Intracranial Pressure in Monopolar and Bipolar Hysteroscopy

Overview

Two distinction fluids are used in operative hysteroscopy. One is monopolar and the second is bipolar. The monopolar fluid contains mannitol and the bipolar fluid contains serum physiologic. This study aims to compare intracranial pressure in patients undergoing monopolar and bipolar hysteroscopy.

Full Title of Study: “Monopolar or Bipolar Hysteroscopy: Comparison of the Impact of Two Methods on Intracranial Pressure”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: October 25, 2019

Detailed Description

Operative hysteroscopy is currently used in the treatment of several diseases including submucosal myomas, polyps, uterine septum, and abnormal intrauterine bleeding. Two different methods for distension of the uterus for hysteroscopy are available currently. One is monopolar and the second is bipolar. The monopolar fluid contains mannitol and the bipolar fluid contains serum physiologic. Passage of the distention fluid into the uterine veins during hysteroscopy might lead to volume overload, water intoxication, hyponatremia, pulmonary edema or brain edema. However, the effect of monopolar hysteroscopy or bipolar hysteroscopy on intracranial pressure in patients undergoing hysteroscopy is unknown. Optic nerve sheath diameter (ONSD) measurement is a surrogate marker of invasive intracranial pressure. This study aims to compare the impact of monopolar and bipolar hysteroscopy on intracranial pressure by using ONSD measurement in patients undergoing hysteroscopy.

Interventions

  • Procedure: Monopolar hysteroscopy
    • Unipolar resectoscopes are used in this group and the distention fluid is mannitol
  • Procedure: Bipolar hysteroscopy
    • Bipolar resectoscopes are used in this group and the distention fluid is serum physiologic

Arms, Groups and Cohorts

  • Active Comparator: Monopolar hysteroscopy
    • This group of patients will receive Monopolar hysteroscopy for uterine distention.
  • Active Comparator: Bipolar hysteroscopy
    • This group of patients will receive Monopolar hysteroscopy for uterine distention.

Clinical Trial Outcome Measures

Primary Measures

  • Intracranial pressure
    • Time Frame: ONSD will be measured 3 times in the two groups. Before completion of hysteroscopy, 2 hours after hysteroscopy and 6 hours after hysteroscopy
    • The difference in intracranial pressure between the two study arms measured with optic nerve sheath diameter (ONSD). ONSD is measured using a linear ultrasound probe and reflects intracranial pressure.

Participating in This Clinical Trial

Inclusion Criteria

  • Must be scheduled to hysteroscopy for treatment of uterine myoma, polyp, septum, or for endometrial ablation. Exclusion Criteria:

  • Postmenopause; – Kidney disease; – Cardiovascular disease; – Glaucoma

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kanuni Sultan Suleyman Training and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Huseyin Kiyak, Principal Investigator, M.D. – Kanuni Sultan Suleyman Training and Research Hospital
  • Overall Official(s)
    • Huseyin Kiyak, MD, Principal Investigator, Kanuni Sultan Suleyman Hospital

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