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

NCT ID: NCT06761378

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-04

Brief Summary

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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

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Detailed Description

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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

Conditions

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Ureteric Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2 weeks Dj insertion

Renal stent for 2 weeks prior flexible uretroscopy

Group Type ACTIVE_COMPARATOR

Renal stent

Intervention Type PROCEDURE

Renal stent before flexible uretroscopy

Flexible uretroscopy

Intervention Type DEVICE

Renal stent for 2 weeks prior flexible uretroscopy

4weeks Dj insertion

Renal stent for 4 weeks prior flexible uretroscopy

Group Type ACTIVE_COMPARATOR

Renal stent

Intervention Type PROCEDURE

Renal stent before flexible uretroscopy

Flexible uretroscopy

Intervention Type DEVICE

Renal stent for 2 weeks prior flexible uretroscopy

Interventions

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Renal stent

Renal stent before flexible uretroscopy

Intervention Type PROCEDURE

Flexible uretroscopy

Renal stent for 2 weeks prior flexible uretroscopy

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Hossam Kandeel

Assistant lecturer of urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Menofia university

Cairo, State Or Province, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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5/2024UROL2

Identifier Type: -

Identifier Source: org_study_id

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