Clinical trial NCT06935500: Comparison of 4.5/6.5F and 7.5/9.5F Ureteroscopes in Endoscopic Ureteral Stone Treatment
Official title: Comparison of 4.5/6.5F and 7.5/9.5F Ureteroscopes in Endoscopic Ureteral Stone Treatment: What About Suregeon's Anxiety ?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ureteral Stones
Ureteroscopic Lithotripsy
Keywords: ureteral stone
anxiety inventory
ureteroscoppic lithotripsy
ureteroscop
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed description: Patients admitted to our clinic with ureteral calculi and scheduled for ureteroscopic lithotripsy will be informed about the procedure, potential complications, and routine protocol by the investigator. Patients who consent to the operation will subsequently receive detailed information about the study. Those agreeing to participate will provide written informed consent.

During the ureteroscopy procedure, standard clinical protocols will be followed. The choice of ureteroscope (4.5-6 Fr or 7.5-9.5 Fr) will be made by the operating urologist based on the patient's ureteral orifice and ureteral width. The study will not influence the selection of the ureteroscope. Intraoperative parameters, including procedure duration, complications, Double-J stent placement, failure to access the stone, and basket use, will be recorded by the research team.

To assess the impact of ureteroscope size on surgical stress, the operating surgeon's stress levels will be evaluated immediately before and after the procedure using the six-item short-form of the State Scale of the Spielberger State-Trait Anxiety Inventory (STAI).

Postoperatively, all patients undergoing ureteroscopic lithotripsy will undergo a supine direct abdominal radiograph on postoperative day 1, as per routine clinical practice. Stone-free status will be determined based on this radiograph and recorded by the investigator. Throughout the study period, no modifications to standard clinical procedures will be made.

Eligibility criteria: 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

Primary outcomes:
measure: The number of patients evaluated by postoperative X-ray with no urinary stones detected.
timeFrame: From enrollment to the end of treatment at 2 days
Secondary outcomes:
measure: The secondary objective of this study was to assess the surgeon's stress levels during the operation.
timeFrame: From enrollment to the end ofsurgery at 2 hours
Other outcomes:
Locations:
Study officials:
affiliation: Aydin Adnan Menderes University
name: GÖKHAN ŞAHİN
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.