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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAssaf-Harofeh Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women age >18 years

Willing to undergo operative hysteroscopy without anesthesia for

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/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/Surgery

    High pressure: Operative hysteroscopy without anesthesia with normal Saline medium at high pressure.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Low pressureActive comparator 1 intervention
Group B: High pressureActive comparator 1 intervention

Trial outcomes

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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