Intracranial Pressure in Monopolar and Bipolar Hysteroscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Monopolar or Bipolar Hysteroscopy: Comparison of the Impact of Two Methods on Intracranial Pressure

Conditions
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Intracranial Pressure Increase

Intervention / Treatment
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* Procedure: Monopolar hysteroscopy
* Procedure: Bipolar hysteroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monopolar hysteroscopy<br>This group of patients will receive Monopolar hysteroscopy for uterine distention. | Procedure: Monopolar hysteroscopy<br>* Unipolar resectoscopes are used in this group and the distention fluid is mannitol<br>|
| Active Comparator: Bipolar hysteroscopy<br>This group of patients will receive Monopolar hysteroscopy for uterine distention. | Procedure: Bipolar hysteroscopy<br>* Bipolar resectoscopes are used in this group and the distention fluid is serum physiologic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracranial pressure | 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. | ONSD will be measured 3 times in the two groups. Before completion of hysteroscopy, 2 hours after hysteroscopy and 6 hours after hysteroscopy |