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Clinical Trials/NCT05231577
NCT05231577
Unknown
Not Applicable

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

The First Affiliated Hospital of Guangzhou Medical University1 site in 1 country80 target enrollmentFebruary 1, 2022
ConditionsKidney Stones

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kidney Stones
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Enrollment
80
Locations
1
Primary Endpoint
postoperative fever
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
August 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Responsible Party
Principal Investigator
Principal Investigator

Guohua Zeng

Vice president

The First Affiliated Hospital of Guangzhou Medical University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

postoperative fever

Time Frame: ≤ 1month postoperatively

Postoperative fever was defined as armpit temperature ≥38C

Secondary Outcomes

  • Stone free rate (SFR)(1 month after removing the pigtail stent)

Study Sites (1)

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