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

NCT ID: NCT03147950

Last Updated: 2017-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-07-01

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Prone-Flexed PCNL

Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)

Group Type ACTIVE_COMPARATOR

Prone-Flexed PCNL

Intervention Type PROCEDURE

Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)

Prone PCNL

Prone Position For Percutaneous Nephrolithotomy (PCNL)

Group Type ACTIVE_COMPARATOR

Prone PCNL

Intervention Type PROCEDURE

Prone Position For Percutaneous Nephrolithotomy (PCNL)

Interventions

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Prone-Flexed PCNL

Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)

Intervention Type PROCEDURE

Prone PCNL

Prone Position For Percutaneous Nephrolithotomy (PCNL)

Intervention Type PROCEDURE

Other Intervention Names

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Prone-Flexed Percutaneous Nephrolithotomy Prone Percutaneous Nephrolithotomy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Abdelwahab Hashem

Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Shoma, MD

Role: STUDY_CHAIR

Urology and Nephrology center

Ahmed Elassmy, MD

Role: STUDY_DIRECTOR

Urology and Nephrology center

Nasr Eltabey, MD

Role: STUDY_DIRECTOR

Urology and Nephrology center

Mohamed Zahran, MD

Role: PRINCIPAL_INVESTIGATOR

Urology and Nephrology center

Mahmoud Laimon, MSc

Role: PRINCIPAL_INVESTIGATOR

Urology and Nephrology center

Hossam Nabeeh, Msc

Role: PRINCIPAL_INVESTIGATOR

Urology and Nephrology center

Mohamed Abdulatif, Msc

Role: PRINCIPAL_INVESTIGATOR

Urology and Nephrology center

Locations

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Urology and Nephrology Center

Al Mansurah, Aldakahlia, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Abdelwahab R. Hashem, Msc

Role: CONTACT

01069678979 ext. 002

Other Identifiers

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F-Prone PNL

Identifier Type: -

Identifier Source: org_study_id

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