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Measurement of Resistance During UAS Insertion Procedure in RIRS

Primary Purpose

Urolithiasis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
empty bladder before inserting UAS
do not interfere with the filling degree of bladder
Sponsored by
Guohua Zeng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urolithiasis focused on measuring RIRS, Upper urinary calculi, Ureteral access sheath, Bladder filling degree, Ureteral injury

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients must be a suitable operative candidate for RIRS
  2. Age 18 to 70 years
  3. Normal renal function 4 .ASA score Ⅰ and Ⅱ

5. Single renal or ureteral stone ≤20mm or multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) up to 20 mm

Exclusion Criteria:

  1. Uncorrected coagulopathy and active urinary tract infection (UTI)
  2. Severe cardiopulmonary dysfunction, can not tolerate sugery
  3. Patients who underwent transplant or urinary diversion
  4. Definite diagnosis of ureteral stricture or a history of stricture
  5. The bladder volume is less than 100ml

Sites / Locations

  • Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: empty bladder

Group 2: natural state of bladder

Arm Description

In group 1, investigator empty the bladder of urine with a catheter before inserting UAS.

In group 2, investigator does not interfere with the filling degree of bladder before inserting UAS.

Outcomes

Primary Outcome Measures

UAS insertion success rate
Primary insertion of a UAS is not always successful. The ideal position of the UAS is with its distal extremity just below the ureteric-pelvic junction (UPJ). Insertion failure is defined as UAS cross the upj or do not reach the proximal ureter or the surgeon's decision to resign UAS insertion due to high resistance to the retrograde progression of the UAS along the urinary tract.

Secondary Outcome Measures

Ureteral lesion grade
Base on post-ureteroscopic lesion scale (PULS), reported by Traxer O and Thomas A in 2013. UAS related ureteral injuries were divided into 5 grades according to ureteral wall anatomy. Grade 0 means no lesion found or only mucosal petechiae. Grade 1 means ureteral mucosal erosion without smooth muscle injury. Both Grade 0 and Grade 1 are considered as low-level injuries. Grade 2 means ureteral wall injury, including mucosa and smooth muscle, with adventitial preservation (periureteral fat not seen). Grade 3 means ureteral injury indicated ureteral perforation involving the full thickness of the ureteral wall, including the adventitia. Grade 4 means injury corresponded to total ureteral avulsion with complete rupture of ureteral continuity. Grade 2, 3 and 4 are high-level injuries.
resistance of UAS insertion
The dynamometer was used to measure the resistance of UAS insertion procedure in both two groups, so as to analysis the relationship between bladder filling degree and inserting resistance.
Complication rate
Complication is defined as any adverse event occurred intraoperatively or ≤1 month postoperatively, including intraoperative bleeding, postoperative pain and so on.The investigator will invaluate perioperative complications by modified Clavien system

Full Information

First Posted
April 15, 2019
Last Updated
April 15, 2019
Sponsor
Guohua Zeng
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1. Study Identification

Unique Protocol Identification Number
NCT03919227
Brief Title
Measurement of Resistance During UAS Insertion Procedure in RIRS
Official Title
Measurement of Resistance During UAS Insertion Procedure in RIRS: the Effects of Bladder Filling Degree and the Assessment of Ureter Injury.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 12, 2018 (Actual)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guohua Zeng

4. Oversight

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

5. Study Description

Brief Summary
Retrograde intrarenal surgery (RIRS) has been considered as the first-line choice for the management of <20mm kidney stones. Insertion of a ureteral access sheath (UAS) before RIRS surgery is currently accepted as an effective method to improve the effectiveness of surgery, but can be accompanied by serious complications. In long-term clinical practice, the investigators has found that different Bladder Filling Degree was accompanied by different Resistance During UAS Insertion Procedure in RIRS, which leads to the difference in success rate of UAS insertion.The investigator aims to perform a prospective and randomized controlled trial comparing the success rate of UAS insertion procedure under different bladder filling degree,and discuss the relationship between insertion resistance and ureter injury.
Detailed Description
Upper urinary calculi is a common disease that endangers human health, Retrograde intrarenal surgery (RIRS) has been considered as the first-line choice for the management of <20mm kidney stones. Insertion of a ureteral access sheath (UAS) before RIRS surgery is currently accepted as an effective method to improve the effectiveness of surgery, for UAS can drain irrigation to reduce renal pelvic pressure and maintain vision clear. But incorrect way to insert UAS can be accompanied by serious complications. For instance, If the ureter was not dilated by DJ stent before RIRS surgery, or ureter was relatively narrow, the insertion of UAS would encounter great resistance. Sometimes the ureter was violently pushed into UAS, it might cause ureteral perforation or avulsion. As for how to insert UAS correctly, there is no unified international standard at present. Different surgeons have different experience. In long-term clinical practice, the investigators has found that different Bladder Filling Degree was accompanied by different Resistance During UAS Insertion Procedure in RIRS, which leads to the difference in success rate of UAS insertion. In addition, there seems to be some relationship between the resistance of UAS insertion and the ureter injury in surgery. Therefore, the investigator aims to perform a prospective and randomized controlled trial comparing the success rate of UAS insertion procedure under different bladder filling degree, and discuss the relationship between insertion resistance and ureter injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
RIRS, Upper urinary calculi, Ureteral access sheath, Bladder filling degree, Ureteral injury

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group 1: empty bladder
Arm Type
Experimental
Arm Description
In group 1, investigator empty the bladder of urine with a catheter before inserting UAS.
Arm Title
Group 2: natural state of bladder
Arm Type
Active Comparator
Arm Description
In group 2, investigator does not interfere with the filling degree of bladder before inserting UAS.
Intervention Type
Procedure
Intervention Name(s)
empty bladder before inserting UAS
Intervention Description
In group 1, investigator empty the bladder of urine with a catheter before inserting UAS, so that we can see if the empty bladder is easier for inserting UAS.
Intervention Type
Procedure
Intervention Name(s)
do not interfere with the filling degree of bladder
Intervention Description
In group 2, investigator does not interfere with the filling degree of bladder before inserting UAS, so that we can see if the filling degree of bladder has impact on the insertion of UAS.
Primary Outcome Measure Information:
Title
UAS insertion success rate
Description
Primary insertion of a UAS is not always successful. The ideal position of the UAS is with its distal extremity just below the ureteric-pelvic junction (UPJ). Insertion failure is defined as UAS cross the upj or do not reach the proximal ureter or the surgeon's decision to resign UAS insertion due to high resistance to the retrograde progression of the UAS along the urinary tract.
Time Frame
intraoperatively
Secondary Outcome Measure Information:
Title
Ureteral lesion grade
Description
Base on post-ureteroscopic lesion scale (PULS), reported by Traxer O and Thomas A in 2013. UAS related ureteral injuries were divided into 5 grades according to ureteral wall anatomy. Grade 0 means no lesion found or only mucosal petechiae. Grade 1 means ureteral mucosal erosion without smooth muscle injury. Both Grade 0 and Grade 1 are considered as low-level injuries. Grade 2 means ureteral wall injury, including mucosa and smooth muscle, with adventitial preservation (periureteral fat not seen). Grade 3 means ureteral injury indicated ureteral perforation involving the full thickness of the ureteral wall, including the adventitia. Grade 4 means injury corresponded to total ureteral avulsion with complete rupture of ureteral continuity. Grade 2, 3 and 4 are high-level injuries.
Time Frame
intraoperatively
Title
resistance of UAS insertion
Description
The dynamometer was used to measure the resistance of UAS insertion procedure in both two groups, so as to analysis the relationship between bladder filling degree and inserting resistance.
Time Frame
intraoperatively
Title
Complication rate
Description
Complication is defined as any adverse event occurred intraoperatively or ≤1 month postoperatively, including intraoperative bleeding, postoperative pain and so on.The investigator will invaluate perioperative complications by modified Clavien system
Time Frame
1 month after removing the pigtail stent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be a suitable operative candidate for RIRS Age 18 to 70 years Normal renal function 4 .ASA score Ⅰ and Ⅱ 5. Single renal or ureteral stone ≤20mm or multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) up to 20 mm Exclusion Criteria: Uncorrected coagulopathy and active urinary tract infection (UTI) Severe cardiopulmonary dysfunction, can not tolerate sugery Patients who underwent transplant or urinary diversion Definite diagnosis of ureteral stricture or a history of stricture The bladder volume is less than 100ml
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guohua Zeng, Ph.D and M.D
Phone
+8613802916676
Email
gzgyzgh@vip.tom.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Zhong, Ph.D and M.D
Phone
+8613631320020
Email
gzgyzhongwen@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, Ph.D and M.D
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510230
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhong Wen, Ph.D & MD.
Phone
+8613631320020
Email
gzgyzhongwen@163.com

12. IPD Sharing Statement

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Measurement of Resistance During UAS Insertion Procedure in RIRS

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