Holmium Laser Enucleation of the ProstateNCT07607704
Intraoperative Lung Mechanics Changes During HoLEP Surgery
An observational study of Holmium Laser Enucleation of the Prostate and Lung Protective Ventilation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate changes in driving pressure and static lung compliance during HoLEP surgery and to investigate their relationship with surgical and perioperative factors. This study is observational, and no changes will be made to the patients' current treatment processes. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Holmium Laser Enucleation of the Prostate, Lung Protective Ventilation, Driving Pressure
- What is being tested?
- HoLEP surgery
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective HoLEP surgery
Who may be able to join
- Male patients over 18 years of age
- Patients scheduled for elective HoLEP surgery
- Patients who provide written informed consent
Who cannot join
- Preoperative severe lung disease
- Thoracic pathology that may affect mechanical ventilation
- Conditions where spontaneous breathing cannot be suppressed
- Missing data severe lung disease
- Thoracic pathology that may affect mechanical ventilation
- Conditions where spontaneous breathing cannot be suppressed
- Missing data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara
Betül Güven Aytaç, Assos prof, 905073578351, drbguven@hotmail.com
About this study
Official title: Evaluation of Intraoperative Driving Pressure and Static Lung Compliance Changes in Holmium Laser Enucleation of Prostate (HoLEP) Surgery
This study aims to evaluate changes in driving pressure and static lung compliance during HoLEP surgery and to investigate their relationship with surgical and perioperative factors. This study is observational, and no changes will be made to the patients' current treatment processes.
- Being tested
- HoLEP surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoLEP surgeryProcedure or surgery
All parameters used in the study are part of routine clinical practice. No additional intervention or examination will be performed
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing HoLEP surgery | Not described Receives: Procedure: HoLEP surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intraoperative driving pressure
Change in intraoperative driving pressure
Measured: Measured at baseline after induction stabilization and every 30 minutes throughout the operation
Change in static lung compliance
Change in static lung compliance
Measured: Measured at baseline after induction stabilization and every 30 minutes throughout the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start15 May 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Holmium Laser Enucleation of the ProstateStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Güven, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607704
- Sponsor's protocol ID
- TABED1-26-2596
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative Driving Pressure and Static Lung Compliance Changes in Holmium Laser Enucleation of Prostate (HoLEP) Surgery
- ClinicalTrials.gov ID
- NCT07607704
- Acronym / sponsor ID
- TABED1-26-2596
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 26 May 2026 (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.
This study aims to evaluate changes in driving pressure and static lung compliance during HoLEP surgery and to investigate their relationship with surgical and perioperative factors. This study is observational, and no changes will be made to the patients' current treatment processes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing HoLEP surgery | – | Procedure: HoLEP surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective HoLEP surgery
Key inclusion criteria (3 listed)
- Male patients over 18 years of age
- Patients scheduled for elective HoLEP surgery
- Patients who provide written informed consent
Key exclusion criteria (7 listed)
- Preoperative severe lung disease
- Thoracic pathology that may affect mechanical ventilation
- Conditions where spontaneous breathing cannot be suppressed
- Missing data severe lung disease
- Thoracic pathology that may affect mechanical ventilation
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 |
|---|---|---|
| HoLEP surgeryAll parameters used in the study are part of routine clinical practice. No additional intervention or examination will be performed | Procedure or surgery | Patients undergoing HoLEP surgery |
Primary outcome
Change in intraoperative driving pressure
Time frame: Measured at baseline after induction stabilization and every 30 minutes throughout the operation
Change in intraoperative driving pressure
Change in static lung compliance
Time frame: Measured at baseline after induction stabilization and every 30 minutes throughout the operation
Change in static lung compliance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Holmium Laser Enucleation of the Prostate and Lung Protective Ventilation, run by Ankara City Hospital Bilkent 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 7 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: opening soon, as of the sponsor's last update on 26 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betül Güven Aytaç, Assos prof (905073578351, drbguven@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intraoperative driving pressure (time frame: Measured at baseline after induction stabilization and every 30 minutes throughout the operation). 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 26 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.