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

Not Applicable

Completed

• Conditions: Renal Stone
• Interventions: Procedure: Retrograde Intrarenal Surgery

• Registration Number: NCT03719456
• Lead Sponsor: Mansoura University

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-25
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-20
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Flexible ureteroscope	Retrograde Intrarenal Surgery	-

Primary Outcome Measures

Name	Time	Method
stone free rate (SFR)	It will be assessed by non contrast computed tomography for the participants one month after the procedure	stone free rate after the procedure

Secondary Outcome Measures

Name	Time	Method
Predictors of operative time of the procedure	Immediately after the procedure	Predictors of operative time of the procedure
- Post-operative complications using modified Dindo-Clavian grading system	within 30 days after the procedure	- Post-operative complications (Type/rate/predictors) using modified Dindo-Clavian grading system
Patient -reported outcomes about General impression on the procedure using Freiburg Index of patient Satisfaction (FIPS).	within 3 months after the procedure	Patient -reported outcomes about General impression on the procedure using Freiburg Index of patient Satisfaction (FIPS).
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.	Post operative day 1 after the procedure	- Intra-operative surgeon perspective about procedure outcome and its relation to post-operative NCCT.
- Patient -reported outcomes about post operative pain using visual analogue scale	within 3 months after the procedure	• 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.
Assessment of patient-reported outcomes using patient-reported outcomes measurements information system (PROMIS)	within 3 months after the procedure	Procedure impact on improvement in patient-reported outcomes measurements information system (PROMIS): PROMIS is a National Institute of Health (NIH) validated system to assess patient quality of life. The PROMIS survey consists of 43 questions assessing the following categories: anxiety/fear, depression/ sadness, fatigue, pain interference, physical function, and sleep disturbance.

Trial Locations

Locations (2)

Amr A Elsawy; 🇪🇬 Al Manşūrah, Egypt

Urology and Nephrology Center; 🇪🇬 Mansourah, DK, Egypt