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

Kidney Stones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05231577
• Other study ID #: RCT(2022)
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: January 2022
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Guohua Zeng, Ph.D & MD
• Phone: +86 13802916676
• Email: gzgyzgh[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stones
• Nephrolithiasis

Intervention

Procedure:
• 7.5fr 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
• 9.2fr 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

Locations

Country	Name	City	State
China	Department of Urology, Minimally invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong,China

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Elashry OM, Elbahnasy AM, Rao GS, Nakada SY, Clayman RV. Flexible ureteroscopy: Washington University experience with the 9.3F and 7.5F flexible ureteroscopes. J Urol. 1997 Jun;157(6):2074-80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative fever	Postoperative fever was defined as armpit temperature =38C	= 1month postoperatively
Secondary	Stone free rate (SFR)	2mm 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	1 month after removing the pigtail stent