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

Sponsor
Diskapi Teaching and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02430168
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
25
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Purpose: to investigate the postoperative outcomes of Retrograde intrarenal surgery versus percutaneous nephrolithotomy in 2 to 4 cm kidney stones.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Percutaneous nephrolithotomy
  • Procedure: Retrograde intrarenal surgery
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Study Start Date :
Dec 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Jan 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: RIRS

Retrograde intrarenal surgery

Procedure: Retrograde intrarenal surgery
Other Names:
  • RIRS

    		•
    Active Comparator: PCNL

    Percutaneous nephrolithotomy

    Procedure: Percutaneous nephrolithotomy
    Other Names:
  • PCNL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Analgesic demand [Postoperative 24 hours]

    2. Stone clearance [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Diskapi TRH Ankara Turkey 06110

    Sponsors and Collaborators

    • Diskapi Teaching and Research Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nihat Karakoyunlu, MD, Diskapi Teaching and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT02430168
    Other Study ID Numbers:
    • 2-4 cm RIRS vs PCNL
    First Posted:
    Apr 30, 2015
    Last Update Posted:
    Apr 30, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Nihat Karakoyunlu, MD, Diskapi Teaching and Research Hospital
    Stone
    RIRs
    PCNL
    Pain
    Additional relevant MeSH terms:
    Kidney Calculi

    Study Results

    No Results Posted as of Apr 30, 2015