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Completed

NCT Number: NCT06122129

Flexible Ureteroscopy With and Without Ureteral Access Sheath in Treatment of Large Renal Stones

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Valley University

New Valley, New Valley Governorate, 72511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flexible ureteroscope with ureteral access sheath

Procedure

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.

Flexible ureteroscope without ureteral access sheath

Procedure

Ureteroscopy will be carried out without a ureteral access sheath

Primary outcomes

  1. Operative time

    Time frame: Intraperatively

    Time from sterilization till the end of surgery

Secondary outcomes

  1. Stone-free rate

    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

  2. Complications

    Time frame: 28 days after intervention

    Complications such as mucosal lacerations, bleeding, urosepsis, and stein Strasse.

  3. Duration of stay

    Time frame: 28 days after intervention

    Time from admission till hospital discharge

  4. Number of patients who need ancillary procedures

    Time frame: 28 days after intervention

    Need for Ancillary Procedures if there was residual.

Sponsors and collaborators

Lead sponsor

New Valley University

Other

Registry information

Official study title

Flexible Ureteroscopy With and Without Ureteral Access Sheath in Treatment of Large Renal Stones: a Randomized Controlled Trial.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2023
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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