Inflammatory Markers: HOLEP Versus TURP

NCT ID: NCT05108662

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Hyperplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HOLEP

Patients with a prostate volume greater than 80 g

Group Type ACTIVE_COMPARATOR

Surgery method

Intervention Type PROCEDURE

Patients were subdivided into two groups according to their prostate volume

TURP

Patients with a prostate volume less than 80 g

Group Type ACTIVE_COMPARATOR

Surgery method

Intervention Type PROCEDURE

Patients were subdivided into two groups according to their prostate volume

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surgery method

Patients were subdivided into two groups according to their prostate volume

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ASA scores I-III patients
* having benign prostatic hyperplasia
* undergoing HOLEP or TURP surgery under general anesthesia

Exclusion Criteria

* immune system disease,
* diabetes mellitus,
* malignancy other than prostate disease,
* history of steroid use,
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Adana City Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Baris Arslan, MD

Baris Arslan, MD, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Baris Arslan, MD

Role: PRINCIPAL_INVESTIGATOR

Adana City Training and Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Adana City Training and Research Hospital

Adana, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

49-708

Identifier Type: -

Identifier Source: org_study_id