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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-10

Study Completion Date

2025-11-15

Brief Summary

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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

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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.

Conditions

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Ureteral Stones Ureteroscopic Lithotripsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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4,5/6,5f URS

Group operated with 4.5/6.5f ureteroscope

endoscopic ureteric lithotripsy

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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Gökhan Şahin

Principal Investigator

Responsibility Role 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)

Site Status

Countries

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Turkey (Türkiye)

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.

Reference Type RESULT
PMID: 25406932 (View on PubMed)

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.

Reference Type RESULT
PMID: 36208314 (View on PubMed)

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.

Reference Type RESULT
PMID: 30534443 (View on PubMed)

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.

Reference Type RESULT
PMID: 24035032 (View on PubMed)

Other Identifiers

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decision:14 protocol no: 2025/

Identifier Type: -

Identifier Source: org_study_id

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