Ureteral Stones, Ureteroscopic Lithotripsy
Conditions
Keywords
ureteral stone, anxiety inventory, ureteroscoppic lithotripsy, ureteroscop
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 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.
Interventions
PROCEDUREendoscopic ureteric lithotripsy
2 different sizes of ureteroscopes, 4.5/6.5f and 8/9.8f, will be used in the study.
Sponsors
Aydin Adnan Menderes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in STAI-TX1 Score (Postoperative - Preoperative) | Immediately before and immediately after the procedure | 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. |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRGÖKHAN ŞAHİN
Aydin Adnan Menderes University
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 65 |
| other Total, other adverse events | 6 / 65 | 15 / 65 |
| serious Total, serious adverse events | 0 / 65 | 0 / 65 |
Outcome results
None listed