Laparoscopic Assisted Dismembered Pyeloplasty Versus Open... | NCT05953571

Studies
Laparoscopic Assisted Dismembered Pyeloplasty Versus Open Pyeloplasty in (UPJO) With Poorly Function Kidney in Pediatrics

NCT05953571

Sponsor

Al-Azhar University

Status

Completed

Last Update Posted

Jul 20, 2023Actual

Enrollment

65Actual

Phase

Not provided

Conditions

Uretro-pelvic Junction Obstruction
Poorly Function Kidney

Interventions

Dismembered Pyeloplasty

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 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2022Actual

Primary Completion Date

Mar 8, 2023Actual

Completion Date

Jun 30, 2023Actual

First Submitted Date

Jul 11, 2023

First Submission Date that Met QC Criteria

Jul 18, 2023

First Posted Date

Jul 20, 2023Actual

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 18, 2023

Last Update Posted Date

Jul 20, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohammad Daboos, Pediatric Surgery Department, Al-Azhar University., Al-Azhar UniversityPrincipal Investigator

Lead Sponsor

Al-Azhar UniversityOTHER

Collaborators

Name	Class
University Hospital Fattouma Bourguiba	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The management of kidneys with poor function less than 10% has been the subject of debate for more than a decade. Some authors have recommended nephrectomy while others favor renal salvage (pyeloplasty). the investigators reported their experience of lap assisted pyeloplasty in poorly functioning kidneys in the pediatric age group, concerning on the benefits of a minimally invasive method for repair of UPJO, in comparison with open approach.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GroupA		Laparoscopic assisted dismembered pyeloplasty in poorly function kidney	Procedure: Dismembered Pyeloplasty
Group B		Open dismembered pyeloplasty in poorly function kidney	Procedure: Dismembered Pyeloplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dismembered Pyeloplasty	Procedure	dismembered Anderson-Hynes repair was performed using 5/0 absorbable suture.	Group B GroupA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Renal function	Split renal function by Renal scan (DTPA) %	12 months post-operative
Measurments A-P renal pelvis diameter	ultrasound measuerment of renal pelvis diameter by mm	12 months

Secondary Outcomes

Measure	Description	Time Frame
operative time	operative time by minutes	one month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with hydronephrosis diagnosed as UPJO
Antero-Posterior pelvic diameter more than 20 mm
renal function equal or less than 10%,
corrected by laparoscopic assisted or open pyeloplasty

Exclusion Criteria:

Patients with ureteral dilatation (VUR),
renal function more than 10%,
acquired and recurrent cases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

14 Years

Standard Ages

Child

Study Population

Children suffered from Uretro-pelvic junction obstruction with split renal function less than 10%

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mohammad Daboos		Cairo	Select	115678	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