NCT06935500

Ureteroscope Caliber and Surgeon Stress

Ureteroscope Diameter Influence Surgeon Stress?

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 130 (actual)
• Sponsor: Aydin Adnan Menderes University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the efficacy, success rates, and stone-free rates of endoscopic ureteral stone treatment performed using two different sizes of ureteroscopes. Additionally, the psychological stress experienced by the surgeon will be evaluated immediately before and immediately after the procedure using the six-item short-form of the State Scale of the Spielberger State-Trait Anxiety Inventory (STAI). The findings will provide insight into the impact of ureteroscope size on procedural outcomes and surgeon stress levels, contributing to the optimization of ureteroscopic stone treatment.

Detailed description

Patients admitted to our clinic with ureteral calculi and scheduled for ureteroscopic lithotripsy were informed about the procedure, potential complications, and routine clinical protocol. Patients who consented to surgery subsequently received detailed information about the study, and written informed consent was obtained from those who agreed to participate. Participants were randomly assigned in a 1:1 ratio to undergo ureteroscopy using either a 4.5-6.5 Fr semirigid ureteroscope or an 8-9.8 Fr semirigid ureteroscope. Randomization was performed using a computer-generated simple randomization sequence. Group allocation was concealed using sequentially numbered opaque sealed envelopes, which were opened immediately before the procedure. All ureteroscopic procedures were performed according to standard institutional protocols. Intraoperative parameters, including operative duration, complications, double-J stent placement, failure to access the stone, and basket use, were recorded prospectively by the research team. To evaluate the impact of ureteroscope caliber on surgical stress, the operating surgeon's stress level was assessed immediately before and after each procedure using the State-Trait Anxiety Inventory Form TX-1 (STAI-TX1). Postoperatively, all patients underwent supine direct abdominal radiography on postoperative day one in accordance with routine clinical practice. Stone-free status was determined based on radiographic evaluation and recorded by the investigator. No modifications were made to standard perioperative care during the study period.

Conditions

• Ureteral Stones
• Ureteroscopic Lithotripsy

Interventions

Type	Name	Description
PROCEDURE	endoscopic ureteric lithotripsy	2 different sizes of ureteroscopes, 4.5/6.5f and 8/9.8f, will be used in the study.

Timeline

• Start date: 2025-07-10
• Primary completion: 2025-11-15
• Completion: 2025-11-15
• First posted: 2025-04-20
• Last updated: 2026-04-13
• Results posted: 2026-04-13

Locations

1 site across 1 country: Turkey (Türkiye)