Complications of Surgical Procedures or Medical Care, Hospital Stay, Pyeloplasty
Conditions
Keywords
Pyleoplasty, Hospital Stay, Complications, DJS, PUJO
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
Interventions
PROCEDUREDouble J Stent Placement
Patient in whom a DJS will be placed for post op drainage
PROCEDUREPercutaneous Feeding Tube Placement
Patient in whom a PrcFT will be placed for post op drainage
Sponsors
Hayat Abad Medical Complex, Peshawar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rate | up to 4 weeks on post follow up on clinical examination and relevant investigations | Rate of Complication including pain, bleeding, re operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost Effectiveness | one month on post follow up on clinical examination and relevant investigation | Whether PrcFT is cost effective than DJS or not |
Countries
Pakistan
Outcome results
None listed