Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07516535

DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones

Kidney stones are a common health problem and may recur frequently, which can affect quality of life and kidney function. Retrograde intrarenal surgery (RIRS) is a minimally invasive treatment used for renal stones, but treatment of medium-sized stones may be associated with longer operative time, impaired visibility during surgery, residual stone fragments, and postoperative infectious complications caused by increased intrarenal pressure.

Suction-assisted retrograde intrarenal surgery (RIRS) techniques have been developed to improve surgical efficiency and safety by facilitating continuous removal of stone fragments and helping control intrarenal pressure. Two commonly used suction-assisted approaches are direct in-scope suction (DISS) and flexible and navigable suction ureteric access sheath (FANS). However, there is limited prospective randomized evidence directly comparing these two techniques.

This randomized prospective clinical study aims to compare direct in-scope suction (DISS) versus flexible and navigable suction ureteric access sheath (FANS) in adult patients with medium-sized renal stones measuring 2 to 3 cm who are undergoing retrograde intrarenal surgery (RIRS). Participants will be randomly assigned to one of the two suction-assisted techniques. The study will evaluate whether flexible and navigable suction ureteric access sheath (FANS) provides better outcomes than direct in-scope suction (DISS) in terms of stone-free rate and postoperative infection rate.

The primary outcome is stone-free status assessed by postoperative imaging. Secondary outcomes include operative time, intraoperative visibility, and postoperative complications, particularly infection and urosepsis. The study hypothesis is that suction-assisted retrograde intrarenal surgery (RIRS) using the flexible and navigable suction ureteric access sheath (FANS) technique will result in a higher stone-free rate and a lower postoperative infection rate compared with direct in-scope suction (DISS) in the management of medium-sized renal stones.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 to 60 years
  • Radiologically confirmed renal stones measuring 2 to 3 centimeters
  • Eligible for retrograde intrarenal surgery
  • Normal renal function as evidenced by normal serum creatinine
  • Able and willing to provide written informed consent

Exclusion criteria

  • Pregnancy or lactation
  • Active urinary tract infection at the time of enrollment
  • Bleeding disorders or coagulopathies that contraindicate surgical intervention
  • Anatomical malformations affecting the urinary tract
  • Solitary kidney
  • Inability or unwillingness to provide informed consent

Treatment and study plan

Direct In-Scope Suction

Procedure

Direct suction is applied through the working channel of the flexible ureteroscope during retrograde intrarenal surgery to facilitate evacuation of stone fragments and improve intraoperative visibility during laser lithotripsy.

Other names: DISS

Flexible and Navigable Suction Ureteric Access Sheath

Procedure

A flexible and navigable suction ureteric access sheath is used during retrograde intrarenal surgery to provide suction-assisted evacuation of stone fragments, improve visibility, and support intrarenal pressure control during laser lithotripsy.

Other names: FANS

Primary outcomes

  1. Stone-Free Rate

    Time frame: At 1 month after surgery

    Stone-free status will be assessed by postoperative imaging using kidney, ureter, and bladder radiography and non-contrast computed tomography. Clinically insignificant residual fragments will be defined as residual fragments measuring 2 to 3 millimeters or less.

Secondary outcomes

  1. Postoperative Infection Rate

    Time frame: Within 1 month after surgery

    The proportion of participants who develop any postoperative infectious complications.

  2. Operative Time

    Time frame: During surgery (Intraoperatively)

    Operative time measured in minutes from ureteroscope insertion to successful placement of the double-J ureteral stent.

  3. Intraoperative Visibility Score

    Time frame: During surgery (Intraoperatively)

    Intraoperative visibility will be graded by the operating surgeon using a 3-point scale: grade 0 for poor visibility, grade 1 for moderate visibility, and grade 2 for good visibility.

  4. Postoperative Complication Rate

    Time frame: Within 1 month after surgery

    The proportion of participants with postoperative complications classified according to the Clavien-Dindo classification system.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed S Marey, MBBCh

CONTACT

[email protected]

01550199333 ext. +02

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Impact of Suction-Assisted RIRS (DISS Versus FANS) on Postoperative Infection Rate and Stone-Free Rate After Treatment of Medium Sized Renal Stones

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.