Stones, Kidney, Ureteric Injury
Conditions
Keywords
Aminophylline, Ureteric access sheath, ureteric injury, Flexible Uretroscopy
Brief summary
in this study we are going to evaluate the efficacy of intra-ureteric aminophylline instillation in facilitating ureteric access sheath placement prior to flexible ureteroscopy in reducing ureteric injury rates.
Detailed description
Urolithiasis (kidney and ureteral stones) is a common urologic condition with increasing prevalence. Flexible ureteroscopy (FURS) is a minimally invasive technique widely used for upper ureteric and renal stones. Aminophylline, a methylxanthine derivative, has been shown to relax smooth muscles and was previously used intravesically to facilitate rigid ureteroscopy with reduced complications. This study aims to assess whether intra-ureteric aminophylline instillation improves the ease of ureteral access sheath (UAS) placement during FURS and reduces ureteric injuries. patients will be divided into 3 groups: 1. Group A (Aminophylline Group): Intra-ureteric instillation of aminophylline 2. Group B (Ureteral Dilator Group): Traditional ureteral dilators 3. Group C (Combination Group): Aminophylline instillation + Ureteral dilators follow up of the patients will be through the success rate or failure of ureteric access sheath placement, operative time, bleeding, intra/postoperative complications and stone clearance (3-week follow-up with CT scan)
Interventions
DRUGUsage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy
Intraureteric aminophylline installation prior to ureteric dilatation
DEVICESequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy
traditional ureteral dilators will be used. We will start by ureteral dilator 6 fr and gradually increase the size up to 12 Fr
OTHERAminophylline instillation and Ureteral dilators together
Aminophylline will be instilled as in group (A) then followed by traditional ureteral dilatation as in group (B) prior to placing the ureteric access sheath
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Upper ureteric stones or renal stones \< 2 cm
Exclusion criteria
1. Ureteric strictures. 2. anatomic renal disorders 3. functional renal disorders 4. Urinary tract infection. 5. Coagulopathy and uncorrected bleeding disorders. 6. Prior DJ stenting 7. any contraindication for aminophylline use: (hypersensitivity to theophylline, ethylenediamine, or any component of the drug formulation, pregnancy or lactation, active peptic ulcer, presence of cardiologic diseases, presence of neurologic diseases, presence of renal impairment and presence of hepatic dysfunction)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The successful placement of ureteric access sheath | intraoperative application of the access sheath | we will assess the successful placement of ureteric access sheath in patients (that the access sheath is passed on the guide wire till the pelviureteric junction portion of the ureter after the usage of intraureteric aminophylline or teflon dilators or the usage of both. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| successful stone clearance | 3 weeks postoperative follow up with urinary tract multislice CT | the stone free rate following intervention |
Countries
Egypt
Contacts
Primary ContactAli Khaled Mohammed Ali Dr. Ali Khaled, MSc.
Backup ContactYounan Samir, PhD
Outcome results
None listed