Post-operative PainNCT05973045
Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy
A study testing Operative Hysteroscopy 24 Centigrade Degree and Operative Hysteroscopy 37 Centigrade Degree in people with Post-operative Pain, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Operative Hysteroscopy 24 Centigrade Degree and Operative Hysteroscopy 37 Centigrade Degree
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Active vaginal, and cervical infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sabahattin Anil Ari
Izmir, 35000
Sabahattin Anil Ari, Asst. Prof., +905547139994, s.anil.ari.md@gmail.com
About this study
Official title: Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk and Post-operative Pain in Operative Hysteroscopy
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.
Read the 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. 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. In prospective studies, the effects of heating distention media at body temperature on pain were reported inconsistently. 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.
- Conditions
- Post-operative Pain
- Being tested
- Operative Hysteroscopy 24 Centigrade Degree, Operative Hysteroscopy 37 Centigrade Degree
- Keywords
- hysteroscopy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operative Hysteroscopy 24 Centigrade DegreeProcedure or surgery
Operative hysteroscopy will be performed at room temperature distention medium.
Operative Hysteroscopy 37 Centigrade DegreeProcedure or surgery
Operative hysteroscopy will be performed using a heated distention medium.
| Study group | Role | What they receive |
|---|---|---|
| 24 Centigrade Degree | Active comparator | Operative hysteroscopy will be performed at room temperature distention medium. Receives: Procedure: Operative Hysteroscopy 24 Centigrade Degree |
| 37 Centigrade Degree | Active comparator | Operative hysteroscopy will be performed using a heated distention medium. Receives: Procedure: Operative Hysteroscopy 37 Centigrade Degree |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 hours
Secondary outcomes (1)
Post operavite Na Value Change
Post-operative blood Na value will be checked.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Sep 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Controlled Clinical Study
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabahattin Anıl Arı, Izmir Bakircay University
- Investigators
- Sabahattin A Ari, Asst. Prof., Principal investigator, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973045
- Sponsor's protocol ID
- 617
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be published.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk and Post-operative Pain in Operative Hysteroscopy
- ClinicalTrials.gov ID
- NCT05973045
- Acronym / sponsor ID
- 617
- Conditions
- Post-operative Pain
- Keywords
- hysteroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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. In prospective studies, the effects of heating distention media at body temperature on pain were reported inconsistently. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Randomized Controlled Clinical Study
| Arm | Type | Receives |
|---|---|---|
| 24 Centigrade Degree | Active comparator | Procedure: Operative Hysteroscopy 24 Centigrade DegreeOperative hysteroscopy will be performed at room temperature distention medium. |
| 37 Centigrade Degree | Active comparator | Procedure: Operative Hysteroscopy 37 Centigrade DegreeOperative hysteroscopy will be performed using a heated distention medium. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- Active vaginal, and cervical infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Operative Hysteroscopy 24 Centigrade DegreeOperative hysteroscopy will be performed at room temperature distention medium. | Procedure or surgery | 24 Centigrade Degree |
| Operative Hysteroscopy 37 Centigrade DegreeOperative hysteroscopy will be performed using a heated distention medium. | Procedure or surgery | 37 Centigrade Degree |
Primary outcome
Post-operative pain
Time frame: 3 hours
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.
1 secondary outcome
Post operavite Na Value Change
Time frame: 1 minute
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No. IPD will not be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabahattin A Ari, Asst. Prof. principal investigator
Izmir Bakircay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operative Hysteroscopy 24 Centigrade Degree and Operative Hysteroscopy 37 Centigrade Degree in people with Post-operative Pain, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabahattin A Ari, Asst. Prof. (+905547139994, s.anil.ari.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.