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OpenTrials
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NCT Number: NCT06847841

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Kidney Disease.

Peshawar, KPK, 25124, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Double J Stent Placement

Procedure

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

Percutaneous Feeding Tube Placement

Procedure

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

Primary outcomes

  1. Complication Rate

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

    Rate of Complication including pain, bleeding, re operation

Secondary outcomes

  1. Cost Effectiveness

    Time frame: one month on post follow up on clinical examination and relevant investigation

    Whether PrcFT is cost effective than DJS or not

Sponsors and collaborators

Lead sponsor

Hayat Abad Medical Complex, Peshawar

Other Gov

Registry information

Acronym: DJS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2025
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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