NCT06847841

Brief Summary

Open pyeloplasty is a common surgical intervention for pediatric patients with ureteropelvic junction obstruction. Post-operative management strategies, including the use of a double J stent and a percutaneous feeding tube, vary widely. While both options have demonstrated effectiveness in drainage, their relative clinical outcomes, costs, and overall value in pediatric urology remain unclear. This randomized controlled trial (RCT) aims to compare the clinical efficacy and cost-effectiveness of these two post-operative interventions in pediatric patients undergoing open pyeloplasty.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 21, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2025

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 21, 2025

Last Update Submit

February 25, 2025

Conditions

PyeloplastyComplications of Surgical Procedures or Medical CareHospital Stay

Keywords

PyleoplastyHospital StayComplicationsDJSPUJO

Outcome Measures

Primary Outcomes (1)

  • Complication Rate

    Rate of Complication including pain, bleeding, re operation

    up to 4 weeks on post follow up on clinical examination and relevant investigations

Secondary Outcomes (1)

  • Cost Effectiveness

    one month on post follow up on clinical examination and relevant investigation

Study Arms (1)

PUJO

ACTIVE COMPARATOR

Patients having PUJ Obstruction and booked for open pyeloplasty

Procedure: Double J Stent PlacementProcedure: Percutaneous Feeding Tube Placement

Interventions

Double J Stent PlacementPROCEDURE

Patient in whom a DJS will be placed for post op drainage

PUJO
Percutaneous Feeding Tube PlacementPROCEDURE

Patient in whom a PrcFT will be placed for post op drainage

PUJO

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients with primary PUJO and outflow obstruction on renal Scan who are candidates for elective open pyeloplasty

You may not qualify if:

  • Patients who are previous operated for PUJO , and having recurrence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Kidney Disease.

Peshawar, KPK, 25124, Pakistan

Location

Study Officials

  • Abdul Haseeb, MBBS, MRCS

    Institute Of kidney Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post graduate resident

Study Record Dates

First Submitted

February 21, 2025

First Posted

February 26, 2025

Study Start

January 10, 2025

Primary Completion

July 10, 2025

Study Completion

July 10, 2025

Last Updated

February 26, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

As part of our commitment to research transparency and data-sharing practices, we plan to share individual participant data (IPD) obtained from this clinical trial. The purpose of sharing IPD is to enable further research, facilitate meta-analyses, and contribute to scientific advancements that can improve patient care and clinical outcomes. Scope of Data to be Shared The de-identified individual participant data that will be shared includes: Demographic details such as age, sex, and relevant baseline characteristics Clinical and laboratory data collected during the study Outcome measures related to the study objectives Adverse event reports and safety data All shared data will be de-identified to ensure participant confidentiality and privacy in accordance with applicable ethical guidelines and regulatory requirements.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
The data will be made publicly available six months after the primary study results are published in a peer-reviewed journal. The dataset will remain accessible for a period of five years from the initial release, after which continued access will be evaluated based on scientific interest and data usage
Access Criteria
The IPD will be stored in a secure, electronic form with the principal investigator. Researchers interested in accessing the data will be required to submit a request to the principal author via this email: ahaseeb.dr@gmail.com Conditions for Data Access Access to the shared data will be granted to qualified researchers affiliated with recognized academic or clinical institutions. Interested researchers must submit a methodologically sound research proposal outlining the objectives and intended use of the data. Approval will be based on scientific merit and alignment with ethical standards. Before access is granted, researchers will be required to: Sign a Data Use Agreement (DUA) to ensure appropriate use of the dataset Agree to maintain confidentiality and not attempt to re-identify participants Provide a commitment to acknowledge the original study and funding sources in any resulting publications

Locations

PA(1)