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

NCT05231577 | Unknown

• 1 other identifier: RCT(2022)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stones

Keywords

ureteroscopy; postoperative fever; renal calculi

Outcome Measures

Primary Outcomes (1)

• postoperative fever

  Postoperative fever was defined as armpit temperature ≥38C

  ≤ 1month postoperatively

Secondary Outcomes (1)

• Stone free rate (SFR)

  1 month after removing the pigtail stent

Study Arms (2)

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

EXPERIMENTAL

Procedure: 7.5fr ultra-fine ureteroscopy

Experimental: Patients in Group 2 undergo 9.2fr ureteroscopy

EXPERIMENTAL

Procedure: 9.2fr Ureteroscopy

Interventions

7.5fr ultra-fine ureteroscopy PROCEDURE

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

9.2fr Ureteroscopy PROCEDURE

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

Experimental: Patients in Group 2 undergo 9.2fr ureteroscopy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

Department of Urology, Minimally invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong,China, 510230, China

Location

Related Publications (2)

• 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. doi: 10.1016/s0022-5347(01)64677-9.

  PMID: 9146583 BACKGROUND

• Zhong W, Zhu W, Zhao Z, Liao B, Mai H, Liu C, Wang K, Zhang X, Xu C, Zeng G. 7.5F Mini Flexible Ureteroscope in Retrograde Intrarenal Surgery: Initial Results from a Multicenter Randomized Clinical Trial. J Endourol. 2024 May;38(5):421-425. doi: 10.1089/end.2023.0540. Epub 2024 Apr 4.

  PMID: 38299514 DERIVED

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Guohua Zeng, Ph.D & MD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guohua Zeng, Ph.D & MD

CONTACT

+86 13802916676; gzgyzgh@vip.sina.com

Wen Zhong, Ph.D & MD

CONTACT

+86 13631320020; gzgyzhongwen@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 9, 2022
• Study Start: February 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-01

Locations

CN (1)