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

NCT ID: NCT06847841

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2025-07-10

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

Conditions

Pyeloplasty; Complications of Surgical Procedures or Medical Care; Hospital Stay

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

PUJO

Patients having PUJ Obstruction and booked for open pyeloplasty

Group Type: ACTIVE_COMPARATOR

Double J Stent Placement

Intervention Type: PROCEDURE

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

Percutaneous Feeding Tube Placement

Intervention Type: PROCEDURE

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

Interventions

Double J Stent Placement

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

Intervention Type: PROCEDURE

Percutaneous Feeding Tube Placement

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hayat Abad Medical Complex, Peshawar.

OTHER_GOV

Sponsor Role: lead

Responsible Party

Abdul Haseeb

Post graduate resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdul Haseeb, MBBS, MRCS

Role: PRINCIPAL_INVESTIGATOR

Institute Of kidney Diseases

Locations

Institute of Kidney Disease.

Peshawar, KPK, Pakistan

Countries

Pakistan

Other Identifiers

Institute of Kidney Diseases

Identifier Type: OTHER

Identifier Source: secondary_id

2376/HMC-QAD-F

Identifier Type: -

Identifier Source: org_study_id