Renal StoneNCT03373617
The Effect of Anesthesia Type on RIRS
An observational study of Renal Stone, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Retrograde intrarenal surgery (RIRS) with flexible ureteroscopy is based on video monitoring of urinary tract during operation. Therefore, shaking vision on monitor can bother surgeons and make them tired. This can lead in tissue injury from lasing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stone
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Dec 2017to 14 Jan 2019
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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
Study population: Patients requiring RIRS because of renal stone
Who may be able to join
- Patients requiring RIRS because of renal stone.
Who cannot join
- disagreement for the trial.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 07061
About this study
Official title: The Effect of Anesthesia Type on the Surgical Field in Retrograde Intrarenal Surgery With Flexible Ureteroscopy in Renal Stone Patients
Retrograde intrarenal surgery (RIRS) with flexible ureteroscopy is based on video monitoring of urinary tract during operation. Therefore, shaking vision on monitor can bother surgeons and make them tired. This can lead in tissue injury from lasing.
The purpose of this study is to investigate the stability of monitoring of surgical field which is assessed by surgeon.
Read the detailed description
RIRS with flexible ureteroscopy is usually performed under general anesthesia, spinal anesthesia.
Anesthesia type is decided in the basis of medical condition of a patient and patient's preference.
This study is a prospective observational study. During operation after induction of anesthesia, surgeons will be asked how visual stability of surgical field on monitor is (scale from 0 to 10).
According to anesthesia type (general anesthesia, spinal anesthesia), 34 patients will be enrolled and investigated in each group.
Investigators will compare the scale for visual stability of surgical field during RIRS.
- Conditions
- Renal Stone
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia group | Patients in general anesthesia group are scheduled to undergo RIRS under general anesthesia. | |
| Spinal anesthesia group | Patients in spinal anesthesia group are scheduled to undergo RIRS under spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS for stability of monitoring
VAS (from 1 to 10) for stability in monitoring of surgical field, which is assessed by surgeons
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start13 Dec 2017
- Primary completion28 Dec 2018
- Study completion14 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StoneStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Jung-Man Lee, Seoul National University Hospital
- Investigators
- Jung-Man Lee, M.D.,PhD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373617
- Sponsor's protocol ID
- 20-2017-10
- Status last verified
- Jul 2021
- First submitted
- 11 Dec 2017
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anesthesia Type on the Surgical Field in Retrograde Intrarenal Surgery With Flexible Ureteroscopy in Renal Stone Patients
- ClinicalTrials.gov ID
- NCT03373617
- Acronym / sponsor ID
- 20-2017-10
- Conditions
- Renal Stone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 14 Dec 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.
Retrograde intrarenal surgery (RIRS) with flexible ureteroscopy is based on video monitoring of urinary tract during operation. Therefore, shaking vision on monitor can bother surgeons and make them tired. This can lead in tissue injury from lasing.
The purpose of this study is to investigate the stability of monitoring of surgical field which is assessed by surgeon.
Detailed description
RIRS with flexible ureteroscopy is usually performed under general anesthesia, spinal anesthesia.
Anesthesia type is decided in the basis of medical condition of a patient and patient's preference.
This study is a prospective observational study. During operation after induction of anesthesia, surgeons will be asked how visual stability of surgical field on monitor is (scale from 0 to 10).
According to anesthesia type (general anesthesia, spinal anesthesia), 34 patients will be enrolled and investigated in each group.
Investigators will compare the scale for visual stability of surgical field during RIRS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia group | – | –Patients in general anesthesia group are scheduled to undergo RIRS under general anesthesia. |
| Spinal anesthesia group | – | –Patients in spinal anesthesia group are scheduled to undergo RIRS under spinal anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring RIRS because of renal stone
Key inclusion criteria (1 listed)
- Patients requiring RIRS because of renal stone.
Key exclusion criteria (1 listed)
- disagreement for the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VAS for stability of monitoring
Time frame: intraoperative
VAS (from 1 to 10) for stability in monitoring of surgical field, which is assessed by surgeons
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
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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.
Jung-Man Lee, M.D.,PhD principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Stone, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jul 2021. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS for stability of monitoring (time frame: intraoperative). 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 23 Jul 2021.