HoLEP (Holmium Laser Enucleation of Prostate)NCT07655830
Metabolic and Clinical Effects of Hyperchloremia During HoLEP Surgery.
An observational study of HoLEP (Holmium Laser Enucleation of Prostate) and Hyperchloremia, run by Ankara City Hospital Bilkent.
Trial summary
This study aims to evaluate the changes between preoperative and postoperative serum chloride levels in patients undergoing HoLEP surgery and to investigate the metabolic and clinical effects of this change. The study is observational, and no additional interventions will be performed. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HoLEP (Holmium Laser Enucleation of Prostate), Hyperchloremia, Perioperative Management
- What is being tested?
- HoLEP surgery
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 4 Jul 2026to 30 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for elective HoLEP surgery.
Who may be able to join
- Patients scheduled for elective HoLEP surgery.
- Patients providing written informed consent
Who cannot join
- Preoperative metabolic acidosis.
- Advanced renal failure.
- Emergency surgery.
- Missing data.
About this study
Official title: Evaluation of the Metabolic and Clinical Effects of Intraoperative Hyperchloremia in Holmium Laser Enucleation of Prostate (HoLEP) Surgery.
This study aims to evaluate the changes between preoperative and postoperative serum chloride levels in patients undergoing HoLEP surgery and to investigate the metabolic and clinical effects of this change. The study is observational, and no additional interventions will be performed.
Read the detailed description
Although isotonic irrigation fluids used in HoLEP surgery reduce the risk of hyponatremia associated with TUR syndrome, high-volume fluid absorption may lead to hyperchloremia and subsequent metabolic acidosis. This prospective, observational, single-center study, conducted at Ankara Bilkent City Hospital, aims to identify early markers of this condition to optimize perioperative management.
- 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 are part of routine clinical practice; no additional examinations are required
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing elective 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 serum chloride level
Measured: Perioperative
Secondary outcomes (2)
irrigation volume
Measured: Perioperative
Arter blood gas
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start4 Jul 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HoLEP (Holmium Laser Enucleation of Prostate)Studies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- 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
- NCT07655830
- Sponsor's protocol ID
- TABED1-26-2505
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 18 Jun 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Metabolic and Clinical Effects of Intraoperative Hyperchloremia in Holmium Laser Enucleation of Prostate (HoLEP) Surgery.
- ClinicalTrials.gov ID
- NCT07655830
- Acronym / sponsor ID
- TABED1-26-2505
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 4 Jul 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 18 Jun 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 the changes between preoperative and postoperative serum chloride levels in patients undergoing HoLEP surgery and to investigate the metabolic and clinical effects of this change. The study is observational, and no additional interventions will be performed.
Detailed description
Although isotonic irrigation fluids used in HoLEP surgery reduce the risk of hyponatremia associated with TUR syndrome, high-volume fluid absorption may lead to hyperchloremia and subsequent metabolic acidosis. This prospective, observational, single-center study, conducted at Ankara Bilkent City Hospital, aims to identify early markers of this condition to optimize perioperative management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing elective HoLEP surgery. | – | Procedure: HoLEP surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective HoLEP surgery.
Key inclusion criteria (2 listed)
- Patients scheduled for elective HoLEP surgery.
- Patients providing written informed consent
Key exclusion criteria (4 listed)
- Preoperative metabolic acidosis.
- Advanced renal failure.
- Emergency surgery.
- Missing data.
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 are part of routine clinical practice; no additional examinations are required | Procedure or surgery | Patients undergoing elective HoLEP surgery. |
Primary outcome
Change in serum chloride level
Time frame: Perioperative
2 secondary outcomes
irrigation volume
Time frame: Perioperative
Arter blood gas
Time frame: Perioperative
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 18 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HoLEP (Holmium Laser Enucleation of Prostate) and Hyperchloremia, run by Ankara City Hospital Bilkent.
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 2 inclusion and 4 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 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in serum chloride level (time frame: Perioperative). 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 18 Jun 2026.