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Comparison of RIRS Versus PCNL Methods, According to Postoperative Pain and Analgesic Demand in 2 to 4 cm Renal Stones

Primary Purpose

Kidney Stones

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Percutaneous nephrolithotomy
Retrograde intrarenal surgery
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stones focused on measuring Stone, RIRs, PCNL, Pain

Eligibility Criteria

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

Inclusion Criteria:

  • The patients who have 2 to 4 cm kidney stones
  • ASA score within 1 to 3

Exclusion Criteria:

  • Previous surgical treatment including SWL
  • Congenital abnormalities

Sites / Locations

  • Diskapi TRHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

RIRS

PCNL

Arm Description

Retrograde intrarenal surgery

Percutaneous nephrolithotomy

Outcomes

Primary Outcome Measures

Analgesic demand
Stone clearance

Secondary Outcome Measures

Full Information

First Posted
April 22, 2015
Last Updated
April 29, 2015
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02430168
Brief Title
Comparison of RIRS Versus PCNL Methods, According to Postoperative Pain and Analgesic Demand in 2 to 4 cm Renal Stones
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
January 2017 (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
Purpose: to investigate the postoperative outcomes of Retrograde intrarenal surgery versus percutaneous nephrolithotomy in 2 to 4 cm kidney stones.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones
Keywords
Stone, RIRs, PCNL, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIRS
Arm Type
Active Comparator
Arm Description
Retrograde intrarenal surgery
Arm Title
PCNL
Arm Type
Active Comparator
Arm Description
Percutaneous nephrolithotomy
Intervention Type
Procedure
Intervention Name(s)
Percutaneous nephrolithotomy
Other Intervention Name(s)
PCNL
Intervention Type
Procedure
Intervention Name(s)
Retrograde intrarenal surgery
Other Intervention Name(s)
RIRS
Primary Outcome Measure Information:
Title
Analgesic demand
Time Frame
Postoperative 24 hours
Title
Stone clearance
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients who have 2 to 4 cm kidney stones ASA score within 1 to 3 Exclusion Criteria: Previous surgical treatment including SWL Congenital abnormalities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nihat Karakoyunlu
Phone
00905324747134
Email
nkarakoyunlu@gmail.com
Facility Information:
Facility Name
Diskapi TRH
City
Ankara
ZIP/Postal Code
06110
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nihat Karakoyunlu
Phone
00905324747134

12. IPD Sharing Statement

Citations:
PubMed Identifier
22093679
Citation
Akman T, Binbay M, Ozgor F, Ugurlu M, Tekinarslan E, Kezer C, Aslan R, Muslumanoglu AY. Comparison of percutaneous nephrolithotomy and retrograde flexible nephrolithotripsy for the management of 2-4 cm stones: a matched-pair analysis. BJU Int. 2012 May;109(9):1384-9. doi: 10.1111/j.1464-410X.2011.10691.x. Epub 2011 Oct 28.
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Comparison of RIRS Versus PCNL Methods, According to Postoperative Pain and Analgesic Demand in 2 to 4 cm Renal Stones

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