Clinical trial NCT05712785: Shuotongo Ureteroscopy for Upper Urinary Tract Stones
Official title: Clinical Study on the Treatment of Upper Urinary Tract Stones by Shuotong Scope
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Calculi
Ureterocele
Lead sponsor: Handan First Hospital
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to use the Shuotong ureteroscopy for surgical treatment of patients with upper urinary tract stones, taking advantage of the fact that the Shuotong mirror can be used for simultaneous lithotripsy and stone removal, thus maximizing the discharge of stones from the body and improving the stone removal rate.

Detailed description: Ureteroscopy via the natural lumen has the advantages of being non-invasive, safe and repeatable. This is where Shuotongo ureteroscopy, a new type of ureteroscopy, has not yet become fully popular. Usually, most patients with upper urinary tract stones are treated by ureteroscopy or with flexible ureteroscopy, because these endoscopes usually break the stones and ask the patient to drink more water to expel the stones by themselves, after the operation, it is usually easy to leave stones in the body, and some patients even form stone streets to block the ureter again after the operation. In some patients, stones may form again and obstruct the ureter again. The Shuotong Ureteroscopy has the advantages of stone crushing and stone removal, which can synchronize the process of stone crushing and stone removal and maintain a good surgical view. It has the advantages of simple operation, less trauma and high safety for the operation via natural channel, especially for the large stones in the upper urinary tract and Gantun stones.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Ureteral calculus Must be able to cooperate with the treatment

Exclusion Criteria:

* Patients had severe urinary tract infections; patients had other conditions which investigators thought not suitable for the study.

Primary outcomes:
measure: Stone removal rate
timeFrame: 1 week after surgery
Secondary outcomes:
measure: Surgery time
timeFrame: During surgery
Other outcomes:
Locations:
city: Handan
country: China
facility: Kunwu Yan
state: Hebei
Study officials:
affiliation: Handan First Hospital
name: kunwu yan, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lai L, Zhang W, Zheng F, Wang T, Bai P, Liu Z, Zheng J, Shao Z, Duan B, Wang H, Xing J, Chen H, Huang Y, Chen B. Comparison of the Efficacy of ShuoTong Ureteroscopy and Simple Flexible Ureteroscopy in the Treatment of Unilateral Upper Ureteral Calculi. Front Surg. 2021 Sep 27;8:707022. doi: 10.3389/fsurg.2021.707022. eCollection 2021.
citation: Qiao D, Cheng L, Xiaomei T, Baolei S, Yingyi L, Hui Z, Shaohua B, Wei L, U DY, Fangqiong D, Jie L, Shuangning L. Effect of ultra-mini percutaneous nephrolithotomy and ShuoTong ureteroscopy on the stress response, inflammatory indices, and urokinase level in patients with polycystic kidney disease complicated with renal calculus. Cell Mol Biol (Noisy-le-grand). 2022 Feb 4;67(5):309-316. doi: 10.14715/cmb/2021.67.5.42.
citation: Gan S, Guo Z, Zou Q, Gu C, Xiang S, Li S, Ye Z, Wang S. Diagnosis accuracy of PCA3 level in patients with prostate cancer: a systematic review with meta-analysis. Int Braz J Urol. 2020 Sep-Oct;46(5):786-793. doi: 10.1590/S1677-5538.IBJU.2019.0521.