NCT03719456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

4.1 years

First QC Date

October 17, 2018

Last Update Submit

November 20, 2021

Conditions

Renal Stone

Keywords

Renal stoneCalculiRetrograde Intrarenal SurgeryFlexible ureteroscope

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Flexible ureteroscope

EXPERIMENTAL
Procedure: Retrograde Intrarenal Surgery

Interventions

Retrograde Intrarenal SurgeryPROCEDURE
Also known as: Flexible ureteroscope
Flexible ureteroscope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Urology and Nephrology Center

Al Mansurah, DK, 35516, Egypt

Location

Amr A Elsawy

Al Manşūrah, 35516, Egypt

Location

MeSH Terms

Conditions

NephrolithiasisCalculi

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Amr A Elsawy, MD

    Urology and Nephrology Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 25, 2018

Study Start

January 1, 2017

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations

EG(2)