Intracranial Pressure in Monopolar and Bipolar Hysteroscopy

NCT ID: NCT04004923

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-05

Study Completion Date

2019-10-30

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.

Conditions

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Intracranial Pressure Increase

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Monopolar hysteroscopy

This group of patients will receive Monopolar hysteroscopy for uterine distention.

Group Type ACTIVE_COMPARATOR

Monopolar hysteroscopy

Intervention Type PROCEDURE

Unipolar resectoscopes are used in this group and the distention fluid is mannitol

Bipolar hysteroscopy

This group of patients will receive Monopolar hysteroscopy for uterine distention.

Group Type ACTIVE_COMPARATOR

Bipolar hysteroscopy

Intervention Type PROCEDURE

Bipolar resectoscopes are used in this group and the distention fluid is serum physiologic

Interventions

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Monopolar hysteroscopy

Unipolar resectoscopes are used in this group and the distention fluid is mannitol

Intervention Type PROCEDURE

Bipolar hysteroscopy

Bipolar resectoscopes are used in this group and the distention fluid is serum physiologic

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Huseyin Kiyak

Principal Investigator, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huseyin Kiyak, MD

Role: PRINCIPAL_INVESTIGATOR

Kanuni Sultan Suleyman Hospital

Locations

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Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Please Enter the State Or Province, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Huseyin4

Identifier Type: -

Identifier Source: org_study_id

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