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Prospective Assessment of Procedure-Related and Patient-Reported Outcomes After Retrograde Intrarenal Surgery (RIRS) for Renal Calculi Less Than 20 mm

NCT ID: NCT03719456

Last Updated: 2021-11-23

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

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2021-02-01

Brief Summary

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The investigators aim at this study to prospectively assess procedure-related outcomes after RIRS for renal calculi less than 20 mm, including stone free rate (SFR), predictors of successful outcome, complications types/rate, readmission rate and the need of auxiliary procedures. In addition, patient-reported outcomes after this modality of intervention are going to be assessed.

Detailed Description

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Conditions

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Renal Stone

Keywords

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Renal stone Calculi Retrograde Intrarenal Surgery Flexible ureteroscope

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Flexible ureteroscope

Group Type EXPERIMENTAL

Retrograde Intrarenal Surgery

Intervention Type PROCEDURE

Interventions

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Retrograde Intrarenal Surgery

Intervention Type PROCEDURE

Other Intervention Names

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Flexible ureteroscope

Eligibility Criteria

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Inclusion Criteria

1. Ability to give informed consent.
2. Stone criteria:

* Less than 20 mm.
* Infectious stone.
* Growing stone on follow-up.
3. Kidney criteria:

* Obstructing stone causing hydronephrosis.
* Solitary kidney or bilateral renal stones.
4. Patients criteria:

* Age ≥18 years.
* Symptomatic stone causing pain or hematuria.
* Patient comorbidity omitting other modalities as bleeding diathesis or skeletal deformities.
* Patient preference or patients' social situation concerning profession or amount of travel

Exclusion Criteria

1. Inability to give informed consent.
2. Stone criteria:

* More than 20 mm.
* Peripheral calyceal asymptomatic stone static in size on follow-up.
* Unsuitable/failure of initial treatment modalities (oral dissolution therapy-SWL) for stones less than 20 mm.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Amr Abdel-Lateif El-Sawy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr A Elsawy, MD

Role: PRINCIPAL_INVESTIGATOR

Urology and Nephrology Center

Locations

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Urology and Nephrology Center

Al Mansurah, DK, Egypt

Site Status

Amr A Elsawy

Al Manşūrah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AE 2394

Identifier Type: -

Identifier Source: org_study_id