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Clinical Trials/NCT03719456
NCT03719456CompletedNot Applicable

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

Mansoura University2 sites in 1 country340 target enrollmentStarted: January 1, 2017Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
340
Locations
2
Primary Endpoint
stone free rate (SFR)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

Arms & Interventions

Flexible ureteroscope

Experimental

Intervention: Retrograde Intrarenal Surgery (Procedure)

Outcomes

Primary Outcomes

stone free rate (SFR)

Time Frame: It will be assessed by non contrast computed tomography for the participants one month after the procedure

stone free rate after the procedure

Secondary Outcomes

  • Predictors of operative time of the procedure(Immediately after the procedure)
  • - Post-operative complications 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.(Post operative day 1 after the procedure)
  • - Patient -reported outcomes about post operative pain using visual analogue scale(within 3 months after the procedure)
  • 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)(within 3 months after the procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amr Abdel-Lateif El-Sawy

Principal Investigator

Mansoura University

Study Sites (2)

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