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Completed

NCT Number: NCT05108662

Inflammatory Markers: HOLEP Versus TURP

Aim of the study is to compare the systemic inflammatory markers and surgical stress response in patients undergoing HOLEP or TUR-P surgery.

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Key information

Conditions

Prostate Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Adana City Training and Research Hospital

Adana, 01170, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Surgery method

Procedure

Patients were subdivided into two groups according to their prostate volume

Primary outcomes

  1. inflamatory markers

    Time frame: Change from baseline WBC (109 /L) at postoperative 0th and postoperative 24th hour

    WBC (109 /L)

  2. Stress hormone levels

    Time frame: Change from baseline adrenaline (ng/L) at postoperative 0th and postoperative 24th hour

    Adrenaline (ng/L)

  3. inflamatory markers

    Time frame: Change from baseline CRP (mg/L) at postoperative 0th and postoperative 24th hour

    CRP

  4. 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)

  5. 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+

  6. stress hormone levels

    Time frame: Change from baseline cortisol (microg/dl) at postoperative 0th and postoperative 24th hour

    Cortisol (microg/dl)

Sponsors and collaborators

Lead sponsor

Adana City Training and Research Hospital

Other

Registry information

Official study title

Comparison of Surgical Stress in Patients Undergoing TURP Versus HOLEP Surgery by Measuring Perioperative Systemic Inflammatory Markers

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2021
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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