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
• Status: Completed
• Phase: N/A
• 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
• 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,

Related Conditions & MeSH terms

• Hyperplasia
• Prostate Hyperplasia
• Prostatic Hyperplasia

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