UrolithiasisNCT03919227
Measurement of Resistance During UAS Insertion Procedure in RIRS
A study testing empty bladder before inserting UAS and do not interfere with the filling degree of bladder in people with Urolithiasis, run by Guohua Zeng at 1 site in China.
Trial summary
Retrograde intrarenal surgery (RIRS) has been considered as the first-line choice for the management of <20mm kidney stones. Insertion of a ureteral access sheath (UAS) before RIRS surgery is currently accepted as an effective method to improve the effectiveness of surgery, but can be accompanied by serious… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- empty bladder before inserting UAS and do not interfere with the filling degree of bladder
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2018to Jun 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be a suitable operative candidate for RIRS
- Age 18 to 70 years
- Normal renal function 4 .ASA score Ⅰ and Ⅱ
- 5. Single renal or ureteral stone ≤20mm or multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) up to 20 mm
Who cannot join
- Uncorrected coagulopathy and active urinary tract infection (UTI)
- Severe cardiopulmonary dysfunction, can not tolerate sugery
- Patients who underwent transplant or urinary diversion
- Definite diagnosis of ureteral stricture or a history of stricture
- The bladder volume is less than 100ml
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230
Zhong Wen, Ph.D & MD., +8613631320020, gzgyzhongwen@163.com
About this study
Official title: Measurement of Resistance During UAS Insertion Procedure in RIRS: the Effects of Bladder Filling Degree and the Assessment of Ureter Injury.
Retrograde intrarenal surgery (RIRS) has been considered as the first-line choice for the management of <20mm kidney stones. Insertion of a ureteral access sheath (UAS) before RIRS surgery is currently accepted as an effective method to improve the effectiveness of surgery, but can be accompanied by serious complications. In long-term clinical practice, the investigators has found that different Bladder Filling Degree was accompanied by different Resistance During UAS Insertion Procedure in RIRS, which leads to the difference in success rate of UAS insertion.The investigator aims to perform a prospective and randomized controlled trial comparing the success rate of UAS insertion procedure under different bladder filling degree,and discuss the relationship between insertion resistance and ureter injury.
Read the detailed description
Upper urinary calculi is a common disease that endangers human health, Retrograde intrarenal surgery (RIRS) has been considered as the first-line choice for the management of <20mm kidney stones. Insertion of a ureteral access sheath (UAS) before RIRS surgery is currently accepted as an effective method to improve the effectiveness of surgery, for UAS can drain irrigation to reduce renal pelvic pressure and maintain vision clear. But incorrect way to insert UAS can be accompanied by serious complications. For instance, If the ureter was not dilated by DJ stent before RIRS surgery, or ureter was relatively narrow, the insertion of UAS would encounter great resistance. Sometimes the ureter was violently pushed into UAS, it might cause ureteral perforation or avulsion. As for how to insert UAS correctly, there is no unified international standard at present. Different surgeons have different experience. In long-term clinical practice, the investigators has found that different Bladder Filling Degree was accompanied by different Resistance During UAS Insertion Procedure in RIRS, which leads to the difference in success rate of UAS insertion. In addition, there seems to be some relationship between the resistance of UAS insertion and the ureter injury in surgery. Therefore, the investigator aims to perform a prospective and randomized controlled trial comparing the success rate of UAS insertion procedure under different bladder filling degree, and discuss the relationship between insertion resistance and ureter injury.
- Conditions
- Urolithiasis
- Being tested
- empty bladder before inserting UAS, do not interfere with the filling degree of bladder
- Keywords
- RIRS, Upper urinary calculi, Ureteral access sheath, Bladder filling degree, Ureteral injury
- Medical subject headings
- Urolithiasis, Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empty bladder before inserting UASProcedure or surgery
In group 1, investigator empty the bladder of urine with a catheter before inserting UAS, so that we can see if the empty bladder is easier for inserting UAS.
do not interfere with the filling degree of bladderProcedure or surgery
In group 2, investigator does not interfere with the filling degree of bladder before inserting UAS, so that we can see if the filling degree of bladder has impact on the insertion of UAS.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: empty bladder | Experimental | In group 1, investigator empty the bladder of urine with a catheter before inserting UAS. Receives: Procedure: empty bladder before inserting UAS |
| Group 2: natural state of bladder | Active comparator | In group 2, investigator does not interfere with the filling degree of bladder before inserting UAS. Receives: Procedure: do not interfere with the filling degree of bladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
UAS insertion success rate
Primary insertion of a UAS is not always successful. The ideal position of the UAS is with its distal extremity just below the ureteric-pelvic junction (UPJ). Insertion failure is defined as UAS cross the upj or do not reach the proximal ureter or the surgeon's decision to resign UAS insertion due to high resistance to the retrograde progression of the UAS along the urinary tract.
Measured: intraoperatively
Secondary outcomes (3)
Ureteral lesion grade
Base on post-ureteroscopic lesion scale (PULS), reported by Traxer O and Thomas A in 2013. UAS related ureteral injuries were divided into 5 grades according to ureteral wall anatomy. Grade 0 means no lesion found or only mucosal petechiae. Grade 1 means ureteral mucosal erosion without smooth muscle injury. Both Grade 0 and Grade 1 are considered as low-level injuries. Grade 2 means ureteral wall injury, including mucosa and smooth muscle, with adventitial preservation (periureteral fat not seen). Grade 3 means ureteral injury indicated ureteral perforation involving the full thickness of the ureteral wall, including the adventitia. Grade 4 means injury corresponded to total ureteral avulsion with complete rupture of ureteral continuity. Grade 2, 3 and 4 are high-level injuries.
Measured: intraoperatively
resistance of UAS insertion
The dynamometer was used to measure the resistance of UAS insertion procedure in both two groups, so as to analysis the relationship between bladder filling degree and inserting resistance.
Measured: intraoperatively
Complication rate
Complication is defined as any adverse event occurred intraoperatively or ≤1 month postoperatively, including intraoperative bleeding, postoperative pain and so on.The investigator will invaluate perioperative complications by modified Clavien system
Measured: 1 month after removing the pigtail stent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start12 Sep 2018
- Primary completionApr 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guohua Zeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Guohua Zeng, Ph.D and M.D, Study chair, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919227
- Sponsor's protocol ID
- MRER(78)2018
- Status last verified
- Apr 2019
- First submitted
- 15 Apr 2019
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Resistance During UAS Insertion Procedure in RIRS: the Effects of Bladder Filling Degree and the Assessment of Ureter Injury.
- ClinicalTrials.gov ID
- NCT03919227
- Acronym / sponsor ID
- MRER(78)2018
- Conditions
- Urolithiasis
- Keywords
- RIRS, Upper urinary calculi, Ureteral access sheath, Bladder filling degree, Ureteral injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guohua ZengUniversity, hospital or other
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 18 Apr 2019 (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.
Retrograde intrarenal surgery (RIRS) has been considered as the first-line choice for the management of <20mm kidney stones. Insertion of a ureteral access sheath (UAS) before RIRS surgery is currently accepted as an effective method to improve the effectiveness of surgery, but can be accompanied by serious complications. In long-term clinical practice, the investigators has found that different Bladder Filling Degree was accompanied by different Resistance During UAS Insertion Procedure in RIRS, which leads to the difference in success rate of UAS insertion.The investigator aims to perform a prospective and randomized controlled trial comparing the success rate of UAS insertion procedure under different bladder filling degree,and discuss the relationship between insertion resistance and ureter injury.
Detailed description
Upper urinary calculi is a common disease that endangers human health, Retrograde intrarenal surgery (RIRS) has been considered as the first-line choice for the management of <20mm kidney stones. Insertion of a ureteral access sheath (UAS) before RIRS surgery is currently accepted as an effective method to improve the effectiveness of surgery, for UAS can drain irrigation to reduce renal pelvic pressure and maintain vision clear. But incorrect way to insert UAS can be accompanied by serious complications. For instance, If the ureter was not dilated by DJ stent before RIRS surgery, or ureter was relatively narrow, the insertion of UAS would encounter great resistance. Sometimes the ureter was violently pushed into UAS, it might cause ureteral perforation or avulsion. As for how to insert UAS correctly, there is no unified international standard at present. Different surgeons have different experience. In long-term clinical practice, the investigators has found that different Bladder Filling Degree was accompanied by different Resistance During UAS Insertion Procedure in RIRS, which leads to the difference in success rate of UAS insertion. In addition, there seems to be some relationship between the resistance of UAS insertion and the ureter injury in surgery. Therefore, the investigator aims to perform a prospective and randomized controlled trial comparing the success rate of UAS insertion procedure under different bladder filling degree, and discuss the relationship between insertion resistance and ureter injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: empty bladder | Experimental | Procedure: empty bladder before inserting UASIn group 1, investigator empty the bladder of urine with a catheter before inserting UAS. |
| Group 2: natural state of bladder | Active comparator | Procedure: do not interfere with the filling degree of bladderIn group 2, investigator does not interfere with the filling degree of bladder before inserting UAS. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must be a suitable operative candidate for RIRS
- Age 18 to 70 years
- Normal renal function 4 .ASA score Ⅰ and Ⅱ
- 5. Single renal or ureteral stone ≤20mm or multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) up to 20 mm
Key exclusion criteria (5 listed)
- Uncorrected coagulopathy and active urinary tract infection (UTI)
- Severe cardiopulmonary dysfunction, can not tolerate sugery
- Patients who underwent transplant or urinary diversion
- Definite diagnosis of ureteral stricture or a history of stricture
- The bladder volume is less than 100ml
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 |
|---|---|---|
| empty bladder before inserting UASIn group 1, investigator empty the bladder of urine with a catheter before inserting UAS, so that we can see if the empty bladder is easier for inserting UAS. | Procedure or surgery | Group 1: empty bladder |
| do not interfere with the filling degree of bladderIn group 2, investigator does not interfere with the filling degree of bladder before inserting UAS, so that we can see if the filling degree of bladder has impact on the insertion of UAS. | Procedure or surgery | Group 2: natural state of bladder |
Primary outcome
UAS insertion success rate
Time frame: intraoperatively
Primary insertion of a UAS is not always successful. The ideal position of the UAS is with its distal extremity just below the ureteric-pelvic junction (UPJ). Insertion failure is defined as UAS cross the upj or do not reach the proximal ureter or the surgeon's decision to resign UAS insertion due to high resistance to the retrograde progression of the UAS along the urinary tract.
3 secondary outcomes
Ureteral lesion grade
Time frame: intraoperatively
resistance of UAS insertion
Time frame: intraoperatively
Complication rate
Time frame: 1 month after removing the pigtail stent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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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.
Guohua Zeng, Ph.D and M.D study chair
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing empty bladder before inserting UAS and do not interfere with the filling degree of bladder in people with Urolithiasis, run by Guohua Zeng at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 18 Apr 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guohua Zeng, Ph.D and M.D (+8613802916676, gzgyzgh@vip.tom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UAS insertion success rate (time frame: intraoperatively). 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 18 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.