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Completed

NCT Number: NCT06935500

Ureteroscope Caliber and Surgeon Stress

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aydın State Hospital

Aydin, Aydın, 09100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Presence of ureteral calculi
  • Use of Ho:YAG laser in ureteric lithotripsy
  • Patient's acceptance to participate in the study

Exclusion criteria

  • Presence of active urinary tract infection
  • Emergency operation of the patient
  • Presence of bilateral ureteral calculi
  • Patient refusal to participate in the study

Treatment and study plan

endoscopic ureteric lithotripsy

Procedure

2 different sizes of ureteroscopes, 4.5/6.5f and 8/9.8f, will be used in the study.

Primary outcomes

  1. Change in STAI-TX1 Score (Postoperative - Preoperative)

    Time frame: Immediately before and immediately after the procedure

    The State-Trait Anxiety Inventory (STAI), Form TX-1, is a validated instrument used to assess situational (state) anxiety. The STAI-TX1 consists of 20 items scored on a 4-point Likert scale, with total scores ranging from 20 to 80. Higher scores indicate greater levels of anxiety.

    In this study, the STAI-TX1 was administered immediately before and immediately after each procedure. A change score (ΔSTAI-TX1) was calculated by subtracting the preoperative score from the postoperative score (postoperative minus preoperative). Positive values (ΔSTAI-TX1 > 0) indicate an increase in anxiety, whereas values ≤ 0 indicate no increase or a decrease in anxiety.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

Ureteroscope Diameter Influence Surgeon Stress?

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2025
Registry last updated
Apr 13, 2026

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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