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NCT03147950 Clinical Trial

Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)

Complication of Surgical Procedure Clinical Trial

Official title:
Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL) Comparing Efficacy and Complication According to Clavien-Dindo Classification Score Randomised Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03147950
Other study ID # F-Prone PNL
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 8, 2017
Last updated June 5, 2017
Start date July 1, 2017
Est. completion date July 1, 2018

Study information
Verified date May 2017
Source Mansoura University
Contact Abdelwahab R. Hashem, Msc
Phone 01069678979
Email abdelwahab_hashem@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

compare the prone with the prone-flexed position accessibility of upper and middle calyceal approach by subcostal puncture and PCNL reporting complications using the Clavien-Dindo system with Categorisation of PCNL-specific complications according to Clavien-Dindo classification score

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date July 1, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Large renal pelvic stone

- Upper calyceal stone

- Middle calyceal stone

Exclusion Criteria:

- lower calyceal stone

- Bilateral simultaneous PCNL

- Need for 3 percutaneous tracts intraoperative

- Morbid obesity (BMI >40)

- Non opaque renal stones.

- Refuse to complete study requirements

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Prone-Flexed PCNL
Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)
• Prone PCNL
Prone Position For Percutaneous Nephrolithotomy (PCNL)

Locations
Country Name City State
Egypt Urology and Nephrology Center Mansoura Aldakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparing the prone with the prone-flexed position for PCNL reporting complications Outcome measures by using the clavien dindo classification system 1 year
Secondary Assessment of stone free rate (SFR) of the two groups Outcome measures by stone fragment residual = 2 mm by computed tomography (CT) 1 year
Secondary Asses the easiness of accessibility of the targeted stone Outcome measures by counting number and site of puncture trial 1 year
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