Effect of Tidal Volume on fURS Parameters

NCT ID: NCT07304297

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2025-11-24

Brief Summary

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The goal of this prospective clinical trial is to evaluate how intraoperative tidal volume settings affect surgical parameters and outcomes in adult patients undergoing flexible ureteroscopy (fURS) for kidney stones. The participant population includes patients over 18 years of age with unilateral, single renal stones located in the upper/middle calyx or renal pelvis.

This study aims to answer are:

Does intraoperative tidal volume influence operative time and surgical efficiency during fURS?

Does tidal volume affect laser energy use, lasing efficiency, stone-free rates, and complication rates (infection or bleeding)?

The investigators will compare two groups based on tidal volume recorded during anaesthesia:

Group 1: Low tidal volume (\< 500 mL)

Group 2: Standard tidal volume (≥ 500 mL)

to determine whether tidal volume differences impact surgical performance and postoperative outcomes.

Participants will:

Undergo fURS performed under general anaesthesia with standard ASA monitoring, including ETCO₂ and TOF monitoring.

Have their respiratory parameters (tidal volume, peak airway pressure, PEEP, respiratory rate, ETCO₂) and surgical data (operative time, laser settings, fluoroscopy use, stone-free status) recorded during and after surgery.

Detailed Description

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Conditions

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Urolithiasis Tidal Volume Flexible Ureteroscopy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low Tidal Volume

Group Type ACTIVE_COMPARATOR

Flexible Ureteroscopy

Intervention Type PROCEDURE

Between October 2025 and December 2025, Patients who underwent fURS surgery in our clinic, with the surgical indication determined according to the EAU guidelines, were included in the study. Patients over 18 years of age with unilateral, single stones located in the upper or middle calyx or in the renal pelvis were included in the study. Patients with chronic obstructive pulmonary disease, pregnancy, a history of abdominal, retroperitoneal, or thoracic surgery, kidney anomalies, or stones located in the lower calyx were excluded.

Normal Tidal Volume

Group Type PLACEBO_COMPARATOR

Flexible Ureteroscopy

Intervention Type PROCEDURE

Between October 2025 and December 2025, Patients who underwent fURS surgery in our clinic, with the surgical indication determined according to the EAU guidelines, were included in the study. Patients over 18 years of age with unilateral, single stones located in the upper or middle calyx or in the renal pelvis were included in the study. Patients with chronic obstructive pulmonary disease, pregnancy, a history of abdominal, retroperitoneal, or thoracic surgery, kidney anomalies, or stones located in the lower calyx were excluded.

Interventions

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Flexible Ureteroscopy

Between October 2025 and December 2025, Patients who underwent fURS surgery in our clinic, with the surgical indication determined according to the EAU guidelines, were included in the study. Patients over 18 years of age with unilateral, single stones located in the upper or middle calyx or in the renal pelvis were included in the study. Patients with chronic obstructive pulmonary disease, pregnancy, a history of abdominal, retroperitoneal, or thoracic surgery, kidney anomalies, or stones located in the lower calyx were excluded.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Age ≥18 years

Unilateral, single kidney stones located in the upper or middle calyx or in the renal pelvis

Exclusion Criteria

Chronic obstructive pulmonary disease (COPD)

Pregnancy

History of abdominal, retroperitoneal, or thoracic surgery

Kidney anomalies

Stones located in the lower calyx
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tarik Emre Sener

OTHER

Sponsor Role lead

Responsible Party

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Tarik Emre Sener

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Marmara University School of Medicine Urology Department

Istanbul, Pendik, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MAR.UAD.0026

Identifier Type: -

Identifier Source: org_study_id