Skip to main content
OpenTrials
Completed

NCT Number: NCT03719456

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology and Nephrology Center, Al Mansurah, DK, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retrograde Intrarenal Surgery

Procedure

Other names: Flexible ureteroscope

Primary outcomes

  1. 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

  1. Predictors of operative time of the procedure

    Time frame: Immediately after the procedure

    Predictors of operative time of the procedure

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

    Time frame: within 30 days after the procedure

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

  3. 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.

    Time frame: Post operative day 1 after the procedure

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

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

    Time frame: 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.

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

    Time frame: within 3 months after the procedure

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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 25, 2018
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.