Different Surgical Modalities in the Management of Pelvi-ureteric Junction Obstruction

February 6, 2025 updated by: Mohamed Gamil Ahmed Saleh, Assiut University

Evaluation of Different Surgical Modalities in the Management of Pelvi-ureteric Junction Obstruction: a Randomized Controlled Trial

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assuit, Egypt
        • Faculty of Medicine Al-Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open Pyeloplasty Group
This group underwent traditional open surgical methods for treating Pelvi-ureteric Junction Obstruction.
Procedure: open surgery
open surgical methods for treating Pelvi-ureteric Junction Obstruction
Experimental: Laparoscopic Pyeloplasty Group (LP)
This group was treated using minimally invasive laparoscopic techniques.
Procedure: Laparoscopic Pyeloplasty
minimally invasive laparoscopic techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative Success Rate
Time Frame: 3 days
evaluating the effectiveness of each surgical method in resolving PUJO
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2024

Primary Completion (Actual)

October 11, 2024

Study Completion (Estimated)

December 4, 2025

Study Registration Dates

First Submitted

December 28, 2024

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD/AZ.AST/AIP029/21/186/3/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual Participant Data (IPD) might not be shared due to privacy and confidentiality concerns. The ethical considerations mentioned in the study include informed consent obtained from patients regarding the surgery and data privacy. Sharing IPD could potentially compromise patient anonymity and expose sensitive personal health information, which must be protected under ethical research practices and relevant data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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