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

NCT02682433 | Unknown Phase 3 DMC

• 1 other identifier: 522-15
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

• The difference between US and hysteroscopy for the diagnosis and assessment of polyps

  Is there a polyp? Yes/no

  1 hour

Study Arms (2)

diagnostic hysteroscopy

EXPERIMENTAL

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, and in the same position, 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 hysteroscopy

diagnostic sonar test

EXPERIMENTAL

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, and in the same positionabdominal 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

Interventions

diagnostic hysteroscopy DEVICE

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 hysteroscopy

diagnostic sonar test DEVICE

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

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• refusal to sign a consent form

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Conditions

Uterine Diseases

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Gad Malinger, professor

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gad Malinger, professor

CONTACT

052-4262123; gadm@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: February 15, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: April 8, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share