Ureteroscopy, Urolithiasis
Conditions
Keywords
flexible ureteroscope, ureteral guide sheath
Brief summary
Observation efficacy and safety of disposable f7.5 electronic flexible ureteroscope combined f10 ureteral guide sheath for treatment of renal stone \<2cm.
Detailed description
Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral guide sheath to treat renal stone \<2cm, and investigating its efficacy and safety.
Interventions
DEVICEUsing disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cm
Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone \<2cm
Sponsors
Ningbo No. 1 Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with kidney stones less than 2cm who choose to perform Flexible ureteroscopic holmium laser lithotripsy; 2. Over 18 years old, male or female; 3. No hydronephrosis or mild to moderate hydronephrosis (collection system separation is less than 2cm); 4. The subject has no mental illness or language dysfunction, can understand the situation of this study and has signed an informed consent form, and is estimated to be able to cooperate with the completion of the entire study; 5. No urinary tract infection or no clinical manifestations of urinary tract infection; 6. Patients with urinary tract infection, negative urine culture, and no fever need to undergo antibiotic treatment for more than 3 days; urinary routine examination suggests urinary tract infection, positive urine culture, and patients without fever need to undergo antibiotic treatment for more than 7 days, till the urine culture turns negative.
Exclusion criteria
1. Patients with a previous history of ureteral stenosis or who have undergone open, laparoscopic ureteral, nephrectomy and lithotripsy; 2. Fever or urinary tract infection is not treated according to the inclusion criteira; 3. Pregnant women and women's menstrual periods; 4. Cannot tolerate anaesthesia or surgery due to serious systemic diseases, heart disease, lung insufficiency and failure of important organs; 5. Anatomical malformations such as polycystic kidneys, horseshoe kidneys, and ectopic kidneys; 6. Patients with high suspicion of ureteral stenosis or diseases that are considered unsuitable to participate in this clinical study; 7. Patients indwelling double J stent preoperatively; 8. Patients who need bilateral upper urinary tract surgery at the same time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of Accessing | 1 day | success rate of UAS placement (SRUP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of intraoperative ureteral injury | 1 day | Evaluation of intraoperative ureteral injury according to the standards proposed by Traxer et. al. |
| Stone free rate | 1 and 30 days | stone free rate (SFR) |
| overactive bladder symptom score (OABSS) | 1 month | Overactive bladder symptom score (OABSS) before and after the operation |
| Quality of life (QOL) questionnaire | 1 month | Quality of life (QOL) before and after the operation |
Countries
China
Outcome results
None listed