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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Measurement of Resistance During UAS Insertion Procedure in RIRS

Clinicaltrials.gov identifier NCT03919227

Recruitment Status Recruiting

First Posted April 18, 2019

Last update posted April 18, 2019

Study Description

Brief 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 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.

  • Condition or Disease:Urolithiasis
  • Intervention/Treatment: Procedure: empty bladder before inserting UAS
    Procedure: do not interfere with the filling degree of bladder
  • Phase: N/A
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
  • Study Type: Interventional
  • Estimated Enrollment: 120 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Measurement of Resistance During UAS Insertion Procedure in RIRS: the Effects of Bladder Filling Degree and the Assessment of Ureter Injury.
  • Actual Study Start Date: September 2018
  • Estimated Primary Completion Date: April 2020
  • Estimated Study Completion Date: June 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Group 1: empty bladder
In group 1, investigator empty the bladder of urine with a catheter before inserting UAS.
Procedure: empty bladder before inserting UAS
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.
Active Comparator: Group 2: natural state of bladder
In group 2, investigator does not interfere with the filling degree of bladder before inserting UAS.
Procedure: do not interfere with the filling degree of bladder
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.
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. Ureteral lesion grade [ Time Frame: intraoperatively ]
    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.
  • 2. resistance of UAS insertion [ Time Frame: intraoperatively ]
    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.
  • 3. Complication rate [ Time Frame: 1 month after removing the pigtail stent ]
    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
Eligibility Criteria
  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. Patients must be a suitable operative candidate for RIRS

2. Age 18 to 70 years

3. 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

Exclusion Criteria:

1. Uncorrected coagulopathy and active urinary tract infection (UTI)

2. Severe cardiopulmonary dysfunction, can not tolerate sugery

3. Patients who underwent transplant or urinary diversion

4. Definite diagnosis of ureteral stricture or a history of stricture

5. The bladder volume is less than 100ml

Contacts and Locations
Contacts

Contact: Guohua Zeng, Ph.D and M.D +8613802916676 gzgyzgh@vip.tom.com

Contact: Wen Zhong, Ph.D and M.D +8613631320020 gzgyzhongwen@163.com

Locations

China, Guangdong
Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou

Sponsors and Collaborators

Guohua Zeng

Investigators

Study Chair: Guohua Zeng, Ph.D and M.D The First Affiliated Hospital of Guangzhou Medical University

More Information
  • Responsible Party: Guohua Zeng
  • ClinicalTrials.gov Identifier: NCT03919227 History of Changes
  • Other Study ID Numbers: MRER(78)2018
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: April 18, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Guohua Zeng: RIRS
    Upper urinary calculi
    Ureteral access sheath
    Bladder filling degree
    Ureteral injury
  • Additional relevant MeSH terms: Urolithiasis