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

Primary Purpose

Ureteric Stone, Stone Ureter

Status
Unknown status
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Flexible Ureteroscopy
Semi-rigid Ureteroscopy
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureteric Stone focused on measuring Urolithiasis, Ureteroscopy, Ureteric stone, Flexible ureteroscopy, Semi-rigid ureteroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Al Wakra HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Semi-rigid Ureteroscopy

Flexible Ureteroscopy

Arm Description

Patient with upper ureteric stone who are randomized in this arm will undergo semi-rigid ureteroscopy for treatment of the stone.

Patient with upper ureteric stone who are randomized in this arm will undergo flexible ureteroscopy for treatment of the stone.

Outcomes

Primary Outcome Measures

Stone free rate
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

Complication rate
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.
To compare stone free rate and complications between patients with ureteric stent and patients without ureteric stent
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.

Full Information

First Posted
April 1, 2021
Last Updated
April 14, 2021
Sponsor
Hamad Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04851171
Brief Title
Semi-rigid Ureteroscopy Versus Flexible Ureteroscopy For the Treatment of Proximal Ureteric Stone
Official Title
A Randomized Controlled Trial Comparing Semi-rigid Ureteroscopy and Flexible Ureteroscopy For the Treatment of Proximal Ureteric Stone
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 26, 2020 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamad Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteric Stone, Stone Ureter
Keywords
Urolithiasis, Ureteroscopy, Ureteric stone, Flexible ureteroscopy, Semi-rigid ureteroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Semi-rigid Ureteroscopy
Arm Type
Active Comparator
Arm Description
Patient with upper ureteric stone who are randomized in this arm will undergo semi-rigid ureteroscopy for treatment of the stone.
Arm Title
Flexible Ureteroscopy
Arm Type
Active Comparator
Arm Description
Patient with upper ureteric stone who are randomized in this arm will undergo flexible ureteroscopy for treatment of the stone.
Intervention Type
Procedure
Intervention Name(s)
Flexible Ureteroscopy
Intervention Description
Flexible ureteroscopy is the use of flexible ureteroscope for the treatment of stone in the upper ureter with the aid of laser lithotripsy.
Intervention Type
Procedure
Intervention Name(s)
Semi-rigid Ureteroscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stone free rate
Description
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).
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Complication rate
Description
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.
Time Frame
Three Months
Title
To compare stone free rate and complications between patients with ureteric stent and patients without ureteric stent
Description
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.
Time Frame
Three Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim Alnadhari, MD, FRCS Uro
Phone
+974-33403324/ +974-40115093
Email
ibrahimah1978@yahoo.com, IAlnadhari@hamad.qa,
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Ali, MD
Phone
+974- 55175719/ +974-40115441
Email
omarisam1972@yahoo.com, oali@hamad.qa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahim Al-Nadhari
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al Wakra Hospital
City
Al-Wakrah
State/Province
Doha
ZIP/Postal Code
0000
Country
Qatar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim Alnadhari, MD, FRCS Uro

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17678991
Citation
Wolf JS Jr. Treatment selection and outcomes: ureteral calculi. Urol Clin North Am. 2007 Aug;34(3):421-30. doi: 10.1016/j.ucl.2007.04.010.
Results Reference
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PubMed Identifier
21165201
Citation
Lee JH, Woo SH, Kim ET, Kim DK, Park J. Comparison of Patient Satisfaction with Treatment Outcomes between Ureteroscopy and Shock Wave Lithotripsy for Proximal Ureteral Stones. Korean J Urol. 2010 Nov;51(11):788-93. doi: 10.4111/kju.2010.51.11.788. Epub 2010 Nov 17.
Results Reference
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PubMed Identifier
27238615
Citation
Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART II. J Urol. 2016 Oct;196(4):1161-9. doi: 10.1016/j.juro.2016.05.091. Epub 2016 May 27.
Results Reference
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PubMed Identifier
25014576
Citation
Hyams ES, Monga M, Pearle MS, Antonelli JA, Semins MJ, Assimos DG, Lingeman JE, Pais VM Jr, Preminger GM, Lipkin ME, Eisner BH, Shah O, Sur RL, Mufarrij PW, Matlaga BR. A prospective, multi-institutional study of flexible ureteroscopy for proximal ureteral stones smaller than 2 cm. J Urol. 2015 Jan;193(1):165-9. doi: 10.1016/j.juro.2014.07.002. Epub 2014 Jul 9.
Results Reference
background
PubMed Identifier
26617636
Citation
Alkan E, Saribacak A, Ozkanli AO, Basar MM, Acar O, Balbay MD. Flexible Ureteroscopy Can Be More Efficacious in the Treatment of Proximal Ureteral Stones in Select Patients. Adv Urol. 2015;2015:416031. doi: 10.1155/2015/416031. Epub 2015 Nov 4.
Results Reference
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PubMed Identifier
27622276
Citation
Galal EM, Anwar AZ, El-Bab TK, Abdelhamid AM. Retrospective comparative study of rigid and flexible ureteroscopy for treatment of proximal ureteral stones. Int Braz J Urol. 2016 Sep-Oct;42(5):967-972. doi: 10.1590/S1677-5538.IBJU.2015.0644.
Results Reference
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PubMed Identifier
25361706
Citation
Karadag MA, Demir A, Cecen K, Bagcioglu M, Kocaaslan R, Altunrende F. Flexible ureterorenoscopy versus semirigid ureteroscopy for the treatment of proximal ureteral stones: a retrospective comparative analysis of 124 patients. Urol J. 2014 Nov 1;11(5):1867-72. Erratum In: Urol J. 2015 Jul-Aug;12(4):2294. Sofikerim, Mustafa [Deleted].
Results Reference
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Semi-rigid Ureteroscopy Versus Flexible Ureteroscopy For the Treatment of Proximal Ureteric Stone

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