Different Surgical Approaches for Treatment of UPJ Obstruction in Children: Prospective Randomized Clinical Trial

February 28, 2023 updated by: Ahmed Kamel Ali Mohamed, Assiut University
This study aimed to evaluate the clinical efficacy of laparoscopic pyeloplasty (LP) for ureteropelvic junction obstruction (UPJO) via retroperitoneal and transperitoneal approaches.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Ureteropelvic junction obstruction (UPJO) is the most common congenital abnormality of the kidney and is responsible for flank pain, recurrent urinary infections, hydronephrosis and the loss of renal function. Until recently, open pyeloplasty (OP) was the standard surgical treatment modality for UPJO.However, with the development of laparoscopic devices and surgical technology, laparoscopic pyeloplasty (LP) has become a more beneficial choice for the patients with UPJO than open surgery because of the advantages of excellent visualization, minimal trauma, rapid postoperative recovery, good cosmetic result, and a nearly successful rate compared with open pyeloplasty. The first LP in children was performed in 1995. It has gained popularity for older children. LP can be performed though retroperitoneal and transperitoneal approaches. Which surgical method is better is still controversial.

Study Type

Observational

Enrollment (Anticipated)

20

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

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children diagnosed with unilateral ureteropelvic junction obstruction

Description

Inclusion Criteria:

  • Age above two years.
  • Unilateral UPJO.

Exclusion Criteria:

  • Age below two years.
  • Bilateral UPJO.
  • Recurrent UPJO.
  • Malrotated kidneys and renal fusion anomalies.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transperitoneal approach laparoscopic pyeloplasty. (TALP)
Transperitoneal approach laparoscopic pyeloplasty. (TALP)
Procedure: Laparoscopic pyeloplasty
Twenty patients presented with ureteropelvic junction obstruction [UPJO] will be divided into two equal groups. The first was subjected to trans-peritoneal pyeloplasty while the second was subjected to retroperitoneal pyeloplasty.
Retroperitoneal Approach laparoscopic pyeloplasty. (RALP)
Retroperitoneal Approach laparoscopic pyeloplasty. (RALP)
Procedure: Laparoscopic pyeloplasty
Twenty patients presented with ureteropelvic junction obstruction [UPJO] will be divided into two equal groups. The first was subjected to trans-peritoneal pyeloplasty while the second was subjected to retroperitoneal pyeloplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: From April 1, 2023 to April 1, 2024
Operative time
From April 1, 2023 to April 1, 2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Convergence rate
Time Frame: From April 1, 2023 to April 1, 2024
Convergence to open pyeloplasty
From April 1, 2023 to April 1, 2024
Post operative complications
Time Frame: From April 1, 2023 to April 1, 2024
Post operative complications
From April 1, 2023 to April 1, 2024
Hospital stay
Time Frame: From April 1, 2023 to April 1, 2024
Hospital stay
From April 1, 2023 to April 1, 2024

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

February 18, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKA1712

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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