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

Primary Purpose

Kidney Stones

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
7.5fr ultra-fine ureteroscopy
9.2fr Ureteroscopy
Sponsored by
The First Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stones focused on measuring ureteroscopy, postoperative fever, renal calculi

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

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

Experimental: Patients in Group 2 undergo 9.2fr ureteroscopy

Arm Description

Outcomes

Primary Outcome Measures

postoperative fever
Postoperative fever was defined as armpit temperature ≥38C

Secondary Outcome Measures

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

Full Information

First Posted
January 31, 2022
Last Updated
January 31, 2022
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05231577
Brief Title
7.5F Versus 9.2F Flexible Ureteroscopy for the Treatment of 1-2cm Renal Calculi on Postoperative Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones
Keywords
ureteroscopy, postoperative fever, renal calculi

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Patients in Group 0 undergo 7.5fr ultra-fine ureteroscopy
Arm Type
Experimental
Arm Title
Experimental: Patients in Group 2 undergo 9.2fr ureteroscopy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
7.5fr ultra-fine ureteroscopy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
9.2fr Ureteroscopy
Intervention Description
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
Primary Outcome Measure Information:
Title
postoperative fever
Description
Postoperative fever was defined as armpit temperature ≥38C
Time Frame
≤ 1month postoperatively
Secondary Outcome Measure Information:
Title
Stone free rate (SFR)
Description
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
Time Frame
1 month after removing the pigtail stent

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guohua Zeng, Ph.D & MD
Phone
+86 13802916676
Email
gzgyzgh@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Zhong, Ph.D & MD
Phone
+86 13631320020
Email
gzgyzhongwen@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, Ph.D & MD
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, Minimally invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong,China
ZIP/Postal Code
510230
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, Ph.D & MD
Phone
+8613802916676
Email
gzgyzgh@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Wen Zhong, Ph.D & MD
Phone
+8613631320020
Email
gzgyzhongwen@163.com
First Name & Middle Initial & Last Name & Degree
Wen Zhong

12. IPD Sharing Statement

Citations:
PubMed Identifier
9146583
Citation
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.
Results Reference
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7.5F Versus 9.2F Flexible Ureteroscopy for the Treatment of 1-2cm Renal Calculi on Postoperative Infection

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