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Inflammatory Markers: HOLEP Versus TURP

Primary Purpose

Prostate Hyperplasia

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Surgery method

About this trial

This is an interventional other trial for Prostate Hyperplasia

Eligibility Criteria

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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,

Sites / Locations

Adana City Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

HOLEP

TURP

Arm Description

Patients with a prostate volume greater than 80 g

Patients with a prostate volume less than 80 g

Outcomes

Primary Outcome Measures

inflamatory markers

WBC (109 /L)

Stress hormone levels

Adrenaline (ng/L)

inflamatory markers

CRP

inflamatory markers

IL-6 (pg/ml) and TNF-alfa (pg/ml)

inflamatory markers

CD4+/CD8+

stress hormone levels

Cortisol (microg/dl)

Secondary Outcome Measures

Full Information

NCT ID

NCT05108662

First Posted

September 22, 2021

Last Updated

November 2, 2021

Sponsor

Adana City Training and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05108662

Brief Title

Inflammatory Markers: HOLEP Versus TURP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

February 1, 2020 (Actual)

Primary Completion Date

May 30, 2021 (Actual)

Study Completion Date

August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Adana City Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Hyperplasia

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HOLEP

Arm Type

Active Comparator

Arm Description

Patients with a prostate volume greater than 80 g

Arm Title

TURP

Arm Type

Active Comparator

Arm Description

Patients with a prostate volume less than 80 g

Intervention Type

Procedure

Intervention Name(s)

Surgery method

Intervention Description

Patients were subdivided into two groups according to their prostate volume

Primary Outcome Measure Information:

Title

inflamatory markers

Description

WBC (109 /L)

Time Frame

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

Title

Stress hormone levels

Description

Adrenaline (ng/L)

Time Frame

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

Title

inflamatory markers

Description

CRP

Time Frame

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

Title

inflamatory markers

Description

IL-6 (pg/ml) and TNF-alfa (pg/ml)

Time Frame

Change from baseline IL-6 (pg/ml) and TNF-alfa (pg/ml), at postoperative 0th and postoperative 24th hour

Title

inflamatory markers

Description

CD4+/CD8+

Time Frame

Change from baseline CD4+/CD8+ at postoperative 0th and postoperative 24th hourL-6 (pg/ml) and TNF-alfa (pg/ml)

Title

stress hormone levels

Description

Cortisol (microg/dl)

Time Frame

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

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

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,

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Baris Arslan, MD

Organizational Affiliation

Adana City Training and Research Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Adana City Training and Research Hospital

City

Adana

ZIP/Postal Code

01170

Country

Turkey

12. IPD Sharing Statement

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Inflammatory Markers: HOLEP Versus TURP

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