Inflammatory Markers: HOLEP Versus TURP

Not Applicable

Completed

• Conditions: Prostate Hyperplasia
• Interventions: Procedure: Surgery method

• Registration Number: NCT05108662
• Lead Sponsor: Adana City Training and Research Hospital

Brief Summary

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 Timeline

• Study Start: 2020-02-01
• Primary Completion: 2021-05-30
• Study Completion: 2021-08-30
• Study First Submitted: 2021-09-22
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-02
• Last Update Submitted: 2021-11-02
• Study First Posted: 2021-11-05
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TURP	Surgery method	Patients with a prostate volume less than 80 g
HOLEP	Surgery method	Patients with a prostate volume greater than 80 g

Primary Outcome Measures

Name	Time	Method
inflamatory markers	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	Change from baseline adrenaline (ng/L) at postoperative 0th and postoperative 24th hour	Adrenaline (ng/L)
stress hormone levels	Change from baseline cortisol (microg/dl) at postoperative 0th and postoperative 24th hour	Cortisol (microg/dl)

Trial Locations

Locations (1)

Adana City Training and Research Hospital; 🇹🇷 Adana, Turkey