3D Sonohysterography vs Hysteroscopy: Study for the Evaluation of Intrauterine Abnormalities

Summary

Uterine cavity diseases can cause mild to severe symptoms, and may indicate the functional problems of the female reproductive system. Many articles examine the efficacy of diagnostic hysteroscopy compared to sonohysterography in the diagnosis of uterine cavity diseases. Most of the articles are from the last decade, but the subject has been laid aside in the recent years. Antonio Simone Lagana and his group have found that there is 100% correlation in uterine cavity structure between diagnostic hysteroscopy and sonohysterography, and only 78% correlation when it comes to intrauterine fibroids and polyps. Walid El-Sherbiny, MD and his group have found that there is a significant advantage to three-dimensional sonohysterography over two-dimensional in the diagnosis of uterine cavity diseases. No significant difference was observed, and 97% correlation was found, comparing three-dimensional sonar and hysteroscopy. Work rationale is that there is a reason to reconsider the status of the diagnostic hysteroscopy to sonohysterography due to evolving technologies, and an improvement in resolution and three dimensional technologies.

Conditions

• Uterine Diseases

Interventions

DEVICE

diagnostic hysteroscopy

Women who were routinely referred to perform diagnostic hysteroscopy. As part of the procedure, clear liquid is inserted into the uterine cavity. After the hysteroscopy, abdominal and vaginal sonar will be performed, and the findings will be recorded and will be compared. Immediately after completion of the office hysteroscopy, two-dimensional and three-dimensional sonar to demonstrate the uterine cavity and its walls will be performed while using the liquid which is left in the uterine cavity. It is important to note that no additional invasive operation will be performed beyond what is necessary to perform hysteroscopy. It should be emphasized that the sonar test will be performed immediately and in the same position as the hysteroscopy test. All procedures will be performed in women clinics or day hospitalization. It should be noted that the medical examinations will not be performed unless there are medical reasons.

DEVICE

diagnostic sonar test

Women who were routinely referred to perform diagnostic hysteroscopy. As part of the procedure, clear liquid is inserted into the uterine cavity. After the hysteroscopy, abdominal and vaginal sonar will be performed, and the findings will be recorded and will be compared. Immediately after completion of the office hysteroscopy, two-dimensional and three-dimensional sonar to demonstrate the uterine cavity and its walls will be performed while using the liquid which is left in the uterine cavity. It is important to note that no additional invasive operation will be performed beyond what is necessary to perform hysteroscopy. It should be emphasized that the sonar test will be performed immediately and in the same position as the hysteroscopy test. All procedures will be performed in women clinics or day hospitalization. It should be noted that the medical examinations will not be performed unless there are medical reasons.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center

  lead OTHER_GOV

Principal Investigators

• Gad Malinger, professor · Tel Aviv Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2018-01-31

Completion

2018-01-31