NCT03919227

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

April 15, 2019

Last Update Submit

April 15, 2019

Conditions

Urolithiasis

Keywords

RIRSUpper urinary calculiUreteral access sheathBladder filling degreeUreteral injury

Outcome Measures

Primary Outcomes (1)

  • 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.

    intraoperatively

Secondary Outcomes (3)

  • Ureteral lesion grade

    intraoperatively

  • resistance of UAS insertion

    intraoperatively

  • Complication rate

    1 month after removing the pigtail stent

Study Arms (2)

Group 1: empty bladder

EXPERIMENTAL

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

Procedure: empty bladder before inserting UAS

Group 2: natural state of bladder

ACTIVE COMPARATOR

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

Interventions

empty bladder before inserting UASPROCEDURE

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.

Group 1: empty bladder
do not interfere with the filling degree of bladderPROCEDURE

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.

Group 2: natural state of bladder

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510230, China

RECRUITING

MeSH Terms

Conditions

UrolithiasisUrinary Calculi

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Guohua Zeng, Ph.D and M.D

    The First Affiliated Hospital of Guangzhou Medical University

    STUDY CHAIR

Central Study Contacts

Guohua Zeng, Ph.D and M.D

CONTACT

+8613802916676gzgyzgh@vip.tom.com

Wen Zhong, Ph.D and M.D

CONTACT

+8613631320020gzgyzhongwen@163.com

Study Design

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

Study Record Dates

First Submitted

April 15, 2019

First Posted

April 18, 2019

Study Start

September 12, 2018

Primary Completion

April 1, 2020

Study Completion

June 1, 2020

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

CN(1)