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

Renal Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719456
• Other study ID #: AE 2394
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: February 1, 2021

Study information

• Verified date: November 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Renal Stone

Intervention

Procedure:
• Retrograde Intrarenal Surgery

Locations

Country	Name	City	State
Egypt	Amr A Elsawy	Al Mansurah
Egypt	Urology and Nephrology Center	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Predictors of operative time of the procedure	Predictors of operative time of the procedure	Immediately after the procedure
Secondary	- 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
Secondary	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
Secondary	- 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
Secondary	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
Secondary	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