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

NCT03717285 | Unknown

• 1 other identifier: MRER(75)2018
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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 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

Keywords

RIRS; Renal stones; ureteral access sheath; ureteral injury

Outcome Measures

Primary Outcomes (1)

• UAS insertion success rate

  Primary insertion of a UAS is not always possible. 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 (2)

• Complication rate

  1 month after removing the pigtail stent

• Ureteral lesion grade

  intraoperatively

Study Arms (2)

Group 1:Under direct vision

EXPERIMENTAL

Patients in Group 1 insert the UAS under direct vision.In this procedure,the investigators will insert the ureteroscope into urinary bladder beside the guidewire to observe the process of uas insertion into the ureter.

Procedure: Insert the UAS under direct vision

Group 2:Under non direct vision

ACTIVE COMPARATOR

Patients in Group 2 insert the UAS under non direct vision.In this procedure,the investigators will insert the UAS under fluoroscopy control.

Procedure: Insert the UAS under non direct vision

Interventions

Insert the UAS under direct vision PROCEDURE

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

Group 1:Under direct vision

Insert the UAS under non direct vision PROCEDURE

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

Group 2:Under non direct vision

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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:

• Patients with solitary kidney
• Uncorrected coagulopathy and active urinary tract infection (UTI)
• Prior ipsilateral endourological procedure history, such as RIRS, PCNL, URS and URL
• Patients who underwent transplant or urinary diversion.
• Congenital abnormalities.

Sponsors & Collaborators

• Guohua Zeng: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510230, China

RECRUITING

MeSH Terms

Conditions

Urolithiasis; Nephrolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases

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

+86 13802916676; gzgyzgh@vip.tom.com

Guangming Chen

CONTACT

+8613246888213; 1172676107@qq.com

Study Design

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

Study Record Dates

• First Submitted: October 7, 2018
• First Posted: October 24, 2018
• Study Start: September 10, 2018
• Primary Completion: September 10, 2019
• Study Completion: December 31, 2019
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

CN (1)