Clinical trial NCT03719456: 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
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stone
Keywords: Renal stone
Calculi
Retrograde Intrarenal Surgery
Flexible ureteroscope
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: stone free rate (SFR)
timeFrame: It will be assessed by non contrast computed tomography for the participants one month after the procedure
Secondary outcomes:
measure: Predictors of operative time of the procedure
timeFrame: Immediately after the procedure
measure: - Post-operative complications using modified Dindo-Clavian grading system
timeFrame: within 30 days after the procedure
measure: 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.
timeFrame: Post operative day 1 after the procedure
measure: - Patient -reported outcomes about post operative pain using visual analogue scale
timeFrame: within 3 months after the procedure
measure: Patient -reported outcomes about General impression on the procedure using Freiburg Index of patient Satisfaction (FIPS).
timeFrame: within 3 months after the procedure
measure: Assessment of patient-reported outcomes using patient-reported outcomes measurements information system (PROMIS)
timeFrame: within 3 months after the procedure
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Urology and Nephrology Center
state: DK
city: Al Manşūrah
country: Egypt
facility: Amr A Elsawy
Study officials:
affiliation: Urology and Nephrology Center
name: Amr A Elsawy, MD
role: PRINCIPAL_INVESTIGATOR
References: