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

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT03719456

Collaborator

(none)

340

Enrollment

Locations

Arm

Actual Duration (Months)

170

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Stone	Procedure: Retrograde Intrarenal Surgery	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

340 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Feb 1, 2021

Actual Study Completion Date :

Feb 1, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Flexible ureteroscope

Procedure: Retrograde Intrarenal Surgery

Other Names:

Flexible ureteroscope

Outcome Measures

Primary Outcome Measures

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

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
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.
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).
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Ability to give informed consent.
Stone criteria:

Less than 20 mm.
Infectious stone.
Growing stone on follow-up.

Kidney criteria:

Obstructing stone causing hydronephrosis.
Solitary kidney or bilateral renal stones.

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:

Inability to give informed consent.
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.