Ureteral Access Sheath or Percutaneous Nephrostomy During Flexible Ureteroscopy: Which is Better?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Benha University
- Enrollment
- 100
- Primary Endpoint
- intra-operative complications
Study Overview
Brief Summary
we aim to compare the safety and efficacy of flexible ureteroscopy with ureteral access sheath (group A) in comparison with flexible ureteroscopy without UAS but with PCN insertion (group B) either intra or post operaively by recording all data and the benefits , also comparing the drawbacks on each group
Detailed Description
A prospective randomized controlled study will be conducted at benha university hospitals on adult patients with renal and, or upper ureteric stones which will meet the inclusion criteria will participate in the study comparing usage of ureteral access sheath and percutaneous nephrostomy during flexible ureteroscopy. After filling out the informed consent form, patients will be randomly assigned to one of the two groups.
Group A: 50 patients will be operated using UAS during flexible ureteroscopy. Group B: 50 patients will be operated using PCN during flexible ureteroscopy.
Inclusion/Exclusion criteria:
Inclusion criteria consists of adult patients with upper ureteric stones and mild hydronephrosis or renal pelvic stones less than 20 mm with mild hydronephrosis.
Exclusion criteria include patients with active urinary tract infection and patients with uncontrolled coagulable status.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with upper ureteric stones and mild hydronephrosis or renal pelvic stones less than 20 mm with mild hydronephrosis
Exclusion Criteria
- •patients with active urinary tract infection and patients with uncontrolled coagulable status
Outcomes
Primary Outcomes
intra-operative complications
Time Frame: 3 mothes
Operative time, intra-operative complications (bleeding, perforation, incompletion of procedure) and hospitalization periods
Secondary Outcomes
No secondary outcomes reported
Investigators
mohamed abdelrahman alhefnawy
assistant professor
Benha University