Ureteroscope Caliber and Surgeon Stress

NCT06935500 | Completed Results

• 1 other identifier: decision:14 protocol no: 2025/
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ureteral Stones; Ureteroscopic Lithotripsy

Keywords

ureteral stone; anxiety inventory; ureteroscoppic lithotripsy; ureteroscop

Outcome Measures

Primary Outcomes (1)

• Change in STAI-TX1 Score (Postoperative - Preoperative)

  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.

  Immediately before and immediately after the procedure

Study Arms (2)

4,5/6,5f URS

Group operated with 4.5/6.5f ureteroscope

Procedure: endoscopic ureteric lithotripsy

8/9,8f URS

Group operated with 8/9.8f ureteroscope

Procedure: endoscopic ureteric lithotripsy

Interventions

endoscopic ureteric lithotripsy PROCEDURE

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

4,5/6,5f URS; 8/9,8f URS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients between 18-75 years of age who applied to the urology outpatient clinic and were planned for elective endoscopic ureteral stone operation

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın State Hospital

Aydin, Aydın, 09100, Turkey (Türkiye)

Location

Related Publications (4)

• Jones KI, Amawi F, Bhalla A, Peacock O, Williams JP, Lund JN. Assessing surgeon stress when operating using heart rate variability and the State Trait Anxiety Inventory: will surgery be the death of us? Colorectal Dis. 2015 Apr;17(4):335-41. doi: 10.1111/codi.12844.

  PMID: 25406932 BACKGROUND

• Omar M, Dorrah M, Khalifa A, El Sherif E, Sayedahmed K, Ghazwani Y, Noureldin YA. Randomized comparison of 4.5/6 Fr versus 6/7.5 Fr ureteroscopes for laser lithotripsy of lower/middle ureteral calculi: towards optimization of efficacy and safety of semirigid ureteroscopy. World J Urol. 2022 Dec;40(12):3075-3081. doi: 10.1007/s00345-022-04173-2. Epub 2022 Oct 8.

  PMID: 36208314 BACKGROUND

• Uzun H, Akca N. Is the 4.5-F ureteroscope (Ultra-Thin) an alternative in the management of ureteric and renal pelvic stones? Arab J Urol. 2018 Jun 21;16(4):429-434. doi: 10.1016/j.aju.2018.04.006. eCollection 2018 Dec.

  PMID: 30534443 BACKGROUND

• Atis G, Arikan O, Gurbuz C, Yildirim A, Erol B, Pelit S, Ulus I, Caskurlu T. Comparison of different ureteroscope sizes in treating ureteral calculi in adult patients. Urology. 2013 Dec;82(6):1231-5. doi: 10.1016/j.urology.2013.07.021. Epub 2013 Sep 12.

  PMID: 24035032 BACKGROUND

MeSH Terms

Conditions

Ureterolithiasis

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Limitations and Caveats

No interpretative statements are provided in this section. All results are presented in the corresponding outcome measure data tables.

Results Point of Contact

• Title: Gökhan Şahin, MD
• Organization: Aydın State Hospital , Aydın, Turkey

gokhansahinn7510@gmail.com

+905543924200

Study Officials

• GÖKHAN ŞAHİN

  Aydin Adnan Menderes University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 20, 2025
• Study Start: July 10, 2025
• Primary Completion: November 15, 2025
• Study Completion: November 15, 2025
• Last Updated: April 13, 2026
• Results First Posted: April 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)