Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4,5/6,5f URS | Group operated with 4.5/6.5f ureteroscope |
| |
| 8/9,8f URS | Group operated with 8/9.8f ureteroscope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic ureteric lithotripsy | Procedure | 2 different sizes of ureteroscopes, 4.5/6.5f and 8/9.8f, will be used in the study. |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients between 18-75 years of age who applied to the urology outpatient clinic and were planned for elective endoscopic ureteral stone operation
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GÖKHAN ŞAHİN | Aydin Adnan Menderes University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aydın State Hospital | Aydin | Aydın | 09100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25406932 | Background | 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. | |
| 36208314 | 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. |
Not provided
Not provided
It is not planned to share individual participant data unless specifically requested by the journal in which the study will be published.
Not provided
Not provided
Not provided
Not provided
Patients were divided into two groups using a simple 1:1 randomization method. Patients scheduled for ureteroscopy were evaluated for participation in the study, and those who underwent ureteroscopy were included. There is no missing data.
After obtaining local ethics committee approval, patients who presented to the urology pool clinic with ureteral stones and were scheduled for ureteroscopy were included in the study. Following the latest gpower analysis, it was decided to include 65 patients in each of the two groups.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 4,5/6,5f URS Group | group in which 4.5/6.5f ureteroscope was used during ureteroscopy surgery. |
| FG001 | 8/9,8f URS | Group operated with 8/9.8f ureteroscope |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There is no missing data in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 4,5/6,5f URS Group | group in which 4.5/6.5f ureteroscope was used during ureteroscopy surgery. |
| BG001 | 8/9,8f URS | Group operated with 8/9.8f ureteroscope |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants were included in the analysis. The analysis population corresponds to the total number of participants assigned to each group (n=65 per group). | Posted | Mean | Standard Deviation | Scores on a scale | Immediately before and immediately after the procedure |
|
From the start of the procedure until hospital discharge (typically within 1-2 days postoperatively)
Adverse events were prospectively recorded during the intraoperative and postoperative periods. Complications were classified according to the Traxer classification for ureteral injury and the Clavien-Dindo classification for postoperative complications. All adverse event data are reported in the corresponding tables.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4,5/6,5f URS | Group operated with 4.5/6.5f ureteroscope | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild hematuria | Renal and urinary disorders | Systematic Assessment | Postoperative mild hematuria observed during the early postoperative period and managed conservatively (Clavien-Dindo grade I). |
No interpretative statements are provided in this section. All results are presented in the corresponding outcome measure data tables.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gökhan Şahin, MD | Aydın State Hospital , Aydın, Turkey | +905543924200 | gokhansahinn7510@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 25, 2026 | Mar 25, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D053039 | Ureterolithiasis |
| ID | Term |
|---|---|
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
| 30534443 | 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. |
| 24035032 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Sex was recorded as reported in the patients' medical records at the time of enrollment and categorized as male or female. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| 4,5/6,5f URS |
Group operated with 4.5/6.5f ureteroscope |
| OG001 | 8/9,8f URS | Group operated with 8/9.8f ureteroscope |
|
|
| 65 |
| 0 |
| 65 |
| 6 |
| 65 |
| EG001 | 8/9,8f URS | Group operated with 8/9.8f ureteroscope | 0 | 65 | 0 | 65 | 15 | 65 |
|
| renal colic | Renal and urinary disorders | Systematic Assessment | Postoperative renal colic requiring analgesic treatment without further intervention (Clavien-Dindo grade I- |
|
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |