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NCT02430168 Clinical Trial

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

Kidney Stones Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02430168
Other study ID # 2-4 cm RIRS vs PCNL
Secondary ID
Status Recruiting
Phase Phase 4
First received April 22, 2015
Last updated April 29, 2015
Start date December 2014
Est. completion date January 2017

Study information
Verified date April 2015
Source Diskapi Teaching and Research Hospital
Contact Nihat Karakoyunlu
Phone 00905324747134
Email nkarakoyunlu@gmail.com
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date January 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Percutaneous nephrolithotomy

• Retrograde intrarenal surgery

Locations
Country Name City State
Turkey Diskapi TRH Ankara

Sponsors (1)
Lead Sponsor Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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;10 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Analgesic demand Postoperative 24 hours Yes
Primary Stone clearance 3 months No
See also
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Completed NCT03095885 - A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria N/A
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Completed NCT01088555 - Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers N/A
Recruiting NCT00489723 - Is There is a Role of Prophylactic Therapy With Tamsulosin Before Extracorporeal Shock Wave Lithotripsy to Avoid Development of Steinstrasse ? N/A
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Enrolling by invitation NCT02408211 - Preoperative Antibiotic PNL Study Phase 4
Withdrawn NCT01560091 - Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy Phase 3