Prone Versus Prone-Flexed Position For Percutaneous Nephr... | NCT03147950

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

NCT03147950

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Jun 7, 2017Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

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

Interventions

Prone-Flexed PCNL
Prone PCNL

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Estimated

Primary Completion Date

Jul 1, 2018Estimated

Completion Date

Jul 1, 2018Estimated

First Submitted Date

May 8, 2017

First Submission Date that Met QC Criteria

May 8, 2017

First Posted Date

May 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2017

Last Update Posted Date

Jun 7, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abdelwahab Hashem, Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator, Mansoura UniversityPrincipal Investigator

Lead Sponsor

Mansoura UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Prone-Flexed PCNL	Procedure	Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)	Prone-Flexed PCNL

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abdelwahab R. Hashem, Msc	Contact	01069678979	002	abdelwahab_hashem@yahoo.com

Overall Officials

Name	Affiliation	Role
Ahmed Shoma, MD	Urology and Nephrology center	Study Chair
Ahmed Elassmy, MD	Urology and Nephrology center	Study Director
Nasr Eltabey, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Urology and Nephrology Center		Al Mansurah	Aldakahlia	35516	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

meta-analyses by contact the Prof. Ahmed Shoma, MD, Phd (Study Chair)

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided