Kidney StoneNCT05431049
Anesthesia Type on Percutaneous Nephrolithotomy in Aging Male
An observational study of Kidney Stone and Anesthesia, run by Sedat Önen at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the anesthesia methods in percutaneous nephrolithotomy in terms of safety and effectiveness in elderly men. Read more about this study
- Who is it for?
- Ages 65 to 100 years, men only
- Conditions the study is for
- Kidney Stone, Anesthesia
- What is being tested?
- Percutaneous nephrolithotomy surgery (PNL)
- Type of treatment
- Surgery or procedure
- How many people
- 184 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 May 2021to 17 Nov 2021
- 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 65 to 100 years
- Men only
- No healthy volunteers
- Older adult
Study population: Above 65 years of age, male sex and having kidney stone
Who may be able to join
- Clinical diagnosis of Renal Stone Disease
- Above 65 years of age
- Male sex
Who cannot join
- Having low hemoglobin level before surgery
- Presence of hematology disease causing bleeding diathesis
- Presence of stones in an ectopic or transplanted kidney
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Anesthesia Type on the Outcomes of Percutaneous Nephrolithotomy in Aging Male
The aim of this study is to compare the anesthesia methods in percutaneous nephrolithotomy in terms of safety and effectiveness in elderly men.
Read the detailed description
Data recorded since 2003 will be analyzed retrospectively. Elderly men with PNL will be divided into two groups according to the type of anesthesia. The results determined in both arms will be compared with appropriate statistical methods.
- Conditions
- Kidney Stone, Anesthesia
- Being tested
- Percutaneous nephrolithotomy surgery (PNL)
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous nephrolithotomy surgery (PNL)Procedure or surgery
Also called spino-epidural anesthesia (CSEA), general anesthesia (GA)
Percutaneous nephrolithotomy (PNL) surgery was performed in all arms of the study to remove the renal stones. This surgery was performed with 2 anesthesia methods, CSEA and GA. These formed the groups of the study.
| Study group | Role | What they receive |
|---|---|---|
| combined spino-epidural anesthesia (CSEA) | Percutaneous nephrolithotomy under combined spino-epidural anesthesia Receives: Procedure: Percutaneous nephrolithotomy surgery (PNL) | |
| general anesthesia (GA) | Percutaneous nephrolithotomy under general anesthesia Receives: Procedure: Percutaneous nephrolithotomy surgery (PNL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rates
These are the success percentages depending on the outcome of the surgical procedure in both groups.
Measured: Post-surgery day 1
Complication rates
These are the complication percentages depending on the outcome of the surgical procedure in both groups.
Measured: During surgery to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start7 May 2021
- Primary completion30 Aug 2021
- Study completion17 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sedat Önen
- Sponsor type
- Other government
- Collaborators
- Bursa City Hospital
- Responsible party
- Sponsor-investigator, Sedat Önen, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431049
- Sponsor's protocol ID
- 2021-8/4
- Status last verified
- Jun 2022
- First submitted
- 12 Jun 2022
- Last updated
- 24 Jun 2022
- 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 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anesthesia Type on the Outcomes of Percutaneous Nephrolithotomy in Aging Male
- ClinicalTrials.gov ID
- NCT05431049
- Acronym / sponsor ID
- 2021-8/4
- Conditions
- Kidney Stone, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Sedat ÖnenOther government
- Collaborators
- Bursa City Hospital
- Study start
- 7 May 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 24 Jun 2022 (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.
The aim of this study is to compare the anesthesia methods in percutaneous nephrolithotomy in terms of safety and effectiveness in elderly men.
Detailed description
Data recorded since 2003 will be analyzed retrospectively. Elderly men with PNL will be divided into two groups according to the type of anesthesia. The results determined in both arms will be compared with appropriate statistical methods.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined spino-epidural anesthesia (CSEA) | – | Procedure: Percutaneous nephrolithotomy surgery (PNL)Percutaneous nephrolithotomy under combined spino-epidural anesthesia |
| general anesthesia (GA) | – | Procedure: Percutaneous nephrolithotomy surgery (PNL)Percutaneous nephrolithotomy under general anesthesia |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Above 65 years of age, male sex and having kidney stone
Key inclusion criteria (3 listed)
- Clinical diagnosis of Renal Stone Disease
- Above 65 years of age
- Male sex
Key exclusion criteria (3 listed)
- Having low hemoglobin level before surgery
- Presence of hematology disease causing bleeding diathesis
- Presence of stones in an ectopic or transplanted kidney
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 |
|---|---|---|
| Percutaneous nephrolithotomy surgery (PNL)Also: spino-epidural anesthesia (CSEA), general anesthesia (GA)Percutaneous nephrolithotomy (PNL) surgery was performed in all arms of the study to remove the renal stones. This surgery was performed with 2 anesthesia methods, CSEA and GA. These formed the groups of the study. | Procedure or surgery | combined spino-epidural anesthesia (CSEA), general anesthesia (GA) |
Primary outcome
Stone free rates
Time frame: Post-surgery day 1
These are the success percentages depending on the outcome of the surgical procedure in both groups.
Complication rates
Time frame: During surgery to 24 hours after surgery
These are the complication percentages depending on the outcome of the surgical procedure in both groups.
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 24 Jun 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Kidney Stone and Anesthesia, run by Sedat Önen 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 3 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 24 Jun 2022. 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?
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?
Stone free rates (time frame: Post-surgery day 1). The study lists 2 primary outcomes in all. 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 24 Jun 2022.