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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Aminophylline Group: Intra-ureteric instillation of aminophylline | Experimental | a ureteric catheter 6 Fr will be used for instillation of normal saline supplemented with aminophylline 250 mg/10 mL at three points (Pelvi-ureteric junction, upper sacroiliac joint level and proximal to uretero-vesical junction by 5 cm) then wait for 5 minutes |
|
| Group B: Ureteral Dilator Group: Traditional ureteral dilators | Active Comparator | traditional ureteral dilators will be used. We will start by ureteral dilator 6 fr and gradually increase the size up to 12 Fr |
|
| Group C: Combination Group: Aminophylline instillation and Ureteral dilators | Other | Aminophylline will be instilled as in group (A) then followed by traditional ureteral dilatation as in group (B) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy | Drug | Intraureteric aminophylline installation prior to ureteric dilatation |
|
| Measure | Description | Time Frame |
|---|---|---|
| The successful placement of ureteric 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. | intraoperative application of the access sheath |
| Measure | Description | Time Frame |
|---|---|---|
| successful stone clearance | the stone free rate following intervention | 3 weeks postoperative follow up with urinary tract multislice CT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ali Khaled Mohammed Ali Dr. Ali Khaled, MSc. | Contact | +201099978174 | ali.khaled94@gmail.com | |
| Younan Samir, PhD | Contact | +201201255511 | dr_yona@live.com |
| Name | Affiliation | Role |
|---|---|---|
| Younan Samir, PhD | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Recruiting | Cairo | Abassia | 11517 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35618855 | Background | Shabayek M, Osman T, Wahb M, Elmoazen M, Osman D, Saafan A. Intravesical aminophylline instillation as an alternative for balloon dilatation prior to semi-rigid ureteroscopic management of distal ureteral stones. World J Urol. 2022 Jul;40(7):1805-1811. doi: 10.1007/s00345-022-04039-7. Epub 2022 May 26. |
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|
| Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy | Device | traditional ureteral dilators will be used. We will start by ureteral dilator 6 fr and gradually increase the size up to 12 Fr |
|
|
| Aminophylline instillation and Ureteral dilators together | Other | 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 |
|
|
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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