NCT07607704

Brief Summary

This study aims to evaluate changes in driving pressure and static lung compliance during HoLEP surgery and to investigate their relationship with surgical and perioperative factors. This study is observational, and no changes will be made to the patients' current treatment processes.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
May 2026Aug 2026

Study Start

First participant enrolled

May 15, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 21, 2026

Last Update Submit

May 21, 2026

Conditions

Holmium Laser Enucleation of the ProstateLung Protective VentilationDriving Pressure

Outcome Measures

Primary Outcomes (2)

  • Change in intraoperative driving pressure

    Change in intraoperative driving pressure

    Measured at baseline after induction stabilization and every 30 minutes throughout the operation

  • Change in static lung compliance

    Change in static lung compliance

    Measured at baseline after induction stabilization and every 30 minutes throughout the operation

Study Arms (1)

Patients undergoing HoLEP surgery

Procedure: HoLEP surgery

Interventions

HoLEP surgeryPROCEDURE

All parameters used in the study are part of routine clinical practice. No additional intervention or examination will be performed

Patients undergoing HoLEP surgery

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for elective HoLEP surgery

You may qualify if:

  • Male patients over 18 years of age
  • Patients scheduled for elective HoLEP surgery
  • Patients who provide written informed consent

You may not qualify if:

  • Preoperative severe lung disease
  • Thoracic pathology that may affect mechanical ventilation
  • Conditions where spontaneous breathing cannot be suppressed
  • Missing data severe lung disease
  • Thoracic pathology that may affect mechanical ventilation
  • Conditions where spontaneous breathing cannot be suppressed
  • Missing data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Central Study Contacts

Betül Güven Aytaç, Assos prof

CONTACT

905073578351drbguven@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assos. Prof

Study Record Dates

First Submitted

May 21, 2026

First Posted

May 26, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

May 26, 2026

Record last verified: 2026-05

Locations

TU(1)