54 Participants NeededMy employer runs this trial

Patient Positioning for Ureter Stones

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different body positions during surgery to determine which one makes the procedure for treating ureteral stones quicker and easier. The Reverse Trendelenburg Position aims to treat the stones in their current location, while the T-Tilt Position moves the stones into the kidney for treatment. The trial focuses on reducing the time needed to complete the surgery. Individuals with kidney stones larger than 1 cm or multiple stones scheduled for a specific type of surgery might be suitable for this study. As an unphased trial, it offers participants the chance to contribute to innovative surgical techniques that could enhance future procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these positioning techniques are safe for ureter stone management?

Research has shown that the Reverse Trendelenburg position during kidney stone procedures is generally safe for patients. Studies have found that this position helps prevent stones from moving to harder-to-reach areas, making the procedure quicker and more effective.

In terms of safety, the Reverse Trendelenburg position is well-tolerated. A review of multiple studies found a success rate of up to 94.3% for treating stones, indicating both effectiveness and safety for patients.

For the T-Tilt position, specific safety data is less available. However, similar positions are generally considered safe and are commonly used in medical procedures. Both positions aim to improve kidney stone treatment without adding significant risk to the patient.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative patient positioning techniques for managing ureter stones. Unlike standard treatments that typically involve medication or surgery to remove or break down stones, this trial investigates how different body positions during ureteroscopic lithotripsy might reduce complications. The Reverse Trendelenburg Position aims to minimize the migration of stones by altering the angle of the body, while the T-Tilt Position seeks to relocate stones into the kidney for potentially easier removal. By experimenting with these positions, researchers hope to improve the effectiveness and safety of ureter stone treatment.

What evidence suggests that these positioning techniques are effective for managing ureteral stones?

In this trial, participants will assume one of two positions during ureteroscopic procedures. Research has shown that the Reverse Trendelenburg position can prevent kidney stones from migrating within the ureter, potentially shortening surgery time and reducing the need for additional treatments. Conversely, the T-Tilt position involves intentionally moving the stone into the kidney before performing intrarenal lithotripsy, aiding in stone clearance. Both methods aim to expedite the procedure and enhance success by addressing different challenges in stone removal.13678

Who Is on the Research Team?

MG

Mantu Gupta, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults 18 and older who have kidney or ureter stones larger than 1 cm, or multiple stones, and are scheduled for a specific type of stone removal procedure. Participants must be able to give informed consent.

Inclusion Criteria

* Able and willing to provide informed consent.
I am 18 years old or older.
I have kidney stones and am scheduled for fURS surgery.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ureteroscopic lithotripsy in either reverse Trendelenburg or T-tilt positioning to manage proximal ureteral stones

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessment of stone-free status and complications

6 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Reverse Trendelenburg Position
  • T-Tilt Position

Trial Overview

The study compares two patient positions during surgery for upper ureteral stones: the Reverse Trendelenburg position (treating the stone where it is) versus moving the stone into the kidney and using T-tilt position. The main goal is to see which method makes surgery faster.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Reverse Trendelenburg PositionExperimental Treatment1 Intervention
Group II: T-Tilt PositionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39348719/

Impact of Either Trendelenburg or Reverse ...

Adjusting patient positioning during ureteroscopic laser lithotripsy can enhance procedure outcomes. RevTren effectively reduces ureteral stone migration ...

A Systematic Review and Meta-Analysis | Journal of Urology

This meta-analysis assesses the effectiveness of alternative surgical positioning, Reverse Trendelenburg (RevTren) and Trendelenburg (Tren), in reducing stone ...

Ureteroscopic Lithotripsy in the Reverse Trendelenburg ...

This study investigated a previously unassessed operating position for ureteroscopic holmium laser lithotripsy in patients with upper ureteral stone.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37051709/

Reverse Trendelenburg Positioning Minimizes Stone ...

RT positioning during URSLL for ureteral stones significantly decreases the rate of stone retropulsion, operative time, and the need for conversion.

pd26-08 impact of reverse trendelenburg position on ...

Minimizing retropulsion may improve surgical efficiency during ureteroscopic lithotripsy. This study seeks to determine if reverse Trendelenburg ...

Reverse Trendelenburg Lithotomy with Certain Inclination ...

The objective of this study is to investigate how different inclination angles of reverse Trendelenburg lithotomy affect stone retropulsion and stone-free ...

A Systematic Review and Meta-Analysis.

This meta-analysis assesses the effectiveness of alternative surgical positioning, Reverse Trendelenburg (RevTren) and Trendelenburg (Tren) ...

Reverse Trendelenburg Positioning Minimizes Stone ...

This study indicates that RT positioning is an effective strategy for reducing ureteral stone retropulsion, which can also result in a subsequent reduction in ...