Intracranial Pressure in Monopolar and Bipolar Hysteroscopy

Not Applicable

Completed

• Conditions: Intracranial Pressure Increase
• Interventions: Procedure: Monopolar hysteroscopy; Procedure: Bipolar hysteroscopy

• Registration Number: NCT04004923
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-06-30
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-02
• Study Start: 2019-07-05
• Primary Completion: 2019-10-25
• Study Completion: 2019-10-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monopolar hysteroscopy	Monopolar hysteroscopy	This group of patients will receive Monopolar hysteroscopy for uterine distention.
Bipolar hysteroscopy	Bipolar hysteroscopy	This group of patients will receive Monopolar hysteroscopy for uterine distention.

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Kanuni Sultan Suleyman Training and Research Hospital; 🇹🇷 Istanbul, Please Enter The State Or Province, Turkey