Comparing Efficacy and Complication Between Prone Versus... | NCT06624306

Studies
Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position for Percutaneous Nephrolithotomy (PCNL)

NCT06624306

Sponsor

Fayoum University Hospital

Status

Unknown status

Last Update Posted

Oct 2, 2024Actual

Enrollment

85Estimated

Phase

Not Applicable

Conditions

Urolithiasis
Kidney Stone
Complication

Interventions

Prone PNL
Prone-flexed PNL

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Actual

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Dec 1, 2024Estimated

First Submitted Date

Sep 24, 2024

First Submission Date that Met QC Criteria

Oct 1, 2024

First Posted Date

Oct 2, 2024Actual

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

Oct 1, 2024

Last Update Posted Date

Oct 2, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hesham Abdel Azim El Helaly, Assistant Professor, Fayoum University HospitalPrincipal Investigator

Lead Sponsor

Fayoum University HospitalOTHER

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)

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

85Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
prone PNL	Active Comparator	Prone PNL	Procedure: Prone PNL
prone-flexed PNL	Active Comparator	prone-flexed PNL	Procedure: Prone-flexed PNL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prone PNL	Procedure	Prone PNL	prone PNL
Prone-flexed PNL

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 of the two groups	Outcome measures by stone fragment residual ≤ 2 mm by computed tomography (CT)	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Staghorn calculi
Renal pelvis stones >2 cm
Lower pole stones >1.5 cm
SWL-resistant stones

Exclusion Criteria:

Age <18 years or Pregnancy
Bilateral simultaneous PCNL
Need for 3 percutaneous tracts intraoperative
Morbid obesity (BMI >40)
Non opaque renal stones.
Refuse to complete study requirements
Atypical bowel interposition need CT guided puncture
Tumour in the presumptive access tract area or Potential malignant kidney tumour

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fayoum faculty of Medicine		Al Fayyum	Faiyum Governorate	4558	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D052878	Urolithiasis
D007669	Kidney Calculi

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided