Prostate HyperplasiaNCT05108662
Inflammatory Markers: HOLEP Versus TURP
A study testing Surgery method in people with Prostate Hyperplasia, run by Adana City Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aim of the study is to compare the systemic inflammatory markers and surgical stress response in patients undergoing HOLEP or TUR-P surgery. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Hyperplasia
- What is being tested?
- Surgery method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 30 Aug 2021
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ASA scores I-III patients
- having benign prostatic hyperplasia
- undergoing HOLEP or TURP surgery under general anesthesia
Who cannot join
- immune system disease,
- diabetes mellitus,
- malignancy other than prostate disease,
- history of steroid use,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adana City Training and Research Hospital
Adana, 01170
About this study
Official title: Comparison of Surgical Stress in Patients Undergoing TURP Versus HOLEP Surgery by Measuring Perioperative Systemic Inflammatory Markers
Aim of the study is to compare the systemic inflammatory markers and surgical stress response in patients undergoing HOLEP or TUR-P surgery.
Read the detailed description
Benign prostatic hyperplasia (BPH) is the most common disease in aging men worldwide, causing significant difficulties and resulting in bladder outlet obstruction. Basically, surgical techniques in patients with BPH are transurethral resection of the prostate (TURP), holmium laser enucleation of the prostate (HOLEP), and open prostoactemy surgery. There are many studies comparing the clinical outcomes of TURP and HOLEP surgery. However, to the best of our knowledge, there has not been a study comparing the effects of these two types of surgery on inflammatory markers and stress hormones.
- Conditions
- Prostate Hyperplasia
- Being tested
- Surgery method
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery methodProcedure or surgery
Patients were subdivided into two groups according to their prostate volume
| Study group | Role | What they receive |
|---|---|---|
| HOLEP | Active comparator | Patients with a prostate volume greater than 80 g Receives: Procedure: Surgery method |
| TURP | Active comparator | Patients with a prostate volume less than 80 g Receives: Procedure: Surgery method |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflamatory markers
WBC (109 /L)
Measured: Change from baseline WBC (109 /L) at postoperative 0th and postoperative 24th hour
Stress hormone levels
Adrenaline (ng/L)
Measured: Change from baseline adrenaline (ng/L) at postoperative 0th and postoperative 24th hour
inflamatory markers
CRP
Measured: Change from baseline CRP (mg/L) at postoperative 0th and postoperative 24th hour
inflamatory markers
IL-6 (pg/ml) and TNF-alfa (pg/ml)
Measured: Change from baseline IL-6 (pg/ml) and TNF-alfa (pg/ml), at postoperative 0th and postoperative 24th hour
inflamatory markers
CD4+/CD8+
Measured: Change from baseline CD4+/CD8+ at postoperative 0th and postoperative 24th hourL-6 (pg/ml) and TNF-alfa (pg/ml)
stress hormone levels
Cortisol (microg/dl)
Measured: Change from baseline cortisol (microg/dl) at postoperative 0th and postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Feb 2020
- Primary completion30 May 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate HyperplasiaStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adana City Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baris Arslan, MD, Adana City Training and Research Hospital
- Investigators
- Baris Arslan, MD, Principal investigator, Adana City Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108662
- Sponsor's protocol ID
- 49-708
- Status last verified
- Nov 2021
- First submitted
- 22 Sep 2021
- Last updated
- 5 Nov 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 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Stress in Patients Undergoing TURP Versus HOLEP Surgery by Measuring Perioperative Systemic Inflammatory Markers
- ClinicalTrials.gov ID
- NCT05108662
- Acronym / sponsor ID
- 49-708
- Conditions
- Prostate Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Adana City Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 5 Nov 2021 (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.
Aim of the study is to compare the systemic inflammatory markers and surgical stress response in patients undergoing HOLEP or TUR-P surgery.
Detailed description
Benign prostatic hyperplasia (BPH) is the most common disease in aging men worldwide, causing significant difficulties and resulting in bladder outlet obstruction. Basically, surgical techniques in patients with BPH are transurethral resection of the prostate (TURP), holmium laser enucleation of the prostate (HOLEP), and open prostoactemy surgery. There are many studies comparing the clinical outcomes of TURP and HOLEP surgery. However, to the best of our knowledge, there has not been a study comparing the effects of these two types of surgery on inflammatory markers and stress hormones.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOLEP | Active comparator | Procedure: Surgery methodPatients with a prostate volume greater than 80 g |
| TURP | Active comparator | Procedure: Surgery methodPatients with a prostate volume less than 80 g |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ASA scores I-III patients
- having benign prostatic hyperplasia
- undergoing HOLEP or TURP surgery under general anesthesia
Key exclusion criteria (4 listed)
- immune system disease,
- diabetes mellitus,
- malignancy other than prostate disease,
- history of steroid use,
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 |
|---|---|---|
| Surgery methodPatients were subdivided into two groups according to their prostate volume | Procedure or surgery | HOLEP, TURP |
Primary outcome
inflamatory markers
Time frame: Change from baseline WBC (109 /L) at postoperative 0th and postoperative 24th hour
WBC (109 /L)
Stress hormone levels
Time frame: Change from baseline adrenaline (ng/L) at postoperative 0th and postoperative 24th hour
Adrenaline (ng/L)
inflamatory markers
Time frame: Change from baseline CRP (mg/L) at postoperative 0th and postoperative 24th hour
CRP
inflamatory markers
Time frame: Change from baseline IL-6 (pg/ml) and TNF-alfa (pg/ml), at postoperative 0th and postoperative 24th hour
IL-6 (pg/ml) and TNF-alfa (pg/ml)
inflamatory markers
Time frame: Change from baseline CD4+/CD8+ at postoperative 0th and postoperative 24th hourL-6 (pg/ml) and TNF-alfa (pg/ml)
CD4+/CD8+
stress hormone levels
Time frame: Change from baseline cortisol (microg/dl) at postoperative 0th and postoperative 24th hour
Cortisol (microg/dl)
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 5 Nov 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.
Baris Arslan, MD principal investigator
Adana City Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery method in people with Prostate Hyperplasia, run by Adana City Training and Research Hospital 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 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: finished, as of the sponsor's last update on 5 Nov 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 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?
inflamatory markers (time frame: Change from baseline WBC (109 /L) at postoperative 0th and postoperative 24th hour). The study lists 6 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 5 Nov 2021.