Measurement of Resistance During UAS Insertion Procedure in RIRS: the Effects of Bladder Filling Degree and the Assessment of Ureter Injury.

Measurement of Resistance During UAS Insertion Procedure in RIRS

Sponsors

Lead sponsor: Guohua Zeng

Source The First Affiliated Hospital of Guangzhou Medical University
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.

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.

Overall Status Recruiting
Start Date September 12, 2018
Completion Date June 2020
Primary Completion Date April 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
UAS insertion success rate intraoperatively
Secondary Outcome
Measure Time Frame
Ureteral lesion grade intraoperatively
resistance of UAS insertion intraoperatively
Complication rate 1 month after removing the pigtail stent
Enrollment 120
Condition
Intervention

Intervention type: Procedure

Intervention name: empty bladder before inserting UAS

Description: 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.

Arm group label: Group 1: empty bladder

Intervention type: Procedure

Intervention name: do not interfere with the filling degree of bladder

Description: 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.

Arm group label: Group 2: natural state of bladder

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Guohua Zeng, Ph.D and M.D Study Chair The First Affiliated Hospital of Guangzhou Medical University
Overall Contact

Last name: Guohua Zeng, Ph.D and M.D

Phone: +8613802916676

Email: [email protected]

Location
facility status contact
Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University Recruiting Zhong Wen, Ph.D & MD. +8613631320020 [email protected]
Location Countries

China

Verification Date

April 2019

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: The First Affiliated Hospital of Guangzhou Medical University

Investigator full name: Guohua Zeng

Investigator title: Vice president

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Group 1: empty bladder

Arm group type: Experimental

Description: In group 1, investigator empty the bladder of urine with a catheter before inserting UAS.

Arm group label: Group 2: natural state of bladder

Arm group type: Active Comparator

Description: In group 2, investigator does not interfere with the filling degree of bladder before inserting UAS.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov