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

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ClinicalTrials.gov Identifier: NCT04851171
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Ibrahim Alnadhari, Hamad Medical Corporation

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ureteric Stone Stone Ureter Procedure: Flexible Ureteroscopy Procedure: Semi-rigid Ureteroscopy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Semi-rigid Ureteroscopy and Flexible Ureteroscopy For the Treatment of Proximal Ureteric Stone
Actual Study Start Date : November 26, 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : January 2023
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851171


Contacts
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Contact: Ibrahim Alnadhari, MD, FRCS Uro +974-33403324/ +974-40115093 ibrahimah1978@yahoo.com, IAlnadhari@hamad.qa,
Contact: Omar Ali, MD +974- 55175719/ +974-40115441 omarisam1972@yahoo.com, oali@hamad.qa

Locations
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Qatar
Al Wakra Hospital Recruiting
Al-Wakrah, Doha, Qatar, 0000
Contact: Ibrahim Alnadhari, MD, FRCS Uro         
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
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Principal Investigator: Ibrahim Al-Nadhari Hamad Medical Corporation
More Information
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Publications:

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Responsible Party: Dr. Ibrahim Alnadhari, Associate Consultant- Surgery, Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT04851171    
Other Study ID Numbers: MRC-01-19-036
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Ibrahim Alnadhari, Hamad Medical Corporation:
Urolithiasis
Ureteroscopy
Ureteric stone
Flexible ureteroscopy
Semi-rigid ureteroscopy
Additional relevant MeSH terms:
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Ureteral Calculi
Ureterolithiasis
Calculi
Pathological Conditions, Anatomical
 Ureteral Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi