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Difficult Intubation in HoLEP Surgery

StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Minor Completed without a posted recruiting period Show 4 more changesShow less
    • Final enrollment: 700 participants (planned 300)
    • Primary completion date changed from estimate of Aug 31, 2026 to Jul 31, 2026
    • Study completion date changed from estimate of Dec 31, 2026 to Sep 15, 2026
    • Eligibility criteria expanded, about 1 word
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07688954
Lead Sponsor Ankara City Hospital Bilkent
Conditions
(from sponsor)
Difficult Intubation, Holmium Laser Enucleation of the Prostate
Enrollment 700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov