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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hysteroscopic Surgery in Treatment of Intrauterine Abnormalities

NCT03265301

Hysteroscopy

WITHDRAWN NA

The Effect of Preoperative Animated Videos on Anxiety in Patients Undergoing Hysteroscopy Without Anesthesia

NCT06625567

Anxiety

COMPLETED NA

Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques

NCT01376934

Postmenopausal Women Hysteroscopy

UNKNOWN NA

Solution Temperature and Fluid Deficit During Hysteroscopy

NCT05622097

Surgery

COMPLETED NA

Managing Outpatient Hysteroscopy-associated Pain

NCT05801172

Pain Hysteroscopic Surgery

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low pressure

Low pressure (100 mmHg) Saline medium during hysteroscopy.

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

High pressure (150 mmHg) Saline medium during hysteroscopy.

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No