Ideal Time of Stenting Prior to Ureteral Access Sheath for Stone Disease

NCT06761378 | Completed

• 1 other identifier: 5/2024UROL2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Ureteric Stone

Outcome Measures

Primary Outcomes (1)

• passage of access sheath after dilation of the ureter by DJ 2 vs 4 weeks

  Patients will classified in two groups, one will insert DJ for two weeks and the other insert DJ for four weeks then remove it and trial to insert access sheath for flexible uretroscopy duriing passage of the sheath the ureteric dilitation will be assessed if the sheath pass or not measure so , the ability of the ureteric dilitation to obtain the sheath is it dilated enough after 2 or 4 weeks

  6 months

Study Arms (2)

2 weeks Dj insertion

ACTIVE COMPARATOR

Renal stent for 2 weeks prior flexible uretroscopy

Procedure: Renal stent; Device: Flexible uretroscopy

4weeks Dj insertion

ACTIVE COMPARATOR

Renal stent for 4 weeks prior flexible uretroscopy

Procedure: Renal stent; Device: Flexible uretroscopy

Interventions

Renal stent PROCEDURE

Renal stent before flexible uretroscopy

2 weeks Dj insertion; 4weeks Dj insertion

Flexible uretroscopy DEVICE

Renal stent for 2 weeks prior flexible uretroscopy

2 weeks Dj insertion; 4weeks Dj insertion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Size more than 2 cm

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menofia university

Cairo, State Or Province, 32511, Egypt

Location

MeSH Terms

Conditions

Ureterolithiasis

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of urology

Model Details: 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

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 7, 2025
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 4, 2024
• Last Updated: January 7, 2025

Record last verified: 2024-12

Locations

EG (1)