Difficult Intubation in HoLEP Surgery

June 30, 2026 updated by: Betül Güven, Ankara City Hospital Bilkent

Retrospective Evaluation of Difficult Intubation Incidence and Associated Risk Factors in Holmium Laser Enucleation of the Prostate (HoLEP) Surgery

The goal of this observational study is to determine the incidence of difficult intubation and evaluate the associated clinical risk factors in patients undergoing Holmium Laser Enucleation of the Prostate (HoLEP) surgery under general anesthesia. The main questions it aims to answer are:

What is the incidence of difficult intubation among patients undergoing HoLEP surgery? Are clinical parameters such as increased BMI, alpha-blocker use, high prostate volume, high ASA score, and high Mallampati class independent risk factors for difficult intubation in this specific patient population?

Participants' data will be evaluated retrospectively, and the study involves the following tasks based on medical records:

Reviewing preoperative demographic and clinical data including age, BMI, ASA score, comorbid diseases, alpha-blocker use, smoking history, and Mallampati class.

Extracting intraoperative airway management data such as Cormack-Lehane score, number of intubation attempts, and the use of alternative devices like videolaryngoscopes or gum elastic bougies.

Analyzing surgical parameters including prostate volume and total operation duration to identify their relationship with intubation outcomes.

Study Overview

Study Type

Observational

Enrollment (Estimated)

300

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent elective HoLEP surgery under general anesthesia

Description

Inclusion Criteria:

  • Patients aged over 18 years Underwent elective HoLEP (Holmium Laser Enucleation of the Prostate) surgery Received general anesthesia

Exclusion Criteria:

Emergency surgery Missing or incomplete anesthesia records Pre-existing known advanced airway anomalies History of tracheostomy

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

Cohorts and Interventions

Group / Cohort
HoLEP Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Difficult Intubation
Time Frame: Intraoperative period
Percentage of patients who experienced difficult intubation (defined by Cormack-Lehane score, number of intubation attempts, or use of alternative airway devices like videolaryngoscope/buji).
Intraoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk Factors for Difficult Intubation
Time Frame: Preoperative and intraoperative periods
Association of clinical and demographic parameters (including BMI, alpha-blocker use, prostate volume, ASA score, and Mallampati class) with the occurrence of difficult intubation
Preoperative and intraoperative periods

Collaborators and Investigators

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

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 (Estimated)

July 5, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • TABED1-26-2748

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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