NCT06822270

Brief Summary

The study compared open pyeloplasty (OP) and laparoscopic pyeloplasty (LP) for treating Pelvi-ureteric Junction Obstruction (PUJO) in 40 patients.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

October 11, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

Same day

First QC Date

December 28, 2024

Last Update Submit

February 6, 2025

Conditions

Pelvi-ureteric Junction Obstruction

Outcome Measures

Primary Outcomes (1)

  • Operative Success Rate

    evaluating the effectiveness of each surgical method in resolving PUJO

    3 days

Study Arms (2)

Open Pyeloplasty Group

ACTIVE COMPARATOR

This group underwent traditional open surgical methods for treating Pelvi-ureteric Junction Obstruction.

Procedure: open surgery

Laparoscopic Pyeloplasty Group (LP)

EXPERIMENTAL

This group was treated using minimally invasive laparoscopic techniques.

Procedure: Laparoscopic Pyeloplasty

Interventions

open surgeryPROCEDURE

open surgical methods for treating Pelvi-ureteric Junction Obstruction

Open Pyeloplasty Group
Laparoscopic PyeloplastyPROCEDURE

minimally invasive laparoscopic techniques.

Laparoscopic Pyeloplasty Group (LP)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 7 months and 60 years. Diagnosed with Pelvi-ureteric Junction Obstruction (PUJO). Glomerular Filtration Rate (GFR) greater than 10 ml/min. Open to both genders.

You may not qualify if:

  • Active infection. GFR less than 10 ml/min. Presence of a single kidney. Patients with kidney or multiple congenital anomalies. Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Al-Azhar University

Asyut, Egypt

Location

Related Publications (1)

  • Bar-Sever Z, Shammas A, Gheisari F, Vali R. Pediatric Nephro-Urology: Overview and Updates in Diuretic Renal Scans and Renal Cortical Scintigraphy. Semin Nucl Med. 2022 Jul;52(4):419-431. doi: 10.1053/j.semnuclmed.2021.12.002. Epub 2022 Jan 11.

    PMID: 35031115BACKGROUND

MeSH Terms

Conditions

Multicystic renal dysplasia, bilateral

Interventions

Conversion to Open Surgery

Intervention Hierarchy (Ancestors)

EndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 28, 2024

First Posted

February 12, 2025

Study Start

October 11, 2024

Primary Completion

October 11, 2024

Study Completion

December 4, 2025

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations

EG(1)