Measurement of Resistance During UAS Insertion Procedure in RIRS

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03919227
• Other study ID #: MRER(78)2018
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2018
• Est. completion date: June 2020

Study information

• Verified date: April 2019
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Guohua Zeng, Ph.D and M.D
• Phone: +8613802916676
• Email: gzgyzgh[@]vip.tom.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ? and ?

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

Related Conditions & MeSH terms

• Urolithiasis

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Guohua Zeng

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	intraoperatively
Secondary	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.	intraoperatively
Secondary	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.	intraoperatively
Secondary	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	1 month after removing the pigtail stent