Semi-rigid Ureteroscopy Versus Flexible Ureteroscopy For the Treatment of Proximal Ureteric Stone

April 14, 2021 updated by: Dr. Ibrahim Alnadhari, Hamad Medical Corporation

A Randomized Controlled Trial Comparing Semi-rigid Ureteroscopy and Flexible Ureteroscopy For the Treatment of Proximal Ureteric Stone

The present study is randomized in nature, comparing the stone free rate and complications rate between semi-rigid ureteroscopy (SR-URS) and Flexible Ureteroscopy (F-URS) for the treatment of Proximal Ureteric stone (PUS), whereby the preoperative assessments, procedure and reporting of outcomes will all be standardized.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There are various treatment options that can be used for the treatment of PUS, which include extracorporeal shockwave lithotripsy (SWL), ureteroscopy (URS), percutaneous nephrolithotomy (PCNL), antegrade uretero-lithotripsy, laparoscopy, and rarely, open surgical procedures. However, the standard, and the most frequently used modalities are SWL and ureteroscopy. When comparing the effectiveness in the treatment of Proximal Ureteric stone (PUS) between SWL and URS, SWL has lower rates of complication and morbidity, but URS has a higher likelihood of successfully treating the patient within a single procedure. Additionally, with the advancements in technology and miniaturization of the ureteroscopes, along with the presence of auxiliary instruments such as holmium laser and retrieval baskets, ureteroscopy is more widely used.

In the proximal ureter, SR-URS tends to encounter difficulties in accessing the stone, but F-URS aids in overcoming those difficulties. As a result, the use of F-URS for PUS has indicated a strong success rate with lower likelihood of complications. When comparing the drawbacks of the two types of modalities, F-URS tends to be more expensive, and requires auxiliary instruments. And SR-URS tends to have lower success rate along with an increased rate in complications.

The precedence of FURS over SR-URS in the treatment of PUS is yet to be extensively studied. Presently there are only five studies that have compared the two modalities of treatment. But, due to the lack standardization of variables, procedure, follow-up imaging and reporting of outcomes in the past studies, it is imperative to conduct study that is prospective and randomized in nature.

The present study is randomized in nature, comparing the stone free rate and complications rate between SR-URS and F-URS for the treatment of PUS, whereby the preoperative assessments, procedure and reporting of outcomes will all be standardized.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Qatar
    • Doha
      • Al-Wakrah, Doha, Qatar, 0000
        • Recruiting
        • Al Wakra Hospital
        • Contact:
          • Ibrahim Alnadhari, MD, FRCS Uro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Single proximal ureteric stone indicated for active treatment with ureteroscopy (stented or non-stented)

Exclusion Criteria:

  • Solitary Kidney
  • Bilateral ureteric stones
  • Ipsilateral multiple simultaneous ureteric stones
  • Ipsilateral kidney stone
  • Active UTI
  • Coagulopathy diseases
  • Ipsilateral ureteral anomalies, ureteral disorder (tumor or stricture) or previous ureteral open surgery.
  • Pregnant patients.
  • Unable to give informed consent.
  • Patient is not agreeing to go through the randomization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Semi-rigid Ureteroscopy
Patient with upper ureteric stone who are randomized in this arm will undergo semi-rigid ureteroscopy for treatment of the stone.
Procedure: Semi-rigid Ureteroscopy
Semi-rigid ureteroscopy is the use of the semi-rigid ureteroscope for the treatment of stone in the upper ureter with the aid of laser lithotripsy.
Active Comparator: Flexible Ureteroscopy
Patient with upper ureteric stone who are randomized in this arm will undergo flexible ureteroscopy for treatment of the stone.
Procedure: Flexible Ureteroscopy
Flexible ureteroscopy is the use of flexible ureteroscope for the treatment of stone in the upper ureter with the aid of laser lithotripsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone free rate
Time Frame: Four weeks
Sone free status will be assessed by doing CT KUB scan 4 weeks postoperative and it is defined as patients with no residual stones or clinically insignificant residual fragments (< 2 mm).
Four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: Three Months
To evaluate the complication rate post procedure including infection rate, genitourinary injury, hematuria, emergency visits rate and we will use of modified Calvin Dindo classification to grade the surgical complications.
Three Months
To compare stone free rate and complications between patients with ureteric stent and patients without ureteric stent
Time Frame: Three Months
Patients will be stratified into two groups: group 1 with ureteric stents and group 2 without ureteric stents. Then comparison between the two groups in regards the stone free rate and the complications rate as per the previous definitions.
Three Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamad Medical Corporation

Investigators

  • Principal Investigator: Ibrahim Al-Nadhari, Hamad Medical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2020

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

April 1, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 20, 2021

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-01-19-036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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