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NCT Number: NCT06660914

Robotic Flexible Ureteroscopy Versus Standard Flexible Ureteroscopy for Renal Stones

This is a prospective randomized clinical trial which aims to compare the clinical outcomes of robotic flexible ureteroscopy and standard flexible ureteroscopy for the treatment of renal stones.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North District Hospital

Sheung Shui, Hong Kong

Location status: Recruiting

Location contact

Chi Fai NG, MD

CONTACT

[email protected]

35052625

Steffi Kar Kei YUEN, FRCS

SUB_INVESTIGATOR

About this study

This is a prospective randomized controlled trial comparing robotic flexible ureteroscopy and standard flexible ureteroscopy for patients with treatment of renal stones. All consecutive patients who are scheduled for flexible ureteroscopy for treatment of renal stones would be screened for study eligibility. Patients are randomised to receive either robotic or standard flexible ureteroscopy with an allocation ratio of 1:1. by computer generated random block. The urologist performing the surgery could not be blinded due to the nature of the intervention. Patients receiving the treatment and investigators assessing for any disease recurrence are blinded from the allocated treatment arm.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years old with informed consent
  • Being willing and able to provide written informed consent

Exclusion criteria

  • Patients with abnormal urinary tract (e.g. ileal conduit, neobladder, ureteric stricture)
  • American Society of Anesthesiologists (ASA) physical status classification system >3
  • Untreated urinary tract infection
  • Renal stones > 3cm in diameter

Treatment and study plan

flexible ureteroscopy

Procedure

Ureteroscopic lithotripsy

Primary outcomes

  1. Stone-free rate at 1 month

    Time frame: Month 1

    Stone-free rate at 1 month is defined by non contrast computer tomography (NCCT) performed within 24 hours of surgery without residual stone fragments or residual stone fragments <2mm

Secondary outcomes

  1. Stone-free rate at 3 month

    Time frame: Month 3

    If not stone free at 1 month, stone-free rate at 3 month is defined by non contrast computer tomography (NCCT) performed within 24 hours of surgery without residual stone fragments or residual stone fragments <2mm

  2. Operative time

    Time frame: During operation

    the time from insertion of an endoscope into the urethra to the completion of stent placement

  3. Lasing Time

    Time frame: During operation

    The total lasing time in minutes during operation

  4. Total laser energy used

    Time frame: During operation

    Total laser energy used during operation

  5. Total radiation dose

    Time frame: During operation

    Total radiation dose during operation

  6. Total radiation time

    Time frame: during operation

    total radiation time in minutes during operation

  7. Length of hospital stay

    Time frame: On Discharge

    defined from the day of surgery to the day of discharge, counted in days.

  8. Postoperative pain

    Time frame: Baseline, Week 1 and Week 12

    By visual analogue scores from 0-10, the highest score the more pain.

  9. Surgeon radiation exposure

    Time frame: During operation

    By radiation dosimeter

Study contacts

Contact information is provided by the study sponsor or research team.

Steffi Kar Kei YUEN, FRCS-Surgery

CONTACT

[email protected]

35052625

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing Robotic Flexible Ureteroscopy With Standard Flexible Ureteroscopy for Treatment of Renal Stones - A Pilot Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 28, 2024
Registry last updated
May 6, 2025

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.

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