Clinical trial NCT06122129: Flexible Ureteroscopy With and Without Ureteral Access Sheath in Treatment of Large Renal Stones
Official title: Flexible Ureteroscopy With and Without Ureteral Access Sheath in Treatment of Large Renal Stones: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flexible Ureteroscopy
Ureteral Access Sheath
Large Renal Stones
Lead sponsor: New Valley University
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the flexible ureteroscope (FURS) technique with and without ureteral access sheath (UAS).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old.
* Both sexes.
* Patients with upper ureter and renal stones scheduled for flexible ureteroscope.

Exclusion Criteria:

* Patients with associated distal ureteral stone, kidney transplant or any kind of urinary diversion.
* Larger stones (11 cm) where the routine use of an access sheath will be felt appropriate to aid multiple passes of the scope.
* Known ureteric strictures.
* Concomitant ureteric stones.
* Patients with narrow ureter where ureteral access sheath was anticipated to be difficult.

Primary outcomes:
measure: Operative time
timeFrame: Intraperatively
Secondary outcomes:
measure: Stone-free rate
timeFrame: 28 days after intervention
measure: Complications
timeFrame: 28 days after intervention
measure: Duration of stay
timeFrame: 28 days after intervention
measure: Number of patients who need ancillary procedures
timeFrame: 28 days after intervention
Other outcomes:
Locations:
city: New Valley
country: Egypt
facility: New Valley University
Study officials:
References: