Back to resultsIs There Any Relation Between Pain and Stone Location in Retrograde Intrarenal Surgery?
Primary Purpose
Nephrolithiasis
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Retrograde Intrarenal Surgery
Sponsored by
About this trial
This is an interventional screening trial for Nephrolithiasis focused on measuring pain, RIRS, kidney
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing RIRS Age between 18 and 90 years
Exclusion Criteria:
- Patients who have congenital urogenital abnormalities 2)Patients who have previous surgery history
Sites / Locations
- Dıskapı TRHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
first group
second group
third group
forth group
fifth group
Arm Description
patients who have upper pole kidney stones treated with flexible renoscopy
patients u who have mid pole kidney stones treated with flexible renoscopy
patients who have lower pole kidney stones treated with flexible renoscopy
patients who have kidney stones in pelvis treated with flexible renoscopy
patients who have multiple calixes kidney stones treated with flexible renoscopy
Outcomes
Primary Outcome Measures
Pain degree
Secondary Outcome Measures
Full Information
NCT ID
NCT02430883
First Posted
April 27, 2015
Last Updated
April 27, 2015
Sponsor
Diskapi Teaching and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02430883
Brief Title
Is There Any Relation Between Pain and Stone Location in Retrograde Intrarenal Surgery?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We want to serach the relationship between the pain degree and stone localisation in kidney in Retrograde intrarenal surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis
Keywords
pain, RIRS, kidney
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
first group
Arm Type
Active Comparator
Arm Description
patients who have upper pole kidney stones treated with flexible renoscopy
Arm Title
second group
Arm Type
Active Comparator
Arm Description
patients u who have mid pole kidney stones treated with flexible renoscopy
Arm Title
third group
Arm Type
Active Comparator
Arm Description
patients who have lower pole kidney stones treated with flexible renoscopy
Arm Title
forth group
Arm Type
Active Comparator
Arm Description
patients who have kidney stones in pelvis treated with flexible renoscopy
Arm Title
fifth group
Arm Type
Active Comparator
Arm Description
patients who have multiple calixes kidney stones treated with flexible renoscopy
Intervention Type
Procedure
Intervention Name(s)
Retrograde Intrarenal Surgery
Intervention Description
endoscopic treatment of kidney stones with flexible renoscopy
Primary Outcome Measure Information:
Title
Pain degree
Time Frame
Pain degree postoperative 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing RIRS Age between 18 and 90 years
Exclusion Criteria:
Patients who have congenital urogenital abnormalities 2)Patients who have previous surgery history
Facility Information:
Facility Name
Dıskapı TRH
City
Ankara
ZIP/Postal Code
06110
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nihat Karakoyunlu, MD
Phone
00905324747134
Email
nkarakoyunlu@gmail.com
First Name & Middle Initial & Last Name & Degree
Nihat Karakoyunlu, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
19901004
Citation
Polito C, La Manna A, Signoriello G, Marte A. Recurrent abdominal pain in childhood urolithiasis. Pediatrics. 2009 Dec;124(6):e1088-94. doi: 10.1542/peds.2009-0825. Epub 2009 Nov 9.
Results Reference
result
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Is There Any Relation Between Pain and Stone Location in Retrograde Intrarenal Surgery?
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