Ureteroscope Caliber and Surgeon Stress

Ureteroscope Diameter Influence 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.

Study Overview

• Status: Completed
• Conditions: Ureteral Stones; Ureteroscopic Lithotripsy
• Intervention / Treatment: Procedure: endoscopic ureteric lithotripsy

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.

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Aydın
    • Aydin, Aydın, Turkey (Türkiye), 09100
      • Aydın State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
4,5/6,5f URS; Group operated with 4.5/6.5f ureteroscope	Procedure: endoscopic ureteric lithotripsy; 2 different sizes of ureteroscopes, 4.5/6.5f and 8/9.8f, will be used in the study.
8/9,8f URS; Group operated with 8/9.8f ureteroscope	Procedure: endoscopic ureteric lithotripsy; 2 different sizes of ureteroscopes, 4.5/6.5f and 8/9.8f, will be used in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary objective of this study was to assess the surgeon's stress levels during the operation.	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. The lowest score that can be obtained from the scale is 6 and the highest score is 20. High score indicates high anxiety.	From enrollment to the end ofsurgery at 2 hours

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Study Chair: GÖKHAN ŞAHİN, Aydin Adnan Menderes University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2025
• Primary Completion (Actual): November 15, 2025
• Study Completion (Actual): November 15, 2025

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: ureteral stone; anxiety inventory; ureteroscoppic lithotripsy; ureteroscop
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Ureteral Diseases; Ureterolithiasis
• Other Study ID Numbers: decision:14 protocol no: 2025/

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is not planned to share individual participant data unless specifically requested by the journal in which the study will be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No