Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02682433
Other study ID # 522-15
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05613816 - Prospective Data Collection to Compare RAL for Hysterectomies and Other Indications in to Conventional Laparoscopy
Not yet recruiting NCT02868437 - Effectiveness of Hyaluronic Acid Gel in the Prevention of Intrauterine Adhesions After Second Trimester Abortion Phase 4
Completed NCT00341458 - Breast Cancer in Poland: An Expanded Study to Assess Occupational and Environmental Factors and Interactions With Genetics
Completed NCT03093675 - Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study N/A
Recruiting NCT05823935 - Laparoscopic Versus Vaginal Cuff Closure During LH in Benign Gynecological Lesions N/A
Completed NCT04679675 - Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial N/A
Completed NCT04436354 - The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy N/A
Terminated NCT03827824 - Virtual Reality on Perception of Pain and Anxiety by Hysteroscopy N/A
Completed NCT03861195 - Comparative Prospective Data Collection in Connection With Two Different Treatment Methods: Robotic Assisted Laparoscopy and Conventional Laparoscopy
Completed NCT00793260 - Deep Dive Randomized Control Trial N/A
Completed NCT04808583 - Uterine Artery Ligation at Origin in Total Laparscopic Hystrectomy N/A
Withdrawn NCT04184323 - SIRT-1 Antagonism for Endometrial Receptivity Phase 2
Completed NCT04571671 - Do müllerian Anomalies Affect Embryo Implantation?
Completed NCT00000612 - Soy Estrogen Alternative Study (SEA) Phase 2
Active, not recruiting NCT05453006 - HPV Self-Sampling in Somali Women N/A
Completed NCT02631837 - Hysterectomy by Transabdominal Laparoscopy or NOTES N/A
Recruiting NCT05533710 - Comparison Between Erector Spinae Plane Block and Transversus Abdominis Plane Block on Postoperative Analgesia After Total Abdominal Hysterectomy N/A
Recruiting NCT04061967 - SMS-based Summons in Cervical Screening N/A
Recruiting NCT06019039 - Power Doppler Ultrasonography in Localization of Epidural Catheter