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

NCT03147950 | Unknown DMC

• 1 other identifier: F-Prone PNL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Percutaneous Nephrolithotomy (PCNL); Prone Position; Prone-Flexed Position; Complication of Surgical Procedure

Keywords

Prone-Flexed Position; Percutaneous Nephrolithotomy (PCNL); Clavien-Dindo Classification Score

Outcome Measures

Primary Outcomes (1)

• Comparing the prone with the prone-flexed position for PCNL reporting complications

  Outcome measures by using the clavien dindo classification system

  1 year

Secondary Outcomes (2)

• Assessment of stone free rate (SFR) of the two groups

  1 year

• Asses the easiness of accessibility of the targeted stone

  1 year

Study Arms (2)

Prone-Flexed PCNL

ACTIVE COMPARATOR

Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)

Procedure: Prone-Flexed PCNL

Prone PCNL

ACTIVE COMPARATOR

Prone Position For Percutaneous Nephrolithotomy (PCNL)

Procedure: Prone PCNL

Interventions

Prone-Flexed PCNL PROCEDURE

Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)

Also known as: Prone-Flexed Percutaneous Nephrolithotomy

Prone-Flexed PCNL

Prone PCNL PROCEDURE

Prone Position For Percutaneous Nephrolithotomy (PCNL)

Also known as: Prone Percutaneous Nephrolithotomy

Prone PCNL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Large renal pelvic stone
• Upper calyceal stone
• Middle calyceal stone

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

Study Officials

• Ahmed Shoma, MD

  Urology and Nephrology center

  STUDY CHAIR

• Ahmed Elassmy, MD

  Urology and Nephrology center

  STUDY DIRECTOR

• Nasr Eltabey, MD

  Urology and Nephrology center

  STUDY DIRECTOR

• Mohamed Zahran, MD

  Urology and Nephrology center

  PRINCIPAL INVESTIGATOR

• Mahmoud Laimon, MSc

  Urology and Nephrology center

  PRINCIPAL INVESTIGATOR

• Hossam Nabeeh, Msc

  Urology and Nephrology center

  PRINCIPAL INVESTIGATOR

• Mohamed Abdulatif, Msc

  Urology and Nephrology center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelwahab R. Hashem, Msc

CONTACT

01069678979; abdelwahab_hashem@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: June 7, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)