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

Perioperative/Postoperative Complications Clinical Trial

Official title:

To Investigate the Effect of Reducing Renal Movement by Single Lung Ventilation in Patients Administered Retrograde Infrarenal Surgery (RIRS) for Kidney Stones on Operative and Postoperative Parameters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03060837
• Other study ID #: 17
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: February 2020
• Source: Kahramanmaras Sutcu Imam University
• Contact: Ömer Faruk Boran
• Phone: +903442803400
• Email: omerfarukboran[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 1, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Diagnostic Test:
• Preoperative Parameters
Preoperative Hmg and serum creatinine levels

Other:
• 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.

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

Locations

Country	Name	City	State
Turkey	Kahramanmaras Sütçü Imam Üniversity	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perop-postop complications	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.	1-2 Days
Primary	Changes in renal stone position during ventilation	During the operation, the stone may move during deep inspirium and expirium sequences linked to deep ventilation which may lengthen the operation. Preoperative and postoperative Scope will be used to evolve the renal movement. The values will be recorded in milimeters by comparing it.	1-2 Hours
Secondary	Scope duration	Movement of the kidney during the procedure may cause peroperative complications and lengthen operation and scope durations.	10-30 Seconds
Secondary	Total anesthesia duration	Movement of the kidney during the procedure may cause peroperative complications and lengthen operation and scope durations.	1-2 Hours
Secondary	Hospital stay	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. It may effect hospital stay duration.	1-3 Days