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AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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?
None posted in the registry

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.

Neta Eisenberg Kogan, Doctor (MD) contact

+972542573878

netae@shamir.gov.il

Maayan Gal Kochav, Doctor (MD) contact

+972508683898

maayangk24@gmail.com

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).

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 groups in NCT06620978
Study groupRoleWhat they receive
Low pressureActive comparatorLow pressure (100 mmHg) Saline medium during hysteroscopy.
Receives: Procedure: Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure..
High pressureActive comparatorHigh 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.

  1. 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.

  2. 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)
  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.

  1. First posted1 Oct 2024
  2. Study start1 Nov 2024 (estimated)
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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)
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 24262433
  • De 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 33444792
  • Salazar 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

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: status not confirmed, 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?

Results are not available in the source record.

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.

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