Endometrial PolypsNCT06620978
Impact of Different Saline Pressures During Hysteroscopy on Visibility, Feasibility and Patients' Discomfort
A study testing Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure.. and High pressure: Operative hysteroscopy without anesthesia with normal Saline medium in High pressure. in people with Endometrial Polyps and Retained Products of Conception, run by Assaf-Harofeh Medical Center.
Trial summary
Hysteroscopy is a minimally invasive diagnostic and therapeutic procedure for various intrauterine conditions. It is performed with an optic device while entering liquid media to the uterus to allow visualization. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Polyps, Retained Products of Conception, Lysis of Intrauterine Adhesions
- What is being tested?
- Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure.. and High pressure: Operative hysteroscopy without anesthesia with normal Saline medium in High pressure.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 Dec 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women age \>18 years
- Willing to undergo operative hysteroscopy without anesthesia for
- The following intrauterine findings:
- Endometrial polyps \<1.5 cm B. Retained products of conception \<1.5 cm C. Lysis of intrauterine adhesions D. Removal of retained intrauterine device
Who cannot join
- Contraindication for hysteroscopy including: suspected pregnancy, heavy concomitant vaginal bleeding, known genital tract malignancy, suspected concurrent genital tract infection.
- Unable to sign informed consent
- Unable to read/write Hebrew
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Operative Hysteroscopy Without Anaesthesia: Impact of Different Distention Medium Pressure (Using Normal Saline) on Visibility, Feasibility and Patients' Discomfort
Hysteroscopy is a minimally invasive diagnostic and therapeutic procedure for various intrauterine conditions. It is performed with an optic device while entering liquid media to the uterus to allow visualization. Diagnostic procedures are often performed without anaesthesia (in the office setting) and operative procedures are performed either under general anaesthesia or without anaesthesia (in the office setting). It depends on the patients' characteristics and preferences, and surgical indications. 80%-100% of operative procedure without anesthesia can be successfully completed. The main reasons for inability to successfully complete operative hysteroscopy without anesthesia are patients' discomfort and limited visibility of the uterine cavity.
In the current study, the investigators will compare the use of two different pressure setting of the liquid media during operative hysteroscopy without anesthesia, with the aim of investigating the successful completion of the procedure and patient's discomfort, with the aim of determining the optimal pressure setting.
Read the detailed description
Hysteroscopy is a minimally invasive diagnostic and therapeutic procedure for various intrauterine conditions such as endometrial polyps, myomas, intrauterine adhesions, and retained products of conception. While the diagnostic procedures are often performed without anaesthesia (in the office setting), the operative procedures are performed either under general anaesthesia in the operative room, or without anaesthesia (in the office setting), depending on the patients' characterises and preferences, and surgical indications. In general, operative hysteroscopy without anaesthesia is offered to patients willing to undergo an awake operative procedure who have relatively small intrauterine pathologies (such as endometrial polyps and retained products of conception up to1.5 cm in diameter), mild intrauterine adhesions, and for removal of retained intrauterine device. In this setting, 80% to 100% of operative procedure without anesthesia can be successfully completed. The main reasons for inability to successfully complete operative hysteroscopy without anesthesia are patients' discomfort and limited visibility of the uterine cavity.
During hysteroscopy, distention of the uterine cavity with a distention medium is required to allow for optimal visualization. The uterine distention is an essential component of hysteroscopy, because the uterine cavity is a potential space which is normally collapsed. The most common distention medium for diagnostic and operative hysteroscopy is 0.9% normal saline. When the procedure is performed without anesthesia (i.e., in the office setting), some of the discomfort perceived by the patient is caused by the distention of the cavity. Obviously, longer procedures and the use of higher pressure of the distention medium are associated with greater patients' discomfort. On the other hand, the use of higher pressure may allow for better visualization of the uterine cavity, which may contribute to higher success rates of operative hysteroscopy without anesthesia. However, the optimal normal saline pressure which allows for adequate visualization of the uterine cavity and successful completion of operative hysteroscopy without anesthesia with acceptable patients' discomfort has not been determined to date. Previous studies have described the use of intrauterine pressure of normal saline for operative hysteroscopy without anesthesia in the range of 80 mmHg up to 150 mmHg.
In the current study, the investigators will compare the use of two different pressure setting for normal saline during operative hysteroscopy without anesthesia, with the aim of investigating the successful completion of the procedure, the surgeons' impression and the patient's discomfort, with the aim of determining the optimal pressure setting for these procedures.
Participation in the study will be offered to patients referred for operative hysteroscopy without anesthesia in the office setting in the outpatient service of the division of minimally invasive gynecologic surgery at the Shamir medical center department of obstetrics and gynecology. The indication for the surgery, surgical technique and instrumentation, and pre- and postoperative follow up will be identical to the standard procedures performed in our department in these cases. Patients will sign the standard informed consent form for operative hysteroscopy. Participants will be randomly assigned into the low pressure or the high pressure groups. The surgeons and the patients will be blinded to the pressure setting which will be set up by the assisting nurse. Following the procedure, the surgeon will fill a questionnaire regarding the feasibility of the procedure and the uterine cavity visibility (appendix 1). The intraoperative pain will be determined using a Visual analog scale (VAS).
- Conditions
- Endometrial Polyps, Retained Products of Conception, Lysis of Intrauterine Adhesions, Removal of Retained Intrauterine Device
- Being tested
- Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure.., High pressure: Operative hysteroscopy without anesthesia with normal Saline medium in High pressure.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure..Procedure or surgery
Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure..
Operative hysteroscopy without anesthesia using normal Saline as medium with different pressure according to the arm allocated. The procedure is done for endometrial polyp removal, retained products of conception removal, intrauterine adhesyolisis and intrauterine device removal.
High pressure: Operative hysteroscopy without anesthesia with normal Saline medium in High pressure.Procedure or surgery
High pressure: Operative hysteroscopy without anesthesia with normal Saline medium at high pressure.
| Study group | Role | What they receive |
|---|---|---|
| Low pressure | Active comparator | Low pressure (100 mmHg) Saline medium during hysteroscopy. Receives: Procedure: Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure.. |
| High pressure | Active comparator | High pressure (150 mmHg) Saline medium during hysteroscopy. Receives: Procedure: High pressure: Operative hysteroscopy without anesthesia with normal Saline medium in High pressure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the rate of successful completion rate of operative hysteroscopy without anesthesia using low pressure (100 mmHg) versus high pressure (150 mmHg) normal saline for distention medium.
The feasibility and success of the procedure would be evaluated by the surgeon using a questionnaire.
Measured: The questionnaire will be filled immediately after the procedure.
Feasibility and uterine cavity visibility of operative hysteroscopy without anesthesia using low versus high pressure normal saline for distention medium.
Feasibility and uterine cavity visibility of operative hysteroscopy without anesthesia using low pressure (100 mmHg) versus high pressure (150 mmHg) normal saline for distention medium. The feasibility of the procedure would be evaluated by the surgeon using a questionnaire.
Measured: The questionnaire will be filled immediately after the procedure.
Secondary outcomes (1)
Patients' discomfort during operative hysteroscopy without anesthesia using low versus high pressure normal saline for distention medium.
Patients' discomfort during operative hysteroscopy without anesthesia using low pressure (100 mmHg) versus high pressure (150 mmHg) normal saline for distention medium measured by VAS.
Measured: Visual Analog Scale (VAS) will be filled immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endometrial PolypsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Neta Eisenberg Kogan, Assaf-Harofeh Medical Center
- Investigators
- Neta Eisenberg Kogan, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620978
- Sponsor's protocol ID
- 134-24-ASF
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected and summarized by excel shits will be shared
Publications
Shahid A, Pathak M, Gulumser C, Parker S, Palmer E, Saridogan E. Optimum uterine filling pressure for outpatient diagnostic hysteroscopy: a double-blind, randomized controlled trial. Reprod Biomed Online. 2014 Jan;28(1):86-91. doi: 10.1016/j.rbmo.2013.07.018. Epub 2013 Sep 14.
PubMed 24262433De Silva PM, Stevenson H, Smith PP, Justin Clark T. A Systematic Review of the Effect of Type, Pressure, and Temperature of the Distension Medium on Pain During Office Hysteroscopy. J Minim Invasive Gynecol. 2021 Jun;28(6):1148-1159.e2. doi: 10.1016/j.jmig.2021.01.003. Epub 2021 Jan 11.
PubMed 33444792Salazar CA, Isaacson KB. Office Operative Hysteroscopy: An Update. J Minim Invasive Gynecol. 2018 Feb;25(2):199-208. doi: 10.1016/j.jmig.2017.08.009. Epub 2017 Aug 10.
PubMed 28803811
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative Hysteroscopy Without Anaesthesia: Impact of Different Distention Medium Pressure (Using Normal Saline) on Visibility, Feasibility and Patients' Discomfort
- ClinicalTrials.gov ID
- NCT06620978
- Acronym / sponsor ID
- 134-24-ASF
- Conditions
- Endometrial Polyps, Retained Products of Conception, Lysis of Intrauterine Adhesions, Removal of Retained Intrauterine Device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Oct 2024 (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.
Hysteroscopy is a minimally invasive diagnostic and therapeutic procedure for various intrauterine conditions. It is performed with an optic device while entering liquid media to the uterus to allow visualization. Diagnostic procedures are often performed without anaesthesia (in the office setting) and operative procedures are performed either under general anaesthesia or without anaesthesia (in the office setting). It depends on the patients' characteristics and preferences, and surgical indications. 80%-100% of operative procedure without anesthesia can be successfully completed. The main reasons for inability to successfully complete operative hysteroscopy without anesthesia are patients' discomfort and limited visibility of the uterine cavity.
In the current study, the investigators will compare the use of two different pressure setting of the liquid media during operative hysteroscopy without anesthesia, with the aim of investigating the successful completion of the procedure and patient's discomfort, with the aim of determining the optimal pressure setting.
Detailed description
Hysteroscopy is a minimally invasive diagnostic and therapeutic procedure for various intrauterine conditions such as endometrial polyps, myomas, intrauterine adhesions, and retained products of conception. While the diagnostic procedures are often performed without anaesthesia (in the office setting), the operative procedures are performed either under general anaesthesia in the operative room, or without anaesthesia (in the office setting), depending on the patients' characterises and preferences, and surgical indications. In general, operative hysteroscopy without anaesthesia is offered to patients willing to undergo an awake operative procedure who have relatively small intrauterine pathologies (such as endometrial polyps and retained products of conception up to1.5 cm in diameter), mild intrauterine adhesions, and for removal of retained intrauterine device. In this setting, 80% to 100% of operative procedure without anesthesia can be successfully completed. The main reasons for inability to successfully complete operative hysteroscopy without anesthesia are patients' discomfort and limited visibility of the uterine cavity.
During hysteroscopy, distention of the uterine cavity with a distention medium is required to allow for optimal visualization. The uterine distention is an essential component of hysteroscopy, because the uterine cavity is a potential space which is normally collapsed. The most common distention medium for diagnostic and operative hysteroscopy is 0.9% normal saline. When the procedure is performed without anesthesia (i.e., in the office setting), some of the discomfort perceived by the patient is caused by the distention of the cavity. Obviously, longer procedures and the use of higher pressure of the distention medium are associated with greater patients' discomfort. On the other hand, the use of higher pressure may allow for better visualization of the uterine cavity, which may contribute to higher success rates of operative hysteroscopy without anesthesia. However, the optimal normal saline pressure which allows for adequate visualization of the uterine cavity and successful completion of operative hysteroscopy without anesthesia with acceptable patients' discomfort has not been determined to date. Previous studies have described the use of intrauterine pressure of normal saline for operative hysteroscopy without anesthesia in the range of 80 mmHg up to 150 mmHg.
In the current study, the investigators will compare the use of two different pressure setting for normal saline during operative hysteroscopy without anesthesia, with the aim of investigating the successful completion of the procedure, the surgeons' impression and the patient's discomfort, with the aim of determining the optimal pressure setting for these procedures.
Participation in the study will be offered to patients referred for operative hysteroscopy without anesthesia in the office setting in the outpatient service of the division of minimally invasive gynecologic surgery at the Shamir medical center department of obstetrics and gynecology. The indication for the surgery, surgical technique and instrumentation, and pre- and postoperative follow up will be identical to the standard procedures performed in our department in these cases. Patients will sign the standard informed consent form for operative hysteroscopy. Participants will be randomly assigned into the low pressure or the high pressure groups. The surgeons and the patients will be blinded to the pressure setting which will be set up by the assisting nurse. Following the procedure, the surgeon will fill a questionnaire regarding the feasibility of the procedure and the uterine cavity visibility (appendix 1). The intraoperative pain will be determined using a Visual analog scale (VAS).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low pressure | Active comparator | Procedure: Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure..Low pressure (100 mmHg) Saline medium during hysteroscopy. |
| High pressure | Active comparator | Procedure: High pressure: Operative hysteroscopy without anesthesia with normal Saline medium in High pressure.High pressure (150 mmHg) Saline medium during hysteroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women age \>18 years
- Willing to undergo operative hysteroscopy without anesthesia for
- Endometrial polyps \<1.5 cm B. Retained products of conception \<1.5 cm C. Lysis of intrauterine adhesions D. Removal of retained intrauterine device
Key exclusion criteria (3 listed)
- Contraindication for hysteroscopy including: suspected pregnancy, heavy concomitant vaginal bleeding, known genital tract malignancy, suspected concurrent genital tract infection.
- Unable to sign informed consent
- Unable to read/write Hebrew
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 |
|---|---|---|
| Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure..Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure.. Operative hysteroscopy without anesthesia using normal Saline as medium with different pressure according to the arm allocated. The procedure is done for endometrial polyp removal, retained products of conception removal, intrauterine adhesyolisis and intrauterine device removal. | Procedure or surgery | Low pressure |
| High pressure: Operative hysteroscopy without anesthesia with normal Saline medium in High pressure.High pressure: Operative hysteroscopy without anesthesia with normal Saline medium at high pressure. | Procedure or surgery | High pressure |
Primary outcome
To compare the rate of successful completion rate of operative hysteroscopy without anesthesia using low pressure (100 mmHg) versus high pressure (150 mmHg) normal saline for distention medium.
Time frame: The questionnaire will be filled immediately after the procedure.
The feasibility and success of the procedure would be evaluated by the surgeon using a questionnaire.
Feasibility and uterine cavity visibility of operative hysteroscopy without anesthesia using low versus high pressure normal saline for distention medium.
Time frame: The questionnaire will be filled immediately after the procedure.
Feasibility and uterine cavity visibility of operative hysteroscopy without anesthesia using low pressure (100 mmHg) versus high pressure (150 mmHg) normal saline for distention medium. The feasibility of the procedure would be evaluated by the surgeon using a questionnaire.
1 secondary outcome
Patients' discomfort during operative hysteroscopy without anesthesia using low versus high pressure normal saline for distention medium.
Time frame: Visual Analog Scale (VAS) will be filled immediately after the procedure.
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 2 Oct 2024.
- Background: PubMed 24262433Shahid A, Pathak M, Gulumser C, Parker S, Palmer E, Saridogan E. Optimum uterine filling pressure for outpatient diagnostic hysteroscopy: a double-blind, randomized controlled trial. Reprod Biomed Online. 2014 Jan;28(1):86-91. doi: 10.1016/j.rbmo.2013.07.018. Epub 2013 Sep 14.
- Background: PubMed 33444792De Silva PM, Stevenson H, Smith PP, Justin Clark T. A Systematic Review of the Effect of Type, Pressure, and Temperature of the Distension Medium on Pain During Office Hysteroscopy. J Minim Invasive Gynecol. 2021 Jun;28(6):1148-1159.e2. doi: 10.1016/j.jmig.2021.01.003. Epub 2021 Jan 11.
- Background: PubMed 28803811Salazar CA, Isaacson KB. Office Operative Hysteroscopy: An Update. J Minim Invasive Gynecol. 2018 Feb;25(2):199-208. doi: 10.1016/j.jmig.2017.08.009. Epub 2017 Aug 10.
- Enter the website. Type \&#34;Hysteroscopy managing fluid and gas distending media\&#34;.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data collected and summarized by excel shits will be shared
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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.
Neta Eisenberg Kogan principal investigator
Assaf-Harofeh Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure.. and High pressure: Operative hysteroscopy without anesthesia with normal Saline medium in High pressure. in people with Endometrial Polyps and Retained Products of Conception, run by Assaf-Harofeh Medical Center.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Neta Eisenberg Kogan, Doctor (MD) (+972542573878, netae@shamir.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the rate of successful completion rate of operative hysteroscopy without anesthesia using low pressure (100 mmHg) versus high pressure (150 mmHg) normal saline for distention medium. (time frame: The questionnaire will be filled immediately after the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06620978, which also lists 3 linked publications.
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 2 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.