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

• Sponsor: Al-Azhar University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05953571
• Collaborator: University Hospital Fattouma Bourguiba (Other)
• Enrollment: 65
• Location: 1
• Actual Duration (Months): 17.7
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uretro-pelvic Junction Obstruction; Poorly Function Kidney	Procedure: Dismembered Pyeloplasty

Study Design

• Study Type: Observational
• Actual Enrollment: 65 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Laparoscopic Assisted Dismembered Pyeloplasty Versus Open Pyeloplasty in (UPJO) With Poorly Function Kidney in Pediatrics
• Actual Study Start Date: Jan 8, 2022
• Actual Primary Completion Date: Mar 8, 2023
• Actual Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
GroupA Laparoscopic assisted dismembered pyeloplasty in poorly function kidney	Procedure: Dismembered Pyeloplasty; dismembered Anderson-Hynes repair was performed using 5/0 absorbable suture.
Group B Open dismembered pyeloplasty in poorly function kidney	Procedure: Dismembered Pyeloplasty; dismembered Anderson-Hynes repair was performed using 5/0 absorbable suture.

Outcome Measures

Primary Outcome Measures

1. Renal function [12 months post-operative]

   Split renal function by Renal scan (DTPA) %

2. Measurments A-P renal pelvis diameter [12 months]

   ultrasound measuerment of renal pelvis diameter by mm

Secondary Outcome Measures

1. operative time [one month]

   operative time by minutes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mohammad Daboos	Cairo	Select	Egypt	115678

Sponsors and Collaborators

• Al-Azhar University
• University Hospital Fattouma Bourguiba

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammad Daboos, Pediatric Surgery Department, Al-Azhar University., Al-Azhar University
• ClinicalTrials.gov Identifier: NCT05953571
• Other Study ID Numbers: 8-1-2022-000048
• First Posted: Jul 20, 2023
• Last Update Posted: Jul 20, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohammad Daboos, Pediatric Surgery Department, Al-Azhar University., Al-Azhar University: UPJO; Poorly function kidney; Laparoscopic assissted pyeloplasty; Open pyeloplasty; Pediatrics

Study Results

No Results Posted as of Jul 20, 2023