Endoscopic Guided PCNL Versus Standard PCNL | NCT04825353

Studies
Endoscopic Guided PCNL Versus Standard PCNL

NCT04825353

Sponsor

Benha University

Status

Unknown status

Last Update Posted

Jul 19, 2022Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Stones, Kidney

Interventions

Endoscopic compbined guided PCNL
Standard 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

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2019Actual

Primary Completion Date

Oct 1, 2022Estimated

Completion Date

Nov 1, 2022Estimated

First Submitted Date

Mar 25, 2021

First Submission Date that Met QC Criteria

Mar 30, 2021

First Posted Date

Apr 1, 2021Actual

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

Jul 17, 2022

Last Update Posted Date

Jul 19, 2022Actual

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

currently, percutaneous nephrolithotomy (PCNL) is the standard procedure of choice for management of large renal more than 2 cm.

the pivotal step in performing PCNL is creation of proper tract. this step can be done monitored under guidance of different modalities such as fluoroscopy, ultrasonography, endoscopy or combined in ECIRS, tract creation is controlled under endoscopic vision with a flexible ureteroscope .

Detailed Description

Aim: compare safety and efficacy and adverse events of ECIRS in comparison of standard fluoroscopic guided PCNL.

patients & methods: Patients will randomly be divided into two equal groups:

Group A: Patient will undergo ECIRS.

Group B: Patient will undergo standard PCNL

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

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ECIRS-Group	Experimental		Procedure: Endoscopic compbined guided PCNL
SPCNL-GRoup	Active Comparator		Procedure: Standard PCNL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic compbined guided PCNL	Procedure	patient undergo stone removal by ECIRS	ECIRS-Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stone Free Rate	If their is any residual stones	1day after operation.
Stone Free Rate	If their is any residual stones	1 months post operative
Stone Free Rate	If their is any residual stones	3 months post-operative

Secondary Outcomes

Measure	Description	Time Frame
operative time	the length of operation	intra oprative
blood loss	hemoglobin drop	pre-operative and 1 day post-oprative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with renal stones diameter of at least 2 cm.
American Society of Anesthesiology score ≤ 2.

Exclusion Criteria:

patients with renal anomalies.
transplanted kidney.
uncorrected coagulopathy.
active infection.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Waleed El-Shaer, M.D	Contact	01015767331	0020	waleed_elshaer@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Banha university hospital	Recruiting	Banhā	Qalyubia Governorate	13511	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

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Browse Branches

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