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7.5F Versus 9.2F Flexible Ureteroscopy for the Treatment of 1-2cm Renal Calculi on Postoperative Infection

7.5F Versus 9.2F Flexible Ureteroscopy for the Treatment of 1-2cm Renal Calculi on Postoperative Infection:An International Multicenter Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05231577
Enrollment
80
Registered
2022-02-09
Start date
2022-02-01
Completion date
2022-08-31
Last updated
2022-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Stones

Keywords

ureteroscopy, postoperative fever, renal calculi

Brief summary

Ureteroscopic lithotripsy (RIRS) is the first-line treatment for 1-2 cm upper urinary tract stones, and the stone clearance rate can reach 81.4% - 92.5%. Fever after RIRS is the most common infection after RIRS, and its incidence is up to 20%. The incidence rate of systemic inflammatory response syndrome is 6.5% - 10.3%, sepsis 0.1% - 4.3%, with the infection progressed. If there is no timely and effective intervention in the early stage of urogenic sepsis, it can progress to septic shock, and the mortality can be as high as 30% - 40%. High intrarenal pressure is an important risk factor for postoperative infection. American Urological Association (AUA) guidelines point out that controlling intrarenal pressure at an appropriate level is particularly important to prevent postoperative infection. The use of ureteroscopic sheath in ureteroscopic surgery can effectively reduce the intrarenal pressure, which is an important measure to reduce the incidence of postoperative infection. Theoretically, the larger the space, the better the reflux effect and the lower the incidence of postoperative infection. The study showed that the incidence of ureteral sheath infection was significantly lower than that of ureteral sheath infection after operation. When using the same caliber ureteroscopic sheath, use a smaller caliber ureteroscopy to increase the space between the ureteroscopy and the ureteral sheath, promote reflux, reduce intrarenal pressure and reduce the incidence of postoperative infection. However, there is still a lack of relevant research on the effect of different caliber ureteroscopy in the treatment of renal calculi on postoperative infection.

Interventions

PROCEDURE7.5fr ultra-fine ureteroscopy

The patient placed the lithotomy position, placed the ureteroscope to explore the affected ureter, retrogradely placed the guide wire, and placed the 12 / 14fr ureteral sheath under X-ray monitoring until the affected ureter was close to the outlet of the renal pelvis. Group 1 patients used 7.5fr ultra-fine ureteroscopy

PROCEDURE9.2fr Ureteroscopy

The patient placed the lithotomy position, placed the ureteroscope to explore the affected ureter, retrogradely placed the guide wire, and placed the 12 / 14fr ureteral sheath under X-ray monitoring until the affected ureter was close to the outlet of the renal pelvis. Group 2 patients used 9.2fr Ureteroscopy

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Agree to receive ureteroscopy 2. Aged 18-70 years. 3.1-2cm kidney stones

Exclusion criteria

1. Combined with middle and lower ureteral calculi, surgical operation other than RIRS is required; 2. Patients with abnormal anatomical structure, ureteral stenosis and urinary diversion, such as ectopic kidney, horseshoe kidney and duplicate kidney; 3. Patients who have undergone nephrostomy; 4. Severe cardiopulmonary insufficiency; 5. Pregnant women.

Design outcomes

Primary

MeasureTime frameDescription
postoperative fever≤ 1month postoperativelyPostoperative fever was defined as armpit temperature ≥38C

Secondary

MeasureTime frameDescription
Stone free rate (SFR)1 month after removing the pigtail stent2mm Non-contrast CT is obtained for all patients at one month after removing the pigtail stent to evaluate the final SFR. Stone-free status are defined as either the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the kidney which were definded as ≤ 4mm, asymptomatic, non-obstructive and non-infectious stone particles

Countries

China

Contacts

Primary ContactGuohua Zeng, Ph.D & MD
gzgyzgh@vip.sina.com+86 13802916676
Backup ContactWen Zhong, Ph.D & MD
gzgyzhongwen@163.com+86 13631320020

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026