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