Investigate the Renal Movement by Single Lung Ventilation in Patients Administered RIRS for Kidney Stones.

NCT ID: NCT03060837

Last Updated: 2020-02-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-03-01

Brief Summary

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In patients undergoing RIRS for kidney stone, we aim to show the effect of single lung ventilation with a double lumen tube on operative (operation scope duration, perforation, hemorrhage, etc. complications) and postoperative parameters (stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc.) and to show changes in renal stone position during simultaneous normal ventilation and single lung ventilation.

Detailed Description

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In recent years open surgical treatment has changed to minimal invasive treatments for kidney stone treatment. Additionally, the treatment choices vary depending on the localization of the stone and its dimensions. In the European Urology Association (EUA) guidelines, it states the RIRS method can be used to treat stones up to 2 cm in the kidney. Due to RIRS the operation and scopy durations and hospital stay have clearly reduced compared to the standard treatment of percutaneous nephrolithotomy. However, the high hydrostatic pressure applied to the renal pelvis during RIRS may cause unwanted results in the postoperative period such as hydronephrosis and loss of renal parenchyma. During the operation, the stone may move during deep inspirium and expirium sequences linked to deep ventilation which may lengthen the operation and scope durations and brings risks such as perforation during laser lithotripsy application. In this study we aimed to apply single lung ventilation during the operation (one of the indications for single lung ventilation is to increase surgical view and ease manipulation) to minimize renal movement on that side and reduce peroperative and postoperative complications.

Conditions

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Perioperative/Postoperative Complications Kidney Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Patients given single lung ventilation

The first group will have single lung ventilation applied to ensure reduction. Preoperative Parameters : Hmg, serum creatinine levels Peroperative Parameters : Scope duration, perforation, hemorrhage, etc. complications) Postoperative parameters (stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc) Movement of kidney : Changes in renal stone position during simultaneous normal ventilation and single lung ventilation.

Group Type ACTIVE_COMPARATOR

Preoperative Parameters

Intervention Type DIAGNOSTIC_TEST

Preoperative Hmg and serum creatinine levels

Peroperative Parameters

Intervention Type OTHER

Scope duration, perforation, hemorrhage, etc. complications

Postoperative Parameters

Intervention Type OTHER

Stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc

Movement of kidney

Intervention Type OTHER

Changes in renal stone position during simultaneous normal ventilation and single lung ventilation.

single lung ventilation

Intervention Type PROCEDURE

Patients in this group will intubated with an endotracheal tube and then a bronchial blocker will be placed with the help of a fiberoptic bronchoscope or will be intubated with a double lumen endobronchial tube. One lung ventilation will be applied

Patients given standard ventilation

This group will have standard ventilation. Preoperative Parameters : Hmg, serum creatinine levels Peroperative Parameters : Scope duration, perforation, hemorrhage, etc. complications) Postoperative parameters (stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc) Movement of kidney : Changes in renal stone position during simultaneous normal ventilation and single lung ventilation.

Group Type ACTIVE_COMPARATOR

Preoperative Parameters

Intervention Type DIAGNOSTIC_TEST

Preoperative Hmg and serum creatinine levels

Peroperative Parameters

Intervention Type OTHER

Scope duration, perforation, hemorrhage, etc. complications

Postoperative Parameters

Intervention Type OTHER

Stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc

Movement of kidney

Intervention Type OTHER

Changes in renal stone position during simultaneous normal ventilation and single lung ventilation.

standard ventilation

Intervention Type PROCEDURE

Patients in this group will be intubated with standart single lumen endotracheal tubes and standart two lung ventilation will be applied.

Interventions

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Preoperative Parameters

Preoperative Hmg and serum creatinine levels

Intervention Type DIAGNOSTIC_TEST

Peroperative Parameters

Scope duration, perforation, hemorrhage, etc. complications

Intervention Type OTHER

Postoperative Parameters

Stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc

Intervention Type OTHER

Movement of kidney

Changes in renal stone position during simultaneous normal ventilation and single lung ventilation.

Intervention Type OTHER

single lung ventilation

Patients in this group will intubated with an endotracheal tube and then a bronchial blocker will be placed with the help of a fiberoptic bronchoscope or will be intubated with a double lumen endobronchial tube. One lung ventilation will be applied

Intervention Type PROCEDURE

standard ventilation

Patients in this group will be intubated with standart single lumen endotracheal tubes and standart two lung ventilation will be applied.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Older than 18 years
2. ASA (American Society of Anesthesiologists) 1-3
3. Patients with 2-3 cm stones in kidneys

Exclusion Criteria

1. Patients with staghorn stones in kidneys
2. Patients with urinary system anomalies

Removal Criteria :

1. Difficult airway
2. Patients with carinal, bronchial lesions
3. Patients with bad general situation
4. Patients younger than 18 years
5. Satiated patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role lead

Responsible Party

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Ömer Faruk Boran

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ömer Faruk Boran

Role: STUDY_CHAIR

Kahramanmaraş Üniversitesi

Locations

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Kahramanmaraş Sütçü Imam Üniversity

Kahramanmaraş, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ömer Faruk Boran

Role: CONTACT

+903442803400

Facility Contacts

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Ömer Faruk Boran

Role: primary

3442803796 ext. 3796

Other Identifiers

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17

Identifier Type: -

Identifier Source: org_study_id

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