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

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 Overview

• Status: Completed
• Conditions: Renal Stone
• Intervention / Treatment: Procedure: Retrograde Intrarenal Surgery

• Study Type: Interventional
• Enrollment (Actual): 340
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Manşūrah, Egypt, 35516
    • Amr A Elsawy
  • DK
    • Mansourah, DK, Egypt, 35516
      • Urology and nephrology center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flexible ureteroscope	Procedure: Retrograde Intrarenal Surgery; Other Names: Flexible ureteroscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stone free rate (SFR)	stone free rate after the procedure	It will be assessed by non contrast computed tomography for the participants one month after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictors of operative time of the procedure	Predictors of operative time of the procedure	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	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.	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.	within 3 months after the procedure
Patient -reported outcomes about General impression on the procedure using Freiburg Index of patient Satisfaction (FIPS).	Patient -reported outcomes about General impression on the procedure using Freiburg Index of patient Satisfaction (FIPS).	within 3 months after the procedure
Assessment of patient-reported outcomes using patient-reported outcomes measurements information system (PROMIS)	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.	within 3 months after the procedure

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Amr A Elsawy, MD, Urology and nephrology center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 20, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Calculi; Retrograde Intrarenal Surgery; Renal stone; Flexible ureteroscope
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: AE 2394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No