Comparison of Vacuum-Assisted and Conventional Ureteral Access Sheath in Retrograde Intrarenal Surgery

NCT06684756 | Active Not Recruiting

• 1 other identifier: 2024.288.10.16
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy and safety, the ratio of stone-free rates, and complications of two types of access sheaths used in retrograde intrarenal surgery to treat upper urothelial stones. The access sheath types are those with vacuum aspiration and the conventional ones.

Conditions

Kidney Calculi; Kidney Stones

Keywords

kidney stone; retrograde intrarenal surgery; ureteral access sheath; vacuum assisted

Outcome Measures

Primary Outcomes (1)

• Stone free rates

  Presence/absence of residual fragments in postoperative imaging, if any, diameter of longest axis in mm.

  Stone-free status will be checked by performing a non-contrast abdominal CT scan 1 month after the operation.

Secondary Outcomes (1)

• Complication rates

  Peroperative complication rates will be determined during the operation, and postoperative complications will be re-evaluated during hospitalization before discharge or in the first month after discharge.

Study Arms (2)

Patients with conventional UAS being used in their RIRS operations

ACTIVE COMPARATOR

The patient population will be selected from cases determined by randomization and used with UAS without an aspiration (conventional) during RIRS.

Procedure: Retrograde intrarenal surgery

Patients with vacuum assisted UAS being used in their RIRS operations

EXPERIMENTAL

The patient population will be selected from cases determined by randomization and used with UAS with an aspiration and flexible tip, different from the conventional one during RIRS.

Procedure: Retrograde intrarenal surgery

Interventions

Retrograde intrarenal surgery PROCEDURE

Flexible optic devices and lasers fragment kidney stones during this operation. In this surgery, an ureteral access sheath is recommended to be used.

Patients with conventional UAS being used in their RIRS operations; Patients with vacuum assisted UAS being used in their RIRS operations

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age
• Patients below 85 years of age
• Patients with 11-13 FR conventional/vacuum-assisted ureteral access sheath (UAS) during retrograde intrarenal surgery

You may not qualify if:

• Patients with non-sterile preoperative urine culture
• Patients with renal anatomic anomalies
• Patients with a solitary (single) kidney
• Patients with insufficient data
• Patients under the age of 18, above the age of 85
• Patients without an UAS during RIRS
• Patients without 11-13Fr UAS during RIRS

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (1)

Tekirdag Namık Kemal University

Tekirdağ, Turkey, Turkey (Türkiye)

Location

Related Publications (4)

• Wang D, Xu Y, Liu Z, Liang J, Lai D, Guan W, Xu G. Using vacuum-assisted ureteral access sheath in the treatment of complex steinstrasse. Urolithiasis. 2023 Jun 22;51(1):89. doi: 10.1007/s00240-023-01462-2.

  PMID: 37347309 BACKGROUND

• Zhang Z, Xie T, Li F, Wang X, Liu F, Jiang B, Zou X, Zhang G, Yuan Y, Xiao R, Wu G, Qian B. Comparison of traditional and novel tip-flexible suctioning ureteral access sheath combined with flexible ureteroscope to treat unilateral renal calculi. World J Urol. 2023 Dec;41(12):3619-3627. doi: 10.1007/s00345-023-04648-w. Epub 2023 Oct 11.

  PMID: 37821778 BACKGROUND

• Nao T, Iga R, Yoshimura R, Kurano Y, Yamamoto S, Tamura K. A new method for effective use of the ClearPetra ureteral access sheath for a giant ureteral stone. Urol Case Rep. 2023 Oct 23;51:102599. doi: 10.1016/j.eucr.2023.102599. eCollection 2023 Nov.

  PMID: 38024505 BACKGROUND

• Gauhar V, Traxer O, Castellani D, Sietz C, Chew BH, Fong KY, Hamri SB, Gokce MI, Gadzhiev N, Galosi AB, Yuen SKK, El Hajj A, Ko R, Zawadzki M, Sridharan V, Lakmichi MA, Corrales M, Malkhasyan V, Ragoori D, Soebhali B, Tan K, Chai CA, Tursunkulov AN, Tanidir Y, Persaud S, Elshazly M, Kamal W, Tefik T, Shrestha A, Tiong HC, Somani BK. Could Use of a Flexible and Navigable Suction Ureteral Access Sheath Be a Potential Game-changer in Retrograde Intrarenal Surgery? Outcomes at 30 Days from a Large, Prospective, Multicenter, Real-world Study by the European Association of Urology Urolithiasis Section. Eur Urol Focus. 2024 Dec;10(6):975-982. doi: 10.1016/j.euf.2024.05.010. Epub 2024 May 24.

  PMID: 38789313 RESULT

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Cenk M. Yazici, Professor

  Namik Kemal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 20, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)