Stone, Kidney, Stone Ureter
Conditions
Keywords
Retrograde Intra Renal Surgery (RIRS), Flexible uretroscopy, Laser disintegration, Alpha blocker selective, Silodosin
Brief summary
This study aims to provide robust evidence on whether a specific, potent pre-operative medication (silodosin) can make the critical step of ureteral access (UAS placement after dilation) easier and safer during f-URS for kidney stones in non-stented patients, potentially reducing complications and the need for pre-stenting.
Detailed description
This study specifically evaluates the effect of administering pre-operative silodosin (8mg daily for one week) on facilitating ureteral dilation prior to ureteral access sheath (UAS) placement during flexible ureteroscopy (f-URS), aiming to leverage the drug's potent ureteral smooth muscle relaxation to ease mechanical dilation with Teflon dilators (6-14Fr) and subsequent UAS insertion. Its primary endpoint directly measures the ease of UAS placement (categorized as smooth, resistant, or failed) after sequential dilation. To objectively assess safety, post-operative diagnostic ureteroscopy by a second surgeon grades ureteral wall injuries using a specific 5-grade scale. Employing a rigorous randomized, placebo-controlled trial (RCT) design with strict criteria (non-stented patients, stone burden 1-2 cm, no prior interventions), the study also evaluates secondary outcomes including ureteral injury severity, stone-free rates (SFR), post-operative pain (VAS), complications, hospital stay length, and medication side effects.
Interventions
PROCEDUREPreoperative sioldosin to facilitate ureteric access sheath insertion in RIRS
group A (study group) that included 21 patients who received silodosin 'one capsule 8 mg per day for 1 week preoperatively
PROCEDUREureteric access sheath insertion in RIRS without silodosin (Placebo)
group B (study group) that included 21 patients who received Placebo'one capsule per day for 1 week preoperatively
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* adult male or female * single renal or ureteric stone * 1 to 2 cm in size.
Exclusion criteria
* pregnant women * Untreated urinary tract infections * Uncorrected bleeding disorders or coagulopathies * Bilateral ureteric stones or multiple ipsilateral ureteric stones * ureteral stricture, * Patients who had previous ureteric stenting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess success of ureteric access sheath placement. | during the operation in the OR | assess success of ureteric access sheath placement as follows: 1. spontaneous passage of UAS without dilatation or 2. passage of UAS after dilatation or 3. failure of the UAS insertion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | from time of induction of anaesthesia in surgery till the end of procedure. | — |
| Cost of the procedure | from admission and through study completion | Overall cost of each procedure included cost of standard procedure of flexible URS added to cost of medication prior to operations. If any case needed ureteral dilatation, the cost of dilators was added. Also, in case of complications occurred, additional cost of management of these complications was added. Finally, in cases of failed UAS insertion, the cost of auxiliary procedure was added. Cost was calculated initially in Egyptian pounds and was converted to U.S dollars for standardization. |
| complications | Perioperative and up to 24 weeks | Assess postoperativePain, fever and Residual stones |
Countries
Egypt
Outcome results
None listed