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Under Direct Vision vs Under Non Direct Vision of Insertion of UAS in RIRS

NCT03717285 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2018-10-24

No results posted yet for this study

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 many ureteral injuries occur during UAS insertion of the ureter from ureteral orifice. And if we use rigid ureteroscopy to insert the UAS under direct vision, we can provide the placement success rate and reduce the incidence of complications. The investigator aims to perform a prospective and randomized controlled trial comparing the safety and efficacy of under direct vision and under non direct vision during the insertion of UAS.

Conditions

  • Urolithiasis

Interventions

PROCEDURE

Insert the UAS under direct vision

Patients in this group，we use rigid ureteroscopy to insert the UAS under direct vision.

PROCEDURE

Insert the UAS under non direct vision

Patients in this group，we insert the UAS by the experience of the surgeon and under non direct vision .

Sponsors & Collaborators

  • Guohua Zeng

    lead OTHER

Principal Investigators

  • Guohua Zeng, Ph.D and M.D · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-10
Primary Completion
2019-09-10
Completion
2019-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03717285 on ClinicalTrials.gov