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

Primary Purpose

Renal Stone

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Retrograde Intrarenal Surgery

About this trial

This is an interventional treatment trial for Renal Stone focused on measuring Renal stone, Calculi, Retrograde Intrarenal Surgery, Flexible ureteroscope

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Urology and Nephrology Center
Amr A Elsawy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Flexible ureteroscope

Arm Description

Outcomes

Primary Outcome Measures

stone free rate (SFR)

stone free rate after the procedure

Secondary Outcome Measures

Predictors of operative time of the procedure

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

- 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.

- 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

• 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).

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.

Full Information

NCT ID

NCT03719456

First Posted

October 17, 2018

Last Updated

November 20, 2021

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT03719456

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

February 1, 2021 (Actual)

Study Completion Date

February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Stone

Keywords

Renal stone, Calculi, Retrograde Intrarenal Surgery, Flexible ureteroscope

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

340 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Flexible ureteroscope

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Retrograde Intrarenal Surgery

Other Intervention Name(s)

Flexible ureteroscope

Primary Outcome Measure Information:

Title

stone free rate (SFR)

Description

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 Outcome Measure Information:

Title

Predictors of operative time of the procedure

Description

Predictors of operative time of the procedure

Time Frame

Immediately after the procedure

Title

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

Description

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

Time Frame

within 30 days after the procedure

Title

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.

Description

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

Time Frame

Post operative day 1 after the procedure

Title

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

Description

• 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

Title

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

Description

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

Time Frame

within 3 months after the procedure

Title

Assessment of patient-reported outcomes using patient-reported outcomes measurements information system (PROMIS)

Description

Time Frame

within 3 months after the procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amr A Elsawy, MD

Organizational Affiliation

Urology and Nephrology Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Urology and Nephrology Center

City

Mansourah

State/Province

ZIP/Postal Code

35516

Country

Egypt

Facility Name

Amr A Elsawy

City

Al Manşūrah

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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