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

Sponsor

The First Affiliated Hospital of Guangzhou Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05231577

Collaborator

(none)

Enrollment

Location

Arms

6.9

Anticipated Duration (Months)

11.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stones	Procedure: 7.5fr ultra-fine ureteroscopy Procedure: 9.2fr Ureteroscopy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Patients in Group 0 undergo 7.5fr ultra-fine ureteroscopy	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
Experimental: Experimental: Patients in Group 2 undergo 9.2fr ureteroscopy	Procedure: 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

Arm

Intervention/Treatment

Experimental: Experimental: Patients in Group 0 undergo 7.5fr ultra-fine ureteroscopy

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

Experimental: Experimental: Patients in Group 2 undergo 9.2fr ureteroscopy

Procedure: 9.2fr Ureteroscopy

Outcome Measures

Primary Outcome Measures

postoperative fever [≤ 1month postoperatively]
Postoperative fever was defined as armpit temperature ≥38C

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Urology, Minimally invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong,China	China	510230