NCT05953571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

July 11, 2023

Last Update Submit

July 18, 2023

Conditions

Uretro-pelvic Junction ObstructionPoorly Function Kidney

Keywords

UPJOPoorly function kidneyLaparoscopic assissted pyeloplastyOpen pyeloplastyPediatrics

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • operative time

    one month

Study Arms (2)

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

Dismembered PyeloplastyPROCEDURE

dismembered Anderson-Hynes repair was performed using 5/0 absorbable suture.

Group BGroupA

Eligibility Criteria

Age2 Months - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammad Daboos

Cairo, Select, 115678, Egypt

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Surgery Department, Al-Azhar University.

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 20, 2023

Study Start

January 8, 2022

Primary Completion

March 8, 2023

Study Completion

June 30, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

EG(1)