NCT07026721

Brief Summary

Several studies have investigated the use of scoring systems for predicting stone-free rates after RIRS. Previous research has evaluated the RIRS Scoring System, RUSS, and other similar systems in different patient populations. This study was conducted to compare RIRS scoring system and Resorlu Unsal Stone Score (RUSS) for predicting stone free rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
Last Updated

June 18, 2025

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

June 3, 2025

Last Update Submit

June 10, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Correlation between the RIRS Scoring System and stone-free rate after Retrograde Intrarenal Surgery (RIRS), assessed using CT KUB

    12 months

  • Correlation between the Resorlu-Unsal Stone Score (RUSS) and stone-free rate after Retrograde Intrarenal Surgery (RIRS), assessed using CT KUB

    12 months

Secondary Outcomes (2)

  • Stone Burden as a Predictor of Stone-Free Rate After RIRS

    Preoperative assessment and 1 month postoperatively for stone-free status

  • Stone Density as a Predictor of Stone-Free Rate After RIRS

    Preoperative assessment and 1 month postoperatively for stone-free status

Interventions

The intervention involves Retrograde Intrarenal Surgery (RIRS) performed using a flexible ureteroscope to access the renal collecting system via a retrograde (urethra → bladder → ureter → kidney) approach. Stones are fragmented using a holmium:YAG laser, with or without the use of a ureteral access sheath, depending on the case. What distinguishes this intervention from others is the integration of preoperative scoring systems-specifically the RIRS Scoring System and the Resorlu Unsal Stone Score (RUSS)-to predict stone-free outcomes and guide case selection and surgical planning. Additionally, all procedures are performed by experienced endourologists following a standardized protocol, including consistent patient positioning, anesthesia, access technique, and post-operative imaging at defined intervals to assess outcomes.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patients with renal calculi undergoing RIRS.

You may qualify if:

  • patients more than 18 years of age undergoing RIRS for renal stone
  • providing informed written consent

You may not qualify if:

  • Previous renal and ureteric surgeries
  • coexisting bladder, ureteral stone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital (TUTH), Maharajgunj, Kathmandu, Nepal

Kathmandu, Bagmati, 44600, Nepal

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Study Officials

  • Saro Prajapati, MBBS, MS

    Department of General Surgery Maharajgunj Medical Campus Institute of Medicine, Tribhuvan University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 3, 2025

First Posted

June 18, 2025

Study Start

January 1, 2024

Primary Completion

December 27, 2024

Study Completion

December 29, 2024

Last Updated

June 18, 2025

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations