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

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

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

Study Overview

• Status: Unknown
• Conditions: Complication of Surgical Procedure; Prone Position; Percutaneous Nephrolithotomy (PCNL); Prone-Flexed Position
• Intervention / Treatment: Procedure: Prone-Flexed PCNL; Procedure: Prone PCNL

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aldakahlia
    • Mansoura, Aldakahlia, Egypt, 35516
      • Urology and nephrology center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Prone-Flexed PCNL; Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)	Procedure: Prone-Flexed PCNL; Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL); Other Names: Prone-Flexed Percutaneous Nephrolithotomy
ACTIVE_COMPARATOR: Prone PCNL; Prone Position For Percutaneous Nephrolithotomy (PCNL)	Procedure: Prone PCNL; Prone Position For Percutaneous Nephrolithotomy (PCNL); Other Names: Prone Percutaneous Nephrolithotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing the prone with the prone-flexed position for PCNL reporting complications	Outcome measures by using the clavien dindo classification system	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of stone free rate (SFR) of the two groups	Outcome measures by stone fragment residual ≤ 2 mm by computed tomography (CT)	1 year
Asses the easiness of accessibility of the targeted stone	Outcome measures by counting number and site of puncture trial	1 year

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Ahmed Shoma, MD, Urology and nephrology center; Study Director: Ahmed Elassmy, MD, Urology and nephrology center; Principal Investigator: Mohamed Zahran, MD, Urology and nephrology center; Principal Investigator: Hossam Nabeeh, Msc, Urology and nephrology center; Principal Investigator: Mohamed Abdulatif, Msc, Urology and nephrology center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2017
• Primary Completion (ANTICIPATED): July 1, 2018
• Study Completion (ANTICIPATED): July 1, 2018

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (ACTUAL): May 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2017
• Last Update Submitted That Met QC Criteria: June 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Prone-Flexed Position; Percutaneous Nephrolithotomy (PCNL); Clavien-Dindo Classification Score
• Other Study ID Numbers: F-Prone PNL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: meta-analyses by contact the Prof. Ahmed Shoma, MD, Phd (Study Chair)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No