Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pyeloplasty
Complications of Surgical Procedures or Medical Care
Hospital Stay
Keywords: Pyleoplasty
Hospital Stay
Complications
DJS
PUJO
Lead sponsor: Hayat Abad Medical Complex, Peshawar.
Sponsor class: OTHER_GOV
First posted: 2025-02-26
Enrollment: 140
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Complication Rate
timeFrame: up to 4 weeks on post follow up on clinical examination and relevant investigations
Secondary outcomes:
measure: Cost Effectiveness
timeFrame: one month on post follow up on clinical examination and relevant investigation
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Institute of Kidney Disease.
state: KPK
Study officials:
affiliation: Institute Of kidney Diseases
name: Abdul Haseeb, MBBS, MRCS
role: PRINCIPAL_INVESTIGATOR
References: