EndourologyNCT06199518
Minimally Invasive Techniques for Treating Large Proximal Ureteral Stones
A study testing transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS) in people with Endourology, run by Tanta University at 1 site in Egypt.
Trial summary
a prospective comparative study designed to compare the outcomes of transperitoneal Laparoscopic ureterolithotomy (T-LUL), mini-percutaneous antegrade ureteroscopy (A-URS) and retrograde ureteroscopy (R-URS) in treating patients with LPUS (15-20 mm). Read more about this study
- Who is it for?
- Ages 26 to 65 years
- Conditions the study is for
- Endourology
- What is being tested?
- transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 1 Apr 2023
- 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 26 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults patients
- large proximal ureteral stones(1.5-2 cm)
Who cannot join
- larger stones
- multiple stones
- bleeding tendency
- active UTI
- distal stricture
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urolgy Departement, Faculty of Medicine, Tanta University
Tanta, Outside U.S./Canada, 6620010
About this study
Official title: Comparison of Laparoscopic Ureterolithotomy, Retrograde Flexible Ureteroscopy, and Mini- Percutaneous Antegrade Ureteroscopic Lithotripsy for the Management of Large Proximal Ureteral Stones (1.5-2 cm): A Prospective Randomized Trial.
a prospective comparative study designed to compare the outcomes of transperitoneal Laparoscopic ureterolithotomy (T-LUL), mini-percutaneous antegrade ureteroscopy (A-URS) and retrograde ureteroscopy (R-URS) in treating patients with LPUS (15-20 mm). the following parameters were assessed and compared (demographic data and stones characteristics, Stone free rate and complications)
Read the detailed description
we aimed in the current study to comprehensively evaluate and to compare the outcome of transperitoneal laparoscopic ureterolithtomy, retrograde ureteroscopy and mini-percutaneous antegrade ureteroscopy for management of large proximal ureteric stone (15 -20 mm) with regards to; operative time, stone free rate, success rate, hospital stay and complications.
A total of 105 participants were enrolled in the trial between April 2021 and June 2023 to accomplish this. Inclusion criteria for this study included patients who had a single proximal Ureteral stone (between the pelvi ureteric junction and the upper border of the sacroiliac joint) measuring 15-20 mm in diameter.
Patients were randomly allocated to receive either TPLU, RURS, or Minin-perc Antegrade URS, with a 1:1:1 allocation ratio. After providing informed permission, the patients were randomly assigned to one of three groups: Group I (35 patients treated with TPLU), Group II (35 patients treated with RURS), and Group III (35 patients not treated with either TPLU or RURS) (Included 35 patients who were treated by Mini-perc Antegrade URS)
- Conditions
- Endourology
- Being tested
- transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)Procedure or surgery
extraction or fragmentation of large proximal ureteral stones via different minimally invasive procedures
| Study group | Role | What they receive |
|---|---|---|
| GROUP(A):transperitoneal laparoscopic ureterolithotomy (T-LUL) | Active comparator | extraction of proximal ureteral stones by laparoscopic surgery via transperitoneal approach Receives: Procedure: transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS) |
| GROUP (B):retrograde flexible ureteroscopy (R-URS) | Active comparator | laser lithotripsy of proximal ureteral stones via flexible ureteroscopy retrograde Receives: Procedure: transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS) |
| GROUP (C):Antegrade mini-percutaneous flexible ureteroscopy (A-URS) | Active comparator | laser lithotripsy of proximal ureteral stones via percutanous antegrade flexible ureteroscopy Receives: Procedure: transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate (SFR)
SFR is defined as no residual stones or fragments ≤ 4 mm.
Measured: immediate (initial SFR ) and 1 -month later (final SFR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Apr 2021
- Primary completion1 Dec 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndourologyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Zoeir, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199518
- Sponsor's protocol ID
- 34619/4/21
- Status last verified
- Dec 2023
- First submitted
- 28 Dec 2023
- Last updated
- 10 Jan 2024
- 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 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic Ureterolithotomy, Retrograde Flexible Ureteroscopy, and Mini- Percutaneous Antegrade Ureteroscopic Lithotripsy for the Management of Large Proximal Ureteral Stones (1.5-2 cm): A Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT06199518
- Acronym / sponsor ID
- 34619/4/21
- Conditions
- Endourology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 10 Jan 2024 (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.
a prospective comparative study designed to compare the outcomes of transperitoneal Laparoscopic ureterolithotomy (T-LUL), mini-percutaneous antegrade ureteroscopy (A-URS) and retrograde ureteroscopy (R-URS) in treating patients with LPUS (15-20 mm). the following parameters were assessed and compared (demographic data and stones characteristics, Stone free rate and complications)
Detailed description
we aimed in the current study to comprehensively evaluate and to compare the outcome of transperitoneal laparoscopic ureterolithtomy, retrograde ureteroscopy and mini-percutaneous antegrade ureteroscopy for management of large proximal ureteric stone (15 -20 mm) with regards to; operative time, stone free rate, success rate, hospital stay and complications.
A total of 105 participants were enrolled in the trial between April 2021 and June 2023 to accomplish this. Inclusion criteria for this study included patients who had a single proximal Ureteral stone (between the pelvi ureteric junction and the upper border of the sacroiliac joint) measuring 15-20 mm in diameter.
Patients were randomly allocated to receive either TPLU, RURS, or Minin-perc Antegrade URS, with a 1:1:1 allocation ratio. After providing informed permission, the patients were randomly assigned to one of three groups: Group I (35 patients treated with TPLU), Group II (35 patients treated with RURS), and Group III (35 patients not treated with either TPLU or RURS) (Included 35 patients who were treated by Mini-perc Antegrade URS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GROUP(A):transperitoneal laparoscopic ureterolithotomy (T-LUL) | Active comparator | Procedure: transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)extraction of proximal ureteral stones by laparoscopic surgery via transperitoneal approach |
| GROUP (B):retrograde flexible ureteroscopy (R-URS) | Active comparator | Procedure: transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)laser lithotripsy of proximal ureteral stones via flexible ureteroscopy retrograde |
| GROUP (C):Antegrade mini-percutaneous flexible ureteroscopy (A-URS) | Active comparator | Procedure: transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)laser lithotripsy of proximal ureteral stones via percutanous antegrade flexible ureteroscopy |
Who may qualify
- Ages
- 26 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults patients
- large proximal ureteral stones(1.5-2 cm)
Key exclusion criteria (5 listed)
- larger stones
- multiple stones
- bleeding tendency
- active UTI
- distal stricture
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 |
|---|---|---|
| transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)extraction or fragmentation of large proximal ureteral stones via different minimally invasive procedures | Procedure or surgery | GROUP (B):retrograde flexible ureteroscopy (R-URS), GROUP (C):Antegrade mini-percutaneous flexible ureteroscopy (A-URS), GROUP(A):transperitoneal laparoscopic ureterolithotomy (T-LUL) |
Primary outcome
stone free rate (SFR)
Time frame: immediate (initial SFR ) and 1 -month later (final SFR)
SFR is defined as no residual stones or fragments ≤ 4 mm.
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 10 Jan 2024.
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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 transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS) in people with Endourology, run by Tanta University at 1 site in Egypt.
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 2 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 10 Jan 2024. 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 Egypt. 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?
stone free rate (SFR) (time frame: immediate (initial SFR ) and 1 -month later (final SFR)). 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 10 Jan 2024.