Back to resultsIntracranial Pressure in Monopolar and Bipolar Hysteroscopy
Primary Purpose
Intracranial Pressure Increase
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Monopolar hysteroscopy
Bipolar hysteroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Intracranial Pressure Increase
Eligibility Criteria
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
Sites / Locations
- Kanuni Sultan Suleyman Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Monopolar hysteroscopy
Bipolar hysteroscopy
Arm Description
This group of patients will receive Monopolar hysteroscopy for uterine distention.
This group of patients will receive Monopolar hysteroscopy for uterine distention.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04004923
First Posted
June 30, 2019
Last Updated
February 19, 2020
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04004923
Brief Title
Intracranial Pressure in Monopolar and Bipolar Hysteroscopy
Official Title
Monopolar or Bipolar Hysteroscopy: Comparison of the Impact of Two Methods on Intracranial Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
October 25, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Pressure Increase
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monopolar hysteroscopy
Arm Type
Active Comparator
Arm Description
This group of patients will receive Monopolar hysteroscopy for uterine distention.
Arm Title
Bipolar hysteroscopy
Arm Type
Active Comparator
Arm Description
This group of patients will receive Monopolar hysteroscopy for uterine distention.
Intervention Type
Procedure
Intervention Name(s)
Monopolar hysteroscopy
Intervention Description
Unipolar resectoscopes are used in this group and the distention fluid is mannitol
Intervention Type
Procedure
Intervention Name(s)
Bipolar hysteroscopy
Intervention Description
Bipolar resectoscopes are used in this group and the distention fluid is serum physiologic
Primary Outcome Measure Information:
Title
Intracranial pressure
Description
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.
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huseyin Kiyak, MD
Organizational Affiliation
Kanuni Sultan Suleyman Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
Istanbul
State/Province
Please Enter The State Or Province
ZIP/Postal Code
34005
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intracranial Pressure in Monopolar and Bipolar Hysteroscopy
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