Direct In-Scope Suction Versus Standard Flexible Ureterorenoscopy

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard flexible ureterorenoscope: A 7.5 Fr reusable Storz Flex-X2 flexible ureterorenoscope without direct in-scope suction will be used for retrograde intrarenal surgery. Stone fragmentation will be performed with a Holmium:YAG laser through a 9.5/11.5 Fr ureteral access sheath.

Flexible ureterorenoscope with direct in-scope suction: A 7.5 Fr single-use Claritron flexible ureterorenoscope equipped with direct in-scope suction will be used for retrograde intrarenal surgery. Suction through the scope will be available during irrigation and Holmium:YAG laser lithotripsy. A 9.5/11.5 Fr ureteral access sheath will be used.

Study summary

This prospective study aims to compare the clinical, perioperative, and postoperative outcomes of flexible ureterorenoscopy using a direct in-scope suction system (DISS) with standard flexible ureterorenoscopy in patients undergoing retrograde intrarenal surgery for renal or proximal ureteral stones. A total of 70 patients will be enrolled, with 35 patients in each group. The study will assess postoperative infectious complications, including fever, systemic inflammatory response syndrome (SIRS), and sepsis, as well as operative parameters, length of hospital stay, reoperation, and stone-free status. Stone-free status will be assessed by non-contrast computed tomography four weeks after surgery.

Eligibility

Primary outcome measure(s)

• Incidence of Postoperative Fever — Within 48 hours after surgery
  Number and percentage of participants with a recorded body temperature \>38°C within 48 hours after surgery.

Trial sites (1)

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