Measurement of Resistance During UAS Insertion Procedure in RIRS

April 15, 2019 updated by: Guohua Zeng

Measurement of Resistance During UAS Insertion Procedure in RIRS: the Effects of Bladder Filling Degree and the Assessment of Ureter Injury.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510230
        • Recruiting
        • Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: empty bladder
In group 1, investigator empty the bladder of urine with a catheter before inserting UAS.
Procedure: empty bladder before inserting UAS
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.
Active Comparator: Group 2: natural state of bladder
In group 2, investigator does not interfere with the filling degree of bladder before inserting UAS.
Procedure: do not interfere with the filling degree of bladder
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UAS insertion success rate
Time Frame: intraoperatively
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.
intraoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ureteral lesion grade
Time Frame: intraoperatively
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.
intraoperatively
resistance of UAS insertion
Time Frame: intraoperatively
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.
intraoperatively
Complication rate
Time Frame: 1 month after removing the pigtail stent
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
1 month after removing the pigtail stent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guohua Zeng

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2018

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

April 15, 2019

First Posted (Actual)

April 18, 2019

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRER(78)2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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