NCT05108662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
Last Updated

November 5, 2021

Status Verified

November 1, 2021

Enrollment Period

1.3 years

First QC Date

September 22, 2021

Last Update Submit

November 2, 2021

Conditions

Prostate Hyperplasia

Outcome Measures

Primary Outcomes (6)

  • inflamatory markers

    WBC (109 /L)

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

  • Stress hormone levels

    Adrenaline (ng/L)

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

  • inflamatory markers

    CRP

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

  • 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

  • inflamatory markers

    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

    Cortisol (microg/dl)

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

Study Arms (2)

HOLEP

ACTIVE COMPARATOR

Patients with a prostate volume greater than 80 g

Procedure: Surgery method

TURP

ACTIVE COMPARATOR

Patients with a prostate volume less than 80 g

Procedure: Surgery method

Interventions

Surgery methodPROCEDURE

Patients were subdivided into two groups according to their prostate volume

HOLEPTURP

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ASA scores I-III patients
  • having benign prostatic hyperplasia
  • undergoing HOLEP or TURP surgery under general anesthesia

You may not qualify if:

  • immune system disease,
  • diabetes mellitus,
  • malignancy other than prostate disease,
  • history of steroid use,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adana City Training and Research Hospital

Adana, 01170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Baris Arslan, MD

    Adana City Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Baris Arslan, MD, Principal investigator

Study Record Dates

First Submitted

September 22, 2021

First Posted

November 5, 2021

Study Start

February 1, 2020

Primary Completion

May 30, 2021

Study Completion

August 30, 2021

Last Updated

November 5, 2021

Record last verified: 2021-11

Locations

TU(1)