 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.
1 secondary outcome
Postoperative Pain (VAS Score)
Time frame: Day of surgery and postoperative day 1.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Ureterolithotomy and Ureteroscopic Lithotripsy in people with Ureteral Calculi and Urolithiasis, run by Lahore General Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative Time (time frame: Intraoperative, recorded at the time of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.