New Valley University
New Valley, New Valley Governorate, 72511, Egypt
NCT Number: NCT06122129
The aim of this study is to evaluate the flexible ureteroscope (FURS) technique with and without ureteral access sheath (UAS).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
New Valley, New Valley Governorate, 72511, Egypt
Treating a large renal stone, more than 2 cm, is changing during the last decades. Technological innovations have led to a significant improvement in flexible ureteroscopes over recent years.
Many authors have used flexible ureteroscope (FURS) with laser fragmentation as proved treating modality with high efficacy. Although percutaneous extraction of large renal stones is still the first option, it has higher and more severer complications than flexible ureteroscopy.
FURS has developed into a standard diagnostic and treatment modality for upper urinary stone disease, transitional cell carcinoma and ureteral strictures. Indeed, more recently FURS is becoming a minimally invasive competitor to percutaneous nephrolithotomy for larger kidney stones as well as an accepted modality for localized treatment of small upper urinary tract transitional cell carcinoma.
The use of ureteral access sheath (UAS) is widely recognized as a technique utilized to keep the intrarenal pressure low when performing FURS for larger and more complex stones, although some authors advocate its use for most renal stones. UASs are now produced with varying characteristics including various lengths, diameters, materials, dilator tip designs, radiopaque markers, and stiffness. However, it also rises surgical costs and may injure the ureteral wall.
Most common reasons cited by urologists for using a UAS are to facilitate repeated entrance into the ureter and collecting system (as a time-saver), lower intrarenal pressure and protection of ureteroscope and ureter when extracting stone fragments. UAS has encouraged urologists in the fragmentation of large stones; it facilitates multiple entries and stone extraction during FURS.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The flexible ureteroscope either directly or via an access sheath, depending on the size of the ureter, a 9.5/11.5 Fr or a 12 Fr access sheath will be used.
Ureteroscopy will be carried out without a ureteral access sheath
Time frame: Intraperatively
Time from sterilization till the end of surgery
Time frame: 28 days after intervention
Stone-free status was defined as no residual stones or residual stones with a maximum diameter ≤ 4 mm with no clinical symptoms at 1 month after the procedure
Time frame: 28 days after intervention
Complications such as mucosal lacerations, bleeding, urosepsis, and stein Strasse.
Time frame: 28 days after intervention
Time from admission till hospital discharge
Time frame: 28 days after intervention
Need for Ancillary Procedures if there was residual.
New Valley University
Other
Flexible Ureteroscopy With and Without Ureteral Access Sheath in Treatment of Large Renal Stones: a Randomized Controlled Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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