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

N/ACompletedNCT03719456

Mansoura University340 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

340

Conditions

Renal Stone

Interventions

Retrograde Intrarenal SurgeryPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Urology and Nephrology Center

Al Mansurah, DK, Egypt

Amr A Elsawy

Al Manşūrah, Egypt

Outcomes

Primary Outcomes

stone free rate (SFR)

stone free rate after the procedure

Time frame: It will be assessed by non contrast computed tomography for the participants one month after the procedure

Secondary Outcomes

Predictors of operative time of the procedure

Time frame: Immediately after the procedure

- Post-operative complications using modified Dindo-Clavian grading system

\- Post-operative complications (Type/rate/predictors) using modified Dindo-Clavian grading system

Time frame: within 30 days after the procedure

Intra-operative clinical judgment of the surgeon on stone free status using flouroscopy and visual scanning of pelvicalyceal system and its relation to post-operative NCCT.

\- Intra-operative surgeon perspective about procedure outcome and its relation to post-operative NCCT.

Time frame: Post operative day 1 after the procedure

- Patient -reported outcomes about post operative pain using visual analogue scale

• Post-operative pain: Postoperative pain will be evaluated in all patients by using visual analogue scale (VAS). The impact of patient-related, stone-related and procedure-related factors.

Time frame: within 3 months after the procedure

Patient -reported outcomes about General impression on the procedure using Freiburg Index of patient Satisfaction (FIPS).

Time frame: within 3 months after the procedure

Data from ClinicalTrials.gov

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