Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy
1 other identifier
interventional
244
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Sep 2023
Longer than P75 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2023
CompletedFirst Posted
Study publicly available on registry
August 2, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
August 14, 2025
August 1, 2025
3.1 years
July 25, 2023
August 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-operative pain
Post operative pain will evalute with numeric pain rating scale The scale is scored from 0 to 10. 0 means no pain and 10 means the most severe pain experienced.
3 hours
Secondary Outcomes (1)
Post operavite Na Value Change
1 minute
Study Arms (2)
24 Centigrade Degree
ACTIVE COMPARATOROperative hysteroscopy will be performed at room temperature distention medium.
37 Centigrade Degree
ACTIVE COMPARATOROperative hysteroscopy will be performed using a heated distention medium.
Interventions
Operative hysteroscopy will be performed at room temperature distention medium.
Operative hysteroscopy will be performed using a heated distention medium.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Active vaginal, and cervical infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ege Universitylead
Study Sites (1)
Sabahattin Anil Ari
Izmir, 35000, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sabahattin A Ari, Asst. Prof.
Izmir Bakircay University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asst. Prof.
Study Record Dates
First Submitted
July 25, 2023
First Posted
August 2, 2023
Study Start
September 1, 2023
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
August 14, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
IPD will not be published.