Comparison of 4.5/6.5F and 7.5/9.5F Ureteroscopes in Endoscopic Ureteral Stone Treatment
NCT ID: NCT06935500
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2025-07-10
2025-11-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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4,5/6,5f URS
Group operated with 4.5/6.5f ureteroscope
endoscopic ureteric lithotripsy
2 different sizes of ureteroscopes, 4.5/65f and 7.5/9.5f, will be used in the study.
7,5/9,5f URS
Group operated with 7.5/9.5f ureteroscope
endoscopic ureteric lithotripsy
2 different sizes of ureteroscopes, 4.5/65f and 7.5/9.5f, will be used in the study.
Interventions
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endoscopic ureteric lithotripsy
2 different sizes of ureteroscopes, 4.5/65f and 7.5/9.5f, will be used in the study.
Eligibility Criteria
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Inclusion Criteria
* Use of Ho:YAG laser in ureteric lithotripsy
* Patient's acceptance to participate in the study
Exclusion Criteria
* Emergency operation of the patient
* Presence of bilateral ureteral calculi
* Patient refusal to participate in the study
18 Years
75 Years
ALL
No
Sponsors
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Aydin Adnan Menderes University
OTHER
Responsible Party
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Gökhan Şahin
Principal Investigator
Principal Investigators
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GÖKHAN ŞAHİN
Role: STUDY_CHAIR
Aydin Adnan Menderes University
Locations
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Aydın State Hospital
Aydin, Aydın, Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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decision:14 protocol no: 2025/
Identifier Type: -
Identifier Source: org_study_id
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