Cost-Effectiveness and Clinical Outcomes of Double J Stent Versus Percutaneous Feeding Tube Placement Following Open Pyeloplasty in Pediatric Patients: A Prospective Randomized Single-center Study (DJS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pyeloplasty; Hospital Stay; Complications of Surgical Procedures or Medical Care
• Intervention / Treatment: Procedure: Double J Stent Placement; Procedure: Percutaneous Feeding Tube Placement

Detailed Description

This is going to be a prospective randomized study of pediatric patients undergoing open pyeloplasty in Department of Pediatric Urology, Institute of Kidney Diseases, Peshawar. After obtaining approval from the ethical committee board of the hospital. The aim and benefits of the study will be well explained to the parents of all the patients, and they will be briefed as well that no risk is involved while participating in this study. Then informed consent will be obtained and the patients will be randomly assigned to receive either a double J stent or a percutaneous feeding tube for post-operative drainage. Randomization will be performed using block randomization to ensure balance between groups. A mix of both consecutive and purposive sampling technique to recruit patient until the desire sample size is reached. The primary outcomes included pain relief, the rate of complications like post op infection, obstruction, and length of hospital stay. Secondary outcomes included incidence of re-operations, and cost analysis of the two interventions. A cost-effectiveness analysis will be conducted from the healthcare provider's perspective, considering direct medical costs (surgical, hospitalization, and follow-up care) and the quality-adjusted life years (QALYs) for each group. Data will be analyses using SPSS and results will be reported

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • KPK
    • Peshawar, KPK, Pakistan, 25124
      • Institute of Kidney Disease.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PUJO; Patients having PUJ Obstruction and booked for open pyeloplasty	Procedure: Double J Stent Placement; Patient in whom a DJS will be placed for post op drainage; Procedure: Percutaneous Feeding Tube Placement; Patient in whom a PrcFT will be placed for post op drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost Effectiveness	Whether PrcFT is cost effective than DJS or not	one month on post follow up on clinical examination and relevant investigation

Collaborators and Investigators

• Sponsor: Hayat Abad Medical Complex, Peshawar.
• Investigators: Principal Investigator: Abdul Haseeb, MBBS, MRCS, Institute Of kidney Diseases

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): July 10, 2025
• Study Completion (Estimated): July 10, 2025

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 25, 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 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Complications; Hospital Stay; Pyleoplasty; DJS; PUJO
• Other Study ID Numbers: 2376/HMC-QAD-F; Institute of Kidney Diseases (Other Identifier: Institute of Kidney Diseases)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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

IPD Sharing 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

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No