Clinical trial NCT06761378: Ideal Time of Stenting Prior to Ureteral Access Sheath for Stone Disease
Official title: Ideal Time of Stenting Prior to Ureteral Access Sheath for Stone Disease , Two vs Four Weeks Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteric Stone
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients and methods The study will be conducted at the urology departments at Menoufia University hospitals. Inclusion criteria: - All patients with stone kidney up to 2 cm, failed ESWL , difficult PCNL Exclusion criteria: - Size more than 2 cm Preoperative assessment by ✓ Full History • personal history ( name ,age ,sex ,residence , occupation , special habits ) • complain • past medical • Past surgical history • family history ✓ Investigations including - laboratory investigations(urine analysis ,CBC ,PT ,AST ,ALT ,Urea, S.creatinine, RBS - Imaging ( CT Urography , KUB) Operative : - Stenting either two weeks or four weeks - Feasibility of Usage of axis sheath - Operative Time - Stone residual - Stent postoperative Disposable flexible URS - Durability - Cost effectiveness Post operative : - complications
Primary purpose: TREATMENT

Brief summary: The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones . - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients. Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).\] - two types of flexible uretroscopy can be distinguished : fiberoptic and digital flexible URS. The difference between them is the image relay and light transmission. - Now either to use ureteral access sheath (AS) or not , but usage of AS decrease intrarenal pressure and clear vision by drainage of dust , so , for access of AS stent better to be inserted prior to the procedure ) So, there are little publications regarding the optimal timing of the stent In this study we will assess the feasibility of passage AS after two versus four weeks from stent insertion

Detailed description: The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones . - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients. Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).\] - two types of flexible uretroscopy can be distinguished. The difference between them is the image relay and light transmission. - Now either to use ureteral access sheath (AS) or not , but usage of AS decrease intrarenal pressure and clear vision by drainage of dust , so , for access of AS stent better to be inserted prior to the procedure ) So, there are little publications regarding the optimal timing of the stent In this study we will assess the feasibility of passage AS after two versus four weeks from stent insertion

Eligibility criteria: Inclusion Criteria:

* All patients with stone kidney up to 2 cm
* failed ESWL (extracorporeal shock wave lithotripsy)
* difficult PCNL (percutaneous nephrolithotomy)

Exclusion Criteria:

* Size more than 2 cm

Primary outcomes:
measure: passage of access sheath after dilation of the ureter by DJ 2 vs 4 weeks
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Menofia university
state: State Or Province
Study officials:
References: