4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Intracranial Pressure in Monopolar and Bipolar Hysteroscopy

Intracranial Pressure in Monopolar and Bipolar Hysteroscopy

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.

Condition or disease Intervention/treatment Phase
Intracranial Pressure Increase Procedure: Monopolar hysteroscopy Procedure: Bipolar hysteroscopy Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Monopolar or Bipolar Hysteroscopy: Comparison of the Impact of Two Methods on Intracranial Pressure
Actual Study Start Date : July 5, 2019
Actual Primary Completion Date : October 25, 2019
Actual Study Completion Date : October 30, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Monopolar hysteroscopy
This group of patients will receive Monopolar hysteroscopy for uterine distention.
 Procedure: Monopolar hysteroscopy
Unipolar resectoscopes are used in this group and the distention fluid is mannitol
Active Comparator: Bipolar hysteroscopy
This group of patients will receive Monopolar hysteroscopy for uterine distention.
 Procedure: Bipolar hysteroscopy
Bipolar resectoscopes are used in this group and the distention fluid is serum physiologic
Outcome Measures
Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
Turkey
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Please Enter The State Or Province, Turkey, 34005
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Investigators
Layout table for investigator information
Principal Investigator: Huseyin Kiyak, MD Kanuni Sultan Suleyman Hospital
Tracking Information
First Submitted Date  ICMJE June 30, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date February 20, 2020
Actual Study Start Date  ICMJE July 5, 2019
Actual Primary Completion Date October 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019) 		Intracranial presure [ 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 uding a linear ultrasound probe and reflects intracranial pressure.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intracranial Pressure in Monopolar and Bipolar Hysteroscopy
Official Title  ICMJE Monopolar or Bipolar Hysteroscopy: Comparison of the Impact of Two Methods on Intracranial Pressure
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Intracranial Pressure Increase
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Monopolar hysteroscopy
    This group of patients will receive Monopolar hysteroscopy for uterine distention.
    Intervention: Procedure: Monopolar hysteroscopy
  • Active Comparator: Bipolar hysteroscopy
    This group of patients will receive Monopolar hysteroscopy for uterine distention.
    Intervention: Procedure: Bipolar hysteroscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2020) 		80
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2019) 		55
Actual Study Completion Date  ICMJE October 30, 2019
Actual Primary Completion Date October 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04004923
Other Study ID Numbers  ICMJE Huseyin4
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Huseyin Kiyak, Kanuni Sultan Suleyman Training and Research Hospital
Study Sponsor  ICMJE Kanuni Sultan Suleyman Training and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Huseyin Kiyak, MD Kanuni Sultan Suleyman Hospital
PRS Account Kanuni Sultan Suleyman Training and Research Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯