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Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy

Primary Purpose

Post-operative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Operative Hysteroscopy 24 Centigrade Degree
Operative Hysteroscopy 37 Centigrade Degree
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring hysteroscopy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: To be planned for operative hysteroscopy due to an endometrial polyp or type 0-1 myoma in the range of 2-3 cm Having a vaginal delivery at least once before Ability to communicate adequately in Turkish or English Exclusion Criteria: Pregnancy Active vaginal, and cervical infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    24 Centigrade Degree

    37 Centigrade Degree

    Arm Description

    Operative hysteroscopy will be performed at room temperature distention medium.

    Operative hysteroscopy will be performed using a heated distention medium.

    Outcomes

    Primary Outcome Measures

    Post-operative pain
    Post operative pain will evalute with numeric pain rating scale

    Secondary Outcome Measures

    Post operavite Na Value
    Post-operative blood Na value will be checked.

    Full Information

    First Posted
    July 25, 2023
    Last Updated
    July 25, 2023
    Sponsor
    Ege University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05973045
    Brief Title
    Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy
    Official Title
    Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk and Post-operative Pain in Operative Hysteroscopy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2025 (Anticipated)
    Study Completion Date
    September 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ege University

    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
    Minimally invasive applications are seen as the gold standard in today's gynecology practice and are frequently preferred by both patients and physicians. Less pain, shorter hospital stays, and better cosmetic results brought about by minimally invasive applications further increase their preference. One of these approaches is hysteroscopic interventions. Although hysteroscopy is a well-defined method, current research has focused on further reduction of pain. One of these methods is to warm the distention media at body temperature. theTaim of this study was to examine the effect of distention medium temperature on image quality, hyponatremia risk, and post-operative pain in operative hysteroscopy.
    Detailed Description
    Minimally invasive applications are seen as the gold standard in today's gynecology practice and are frequently preferred by both patients and physicians. Less pain, shorter hospital stays, and better cosmetic results brought about by minimally invasive applications further increase their preference. One of these approaches is hysteroscopic interventions. Although hysteroscopy is a well-defined method, current research has focused on further reduction of pain. One of these methods is to warm the distention media at body temperature. The optimum distention medium temperature has not been determined in the "Best Practice in Outpatient Hysteroscopy Green Top Guideline" organized by The Royal College of Obstetricians and Gynecologists and "Guideline on Management of Fluid Distension Media in Operative Hysteroscopy" organized by the European Society of Gynecological Endoscopy (1,2). In routine practice, some physicians use distention fluid at room temperature, while others use it by warming it at body temperature. It is known that colder fluids cause irregular contractions in the uterus (3). In prospective studies, the effects of heating distention media at body temperature on pain were reported inconsistently (3,4). As clear data could not be obtained, the risk of further intravasation and hyponatremia that may occur with the image quality and, more importantly, the heating of the fluid was ignored. But; Freitas Fonseca et al. In his in vitro study in Brazil, it was shown by theoretical calculations that heating hysteroscopy irrigation fluids from 270C to 370C increased intravasation by 53%. In light of the literature, and based on the ideas and possible risks in question, the aim of this study was to examine the effect of distention medium temperature on image quality, hyponatremia risk, and post-operative pain in operative hysteroscopy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-operative Pain
    Keywords
    hysteroscopy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective Randomized Controlled Clinical Study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    244 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    24 Centigrade Degree
    Arm Type
    Active Comparator
    Arm Description
    Operative hysteroscopy will be performed at room temperature distention medium.
    Arm Title
    37 Centigrade Degree
    Arm Type
    Active Comparator
    Arm Description
    Operative hysteroscopy will be performed using a heated distention medium.
    Intervention Type
    Procedure
    Intervention Name(s)
    Operative Hysteroscopy 24 Centigrade Degree
    Intervention Description
    Operative hysteroscopy will be performed at room temperature distention medium.
    Intervention Type
    Procedure
    Intervention Name(s)
    Operative Hysteroscopy 37 Centigrade Degree
    Intervention Description
    Operative hysteroscopy will be performed using a heated distention medium.
    Primary Outcome Measure Information:
    Title
    Post-operative pain
    Description
    Post operative pain will evalute with numeric pain rating scale
    Time Frame
    3 hours
    Secondary Outcome Measure Information:
    Title
    Post operavite Na Value
    Description
    Post-operative blood Na value will be checked.
    Time Frame
    1 minute

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To be planned for operative hysteroscopy due to an endometrial polyp or type 0-1 myoma in the range of 2-3 cm Having a vaginal delivery at least once before Ability to communicate adequately in Turkish or English Exclusion Criteria: Pregnancy Active vaginal, and cervical infection
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sabahattin A Ari, Asst. Prof.
    Phone
    +905547139994
    Email
    s.anil.ari.md@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sabahattin A Ari, Asst. Prof.
    Organizational Affiliation
    Izmir Bakircay University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD will not be published.

    Learn more about this trial

    Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy

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