Clinical Trials Logo
  1. Home
  2. Prostate Hyperplasia
  3. NCT05108662
  4. Details
NCT05108662 Clinical Trial

Inflammatory Markers: HOLEP Versus TURP

Prostate Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05108662
Other study ID # 49-708
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date August 30, 2021

Study information
Verified date November 2021
Source Adana City Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date August 30, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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,

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Surgery method
Patients were subdivided into two groups according to their prostate volume

Locations
Country Name City State
Turkey Adana City Training and Research Hospital Adana

Sponsors (1)
Lead Sponsor Collaborator
Adana City Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary inflamatory markers WBC (109 /L) Change from baseline WBC (109 /L) at postoperative 0th and postoperative 24th hour
Primary Stress hormone levels Adrenaline (ng/L) Change from baseline adrenaline (ng/L) at postoperative 0th and postoperative 24th hour
Primary inflamatory markers CRP Change from baseline CRP (mg/L) at postoperative 0th and postoperative 24th hour
Primary inflamatory markers IL-6 (pg/ml) and TNF-alfa (pg/ml) Change from baseline IL-6 (pg/ml) and TNF-alfa (pg/ml), at postoperative 0th and postoperative 24th hour
Primary inflamatory markers CD4+/CD8+ Change from baseline CD4+/CD8+ at postoperative 0th and postoperative 24th hourL-6 (pg/ml) and TNF-alfa (pg/ml)
Primary stress hormone levels Cortisol (microg/dl) Change from baseline cortisol (microg/dl) at postoperative 0th and postoperative 24th hour
See also
  Status Clinical Trial Phase
Recruiting NCT05443451 - BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY N/A
Recruiting NCT04288427 - 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy N/A
Not yet recruiting NCT05017285 - Ejaculation Preservation After Laser Enucleation Prostate N/A
Completed NCT02778243 - Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level N/A
Completed NCT04212403 - Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB) N/A
Recruiting NCT05440981 - Implanted Nitinol Device (iTind) System in Chinese Males With Lower Urinary Tract Symptom Secondary to BPH N/A
Recruiting NCT05531240 - Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE) N/A
Recruiting NCT03176017 - Ejaculatory Sparing Transurethral Incision Of The Prostate (ES-TUIP) Versus Conventional TUIP N/A
Completed NCT02244294 - FLOMAX® Versus Placebo, in Male Patients With Acute Urinary Retention Related to Benign Prostatic Hyperplasia (BPH) Phase 2
Recruiting NCT03966950 - Use of Melatonin for Preventing POCD in Transurethral Prostate Resection Under Spinal Anesthesia N/A
Recruiting NCT06116851 - Prostate Metabolism, Cancer Risk and Gut Microbiota
Completed NCT04781985 - Prostatic Resection Cavity Stone Post Transurethral Resection of the Prostate (TURP). A Rare Case Scenario N/A
Not yet recruiting NCT01876836 - Clasic Laryngeal Mask Airway(C-LMA) and I-gel Releated Regurgitation and Complications Phase 4
Not yet recruiting NCT05941260 - Standardization of Prostatic Resection by Virtual Computational Reconstruction and Computational Flow Dynamics
Completed NCT04580628 - Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)
Completed NCT04848181 - The Effect of Pre-operative Use of Finasteride Versus Cyproterone Acetate on Blood Loss With Transurethral Resection of Prostate Early Phase 1
Not yet recruiting NCT06224218 - Prostate Single Port & Laser Enucleation Comparison Trial N/A
Completed NCT04781049 - Transperineal Laser Ablation vs Transurethral Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial N/A
Completed NCT05059431 - The Effect of Human Prostate Tissue on Platelet Activation
Completed NCT04275076 - HoLEP Vs BPEP for Large Prostatic Adenoma Phase 3