CClinicalTrials.gg
Not yet recruitingNCT06620978Updated Oct 2, 2024

Impact of Different Saline Pressures During Hysteroscopy on Visibility, Feasibility and Patients' Discomfort

An interventional study of 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 Endometrial Polyps, Retained Products of Conception and Lysis of Intrauterine Adhesions, sponsored by Assaf-Harofeh Medical Center. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-02.

Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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. 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).

02

Conditions studied

  • Endometrial Polyps
  • Retained Products of Conception
  • Lysis of Intrauterine Adhesions
  • Removal of Retained Intrauterine Device

Browse trials for

03

In context

Tissue Adhesions

241 studies on the registry are indexed under Tissue Adhesions; 29 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 184 interventional studies indexed under Tissue Adhesions.

Browse Tissue Adhesions studies →

Lead sponsor

Assaf-Harofeh Medical Center is the lead sponsor of 258 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Women age >18 years
  2. Willing to undergo operative hysteroscopy without anesthesia for

The following intrauterine findings:

A. Endometrial polyps \<1.5 cm B. Retained products of conception \<1.5 cm C. Lysis of intrauterine adhesions D. Removal of retained intrauterine device

Exclusion criteria

Exclusion Criteria:

  1. Contraindication for hysteroscopy including: suspected pregnancy, heavy concomitant vaginal bleeding, known genital tract malignancy, suspected concurrent genital tract infection.
  2. Unable to sign informed consent
  3. Unable to read/write Hebrew
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Low pressure

    Low pressure (100 mmHg) Saline medium during hysteroscopy.

    Procedure: Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure..

  • Active comparator
    High pressure

    High pressure (150 mmHg) Saline medium during hysteroscopy.

    Procedure: High pressure: Operative hysteroscopy without anesthesia with normal Saline medium in High pressure.

Interventions

  • ProcedureLow 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.

  • ProcedureHigh 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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Visual Analog Scale (VAS) will be filled immediately after the procedure.

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: Yes — Data collected and summarized by excel shits will be shared

Supporting information: Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06620978
Lead sponsor
Assaf-Harofeh Medical Center
Responsible party
Neta Eisenberg Kogan (Attending physician in the gynecology endoscopic unit, Assaf-Harofeh Medical Center) — Principal investigator
First posted
Oct 1, 2024
Start date
Nov 1, 2024 (estimated)
Primary completion
Sep 1, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Oct 2, 2024

Study contacts

Neta Eisenberg Kogan, Doctor (MD)
Contact
netae@shamir.gov.il
+972542573878
Maayan Gal Kochav, Doctor (MD)
Contact
maayangk24@gmail.com
+972508683898
Neta Eisenberg Kogan
principal investigator · Assaf-Harofeh Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion