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Treatment of Upper Ureteric Stones

Primary Purpose

Ureteric Stones

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

SWL

Semirigid URS

Flexible URS

About this trial

This is an interventional treatment trial for Ureteric Stones focused on measuring ureteral stones, ureter, ureteroscopy, flexible, SWL

Eligibility Criteria

14 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Radio-opaque stones
less than or equal 1 cm

Exclusion Criteria:

Active UTI
Coagulopathy
Pregnancy
Ureteric stricture

Sites / Locations

Urology and Nephrology CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Extracorporeal Shockwaves

Semirigid URS

Flexible URS

Arm Description

Patients in this arm will undergo SWL

Patients in this arm will undergo Semirigid Ureteroscopy

Patients in this arm will undergo Flexible Ureteroscopy

Outcomes

Primary Outcome Measures

Stone free rate

The stone free rate will be evaluated with non-contrast CT

Secondary Outcome Measures

Complication rate

Complications will be classified according to modified Clavien Dindo

Full Information

NCT ID

NCT02469766

First Posted

June 9, 2015

Last Updated

August 28, 2016

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT02469766

Brief Title

Treatment of Upper Ureteric Stones

Official Title

A Comparison Between Flexible Ureteroscopy, Semirigid Ureteroscopy and Extracorporeal Shockwaves Lithotripsy (SWL) in The Management of Proximal Ureteric Stones. A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

August 2016 (Anticipated)

Study Completion Date

September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will be conducted to compare the success and complication rates of ureteroscopy, and shockwaves lithotripsy for treatment of upper ureteric stones ≤1 cm.

Detailed Description

This study will be conducted to compare the success and complication rates of Flexible, Semi-rigid URS, and SWL approaches for proximal ureteric stones with size ≤1 cm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ureteric Stones

Keywords

ureteral stones, ureter, ureteroscopy, flexible, SWL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Extracorporeal Shockwaves

Arm Type

Active Comparator

Arm Description

Patients in this arm will undergo SWL

Arm Title

Semirigid URS

Arm Type

Active Comparator

Arm Description

Patients in this arm will undergo Semirigid Ureteroscopy

Arm Title

Flexible URS

Arm Type

Active Comparator

Arm Description

Patients in this arm will undergo Flexible Ureteroscopy

Intervention Type

Procedure

Intervention Name(s)

SWL

Intervention Description

Patients in this arm will undergo SWL

Intervention Type

Procedure

Intervention Name(s)

Semirigid URS

Intervention Description

Patients in this arm will undergo semirigid URS

Intervention Type

Procedure

Intervention Name(s)

Flexible URS

Intervention Description

Patients in this arm will undergo Flexible URS

Primary Outcome Measure Information:

Title

Stone free rate

Description

The stone free rate will be evaluated with non-contrast CT

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Complication rate

Description

Complications will be classified according to modified Clavien Dindo

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Radio-opaque stones less than or equal 1 cm Exclusion Criteria: Active UTI Coagulopathy Pregnancy Ureteric stricture

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Muhamad M abdallateef, MD

Phone

01009681644

seif_1901@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed R EL-Nahas, MD

Phone

+20502202222

Ext

1699

ar_el_nahas@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed M Shoma, MD

Organizational Affiliation

Mansoura University

Official's Role

Study Chair

Facility Information:

Facility Name

Urology and Nephrology Center

City

Mansoura

State/Province

Dakhlia

ZIP/Postal Code

35516

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Muhammad M abdallateef, MD

Phone

01009681644

seif_1901@yahoo.com

First Name & Middle Initial & Last Name & Degree

Ahmed R EL-Nahas, MD

Phone

+20502202222

Ext

1699

ar_el_nahas@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Treatment of Upper Ureteric Stones

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