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Direct In-Scope Suction Versus Standard Flexible Ureterorenoscopy

ConditionRenal Stone Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHitit University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older.

A single stone located in the kidney or proximal ureter.

Scheduled to undergo retrograde intrarenal surgery (RIRS) by the study's surgical team.

Disqualifiers

Multiple renal or proximal ureteral stones.

Age younger than 18 years.

Pregnancy.

Preoperative urinary tract infection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard flexible ureterorenoscope

    Device

    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

    Device

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Standard Flexible UreterorenoscopyActive comparator 1 intervention
Group B: Direct In-Scope Suction Flexible UreterorenoscopyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Postoperative Fever

Number and percentage of participants with a recorded body temperature \>38°C within 48 hours after surgery.

Time frame
Within 48 hours after surgery

Secondary outcomes

1

Incidence of Postoperative Systemic Inflammatory Response Syndrome

Number and percentage of participants meeting at least two of the following criteria: temperature \>38°C or \<36°C, heart rate \>90 beats/min, respiratory rate \>20 breaths/min, or white blood cell count \>12,000/mm³ or \<4,000/mm³.

Time frame
Within 48 hours after surgery
2

Incidence of Postoperative Sepsis

Number and percentage of participants with suspected or confirmed infection who also meet the protocol-defined systemic inflammatory response syndrome criteria.

Time frame
Within 48 hours after surgery
3

Stone-Free Rate

Number and percentage of participants with no residual stone or residual fragments ≤4 mm on non-contrast computed tomography.

Time frame
4 weeks after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hitit University

Lead sponsor

Source ClinicalTrials.gov
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