NCT05748964

Brief Summary

This study aimed to evaluate the clinical efficacy of laparoscopic pyeloplasty (LP) for ureteropelvic junction obstruction (UPJO) via retroperitoneal and transperitoneal approaches.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

February 18, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

February 18, 2023

Last Update Submit

February 28, 2023

Conditions

Urologic DiseasesSurgery

Keywords

UPJ obstructionpediatric urologypyeloplasty

Outcome Measures

Primary Outcomes (1)

  • Operative time

    Operative time

    From April 1, 2023 to April 1, 2024

Secondary Outcomes (3)

  • Convergence rate

    From April 1, 2023 to April 1, 2024

  • Post operative complications

    From April 1, 2023 to April 1, 2024

  • Hospital stay

    From April 1, 2023 to April 1, 2024

Study Arms (2)

Transperitoneal approach laparoscopic pyeloplasty. (TALP)

Transperitoneal approach laparoscopic pyeloplasty. (TALP)

Procedure: Laparoscopic pyeloplasty

Retroperitoneal Approach laparoscopic pyeloplasty. (RALP)

Retroperitoneal Approach laparoscopic pyeloplasty. (RALP)

Procedure: Laparoscopic pyeloplasty

Interventions

Laparoscopic pyeloplastyPROCEDURE

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)Transperitoneal approach laparoscopic pyeloplasty. (TALP)

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children diagnosed with unilateral ureteropelvic junction obstruction

You may qualify if:

  • Age above two years.
  • Unilateral UPJO.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr.

Study Record Dates

First Submitted

February 18, 2023

First Posted

March 1, 2023

Study Start

April 1, 2023

Primary Completion

April 1, 2024

Study Completion

June 1, 2025

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share