Perioperative/Postoperative ComplicationsNCT03060837
Investigate the Renal Movement by Single Lung Ventilation in Patients Administered RIRS for Kidney Stones.
A study testing Preoperative Parameters, Peroperative Parameters and Postoperative Parameters in people with Perioperative/Postoperative Complications and Kidney Stone, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative/Postoperative Complications, Kidney Stone
- What is being tested?
- Preoperative Parameters, Peroperative Parameters and Postoperative Parameters
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2017to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years
- ASA (American Society of Anesthesiologists) 1-3
- Patients with 2-3 cm stones in kidneys
Who cannot join
- Patients with staghorn stones in kidneys
- Patients with urinary system anomalies
- Removal Criteria :
- Difficult airway
- Patients with carinal, bronchial lesions
- Patients with bad general situation
- Patients younger than 18 years
- Satiated patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kahramanmaraş Sütçü Imam Üniversity
Kahramanmaraş, 46000
Ömer Faruk Boran, 3442803796 ext. 3796, omerfarukboran@hotmail.com
About this study
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
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.
Read the detailed 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.
- Being tested
- Preoperative Parameters, Peroperative Parameters, Postoperative Parameters, Movement of kidney, single lung ventilation
- Keywords
- RIRS, Kidney Stone, Single lung ventilation, Simultaneous normal ventilation
- Medical subject headings
- Postoperative Complications, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative ParametersDiagnostic test
Preoperative Hmg and serum creatinine levels
Peroperative ParametersOther
Scope duration, perforation, hemorrhage, etc. complications
Postoperative ParametersOther
Stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc
Movement of kidneyOther
Changes in renal stone position during simultaneous normal ventilation and single lung ventilation.
single lung ventilationProcedure or surgery
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 ventilationProcedure or surgery
Patients in this group will be intubated with standart single lumen endotracheal tubes and standart two lung ventilation will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Patients given single lung ventilation | Active comparator | 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. Receives: Diagnostic Test: Preoperative Parameters; Other: Peroperative Parameters; Other: Postoperative Parameters; Other: Movement of kidney; Procedure: single lung ventilation |
| Patients given standard ventilation | Active comparator | 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. Receives: Diagnostic Test: Preoperative Parameters; Other: Peroperative Parameters; Other: Postoperative Parameters; Other: Movement of kidney; Procedure: standard ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2 Hours
Secondary outcomes (3)
Scope duration
Movement of the kidney during the procedure may cause peroperative complications and lengthen operation and scope durations.
Measured: 10-30 Seconds
Total anesthesia duration
Movement of the kidney during the procedure may cause peroperative complications and lengthen operation and scope durations.
Measured: 1-2 Hours
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.
Measured: 1-3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Mar 2017
- Primary completion20 Feb 2020
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative/Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Faruk Boran, Kahramanmaras Sutcu Imam University
- Investigators
- Ömer Faruk Boran, Study chair, Kahramanmaraş Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060837
- Sponsor's protocol ID
- 17
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03060837
- Acronym / sponsor ID
- 17
- Keywords
- RIRS, Kidney Stone, Single lung ventilation, Simultaneous normal ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients given single lung ventilation | Active comparator | Diagnostic Test: Preoperative Parameters, Other: Peroperative Parameters, Other: Postoperative Parameters, Other: Movement of kidney, Procedure: single lung ventilationThe 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. |
| Patients given standard ventilation | Active comparator | Diagnostic Test: Preoperative Parameters, Other: Peroperative Parameters, Other: Postoperative Parameters, Other: Movement of kidney, Procedure: standard ventilationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 18 years
- ASA (American Society of Anesthesiologists) 1-3
- Patients with 2-3 cm stones in kidneys
Key exclusion criteria (8 listed)
- Patients with staghorn stones in kidneys
- Patients with urinary system anomalies
- Difficult airway
- Patients with carinal, bronchial lesions
- Patients with bad general situation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative ParametersPreoperative Hmg and serum creatinine levels | Diagnostic test | Patients given single lung ventilation, Patients given standard ventilation |
| Peroperative ParametersScope duration, perforation, hemorrhage, etc. complications | Other | Patients given single lung ventilation, Patients given standard ventilation |
| Postoperative ParametersStone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc | Other | Patients given single lung ventilation, Patients given standard ventilation |
| Movement of kidneyChanges in renal stone position during simultaneous normal ventilation and single lung ventilation. | Other | Patients given single lung ventilation, Patients given standard ventilation |
| single lung ventilationPatients 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 | Procedure or surgery | Patients given single lung ventilation |
| standard ventilationPatients in this group will be intubated with standart single lumen endotracheal tubes and standart two lung ventilation will be applied. | Procedure or surgery | Patients given standard ventilation |
Primary outcome
Changes in renal stone position during ventilation
Time frame: 1-2 Hours
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.
3 secondary outcomes
Scope duration
Time frame: 10-30 Seconds
Total anesthesia duration
Time frame: 1-2 Hours
Hospital stay
Time frame: 1-3 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ömer Faruk Boran study chair
Kahramanmaraş Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Parameters, Peroperative Parameters and Postoperative Parameters in people with Perioperative/Postoperative Complications and Kidney Stone, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ömer Faruk Boran (+903442803400, omerfarukboran@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in renal stone position during ventilation (time frame: 1-2 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.