Inflammatory Markers: HOLEP Versus TURP

November 2, 2021 updated by: Baris Arslan, MD, Adana City Training and Research Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey, 01170
        • Adana City Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HOLEP
Patients with a prostate volume greater than 80 g
Procedure: Surgery method
Patients were subdivided into two groups according to their prostate volume
Active Comparator: TURP
Patients with a prostate volume less than 80 g
Procedure: Surgery method
Patients were subdivided into two groups according to their prostate volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflamatory markers
Time Frame: Change from baseline WBC (109 /L) at postoperative 0th and postoperative 24th hour
WBC (109 /L)
Change from baseline WBC (109 /L) at postoperative 0th and postoperative 24th hour
Stress hormone levels
Time Frame: Change from baseline adrenaline (ng/L) at postoperative 0th and postoperative 24th hour
Adrenaline (ng/L)
Change from baseline adrenaline (ng/L) at postoperative 0th and postoperative 24th hour
inflamatory markers
Time Frame: Change from baseline CRP (mg/L) at postoperative 0th and postoperative 24th hour
CRP
Change from baseline CRP (mg/L) at postoperative 0th and postoperative 24th hour
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)
Change from baseline IL-6 (pg/ml) and TNF-alfa (pg/ml), at postoperative 0th and postoperative 24th hour
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+
Change from baseline CD4+/CD8+ at postoperative 0th and postoperative 24th hourL-6 (pg/ml) and TNF-alfa (pg/ml)
stress hormone levels
Time Frame: Change from baseline cortisol (microg/dl) at postoperative 0th and postoperative 24th hour
Cortisol (microg/dl)
Change from baseline cortisol (microg/dl) at postoperative 0th and postoperative 24th hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adana City Training and Research Hospital

Investigators

  • Principal Investigator: Baris Arslan, MD, Adana City Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

May 30, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Actual)

November 5, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49-708

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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