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

Uterine Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02682433
• Other study ID #: 522-15
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 12, 2016
• Last updated: April 7, 2016
• Start date: April 2016
• Est. completion date: January 2018

Study information

• Verified date: April 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Gad Malinger, professor
• Phone: 052-4262123
• Email: gadm[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Purpose of the study:

Comparison of the sensitivity, specificity, and the amount of information between diagnostic hysteroscopy and sonohysterography (Two and three-dimensional, in abdominal and vaginal access).

The comparison will be will be made immediately after the completion of diagnostic hysteroscopy test, while using liquid drizzled earlier during the hysteroscopy, in order to simulate sonohysterography which is considered less intrusive and is made As part of standard treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Women aged 20 to 70 who were referred by a physician to perform diagnostic hysteroscopy.

Exclusion Criteria:

• refusal to sign a consent form

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Uterine Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference between US and hysteroscopy for the diagnosis and assessment of uterine cavity.	Comparison of structure of Uterine cavity, Is the uterine cavity normal? Yes/no	1 hour	Yes
Primary	The difference between US and hysteroscopy for the diagnosis and assessment of polyps	Is there a polyp? Yes/no	1 hour	Yes