Evaluation of stent biomaterial encrustation

JRCT ID: jRCT1042200004

Registered date:21/04/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: urolithiasis
• Date of first enrollment: 15/06/2020
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Tria group: 6Fr TriaTM ureteral stent placement at the end of the surgery
Percu group:6Fr PercuflexTM ureteral stent placement at the end of the surgery
InLay group:6Fr InLay Optima ureteral stent placement at the end of the surgery

Outcome(s)

Primary Outcome

1.stent encrustation
2.Bacteria attachment to the ureteral stent

• Secondary Outcome: ureteral stent symptom, surgeon questionnaire as regard to stent insertion and removal, stent location, perioperative complication

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1) Patients whose age are between 16 and 80 years old, diagnosed with renal and/or upper ureteral stone at Nagoya City University Hospital, and planned for endoscopic surgery
2) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0 or 1
3) Patients who were obtained written informed consent
- obtained written informed consent from themselves if they are 20 years old and older
- obtained written informed consent from themselves and representatives are between 16 and 19 years old

Exclude criteria

A)women with pregnant or its possibility
B)difficult status for general/lumber anesthesia judged by anesthesiologist
C)nephrostomy placement after surgery
D)patients with urinary diversion

Related Information

• Primary Sponsor: Hamamoto Shuzo