Role of Office Hysteroscope in Premenopausal Uterine Bleeding

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03205111

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of this study is to photographically characterize the endometrium in patients presenting with abnormal uterine bleeding at age group from 20 to 45 years old.

and compare dilatation and curettage with hysteroscopy in obtaining an accurate diagnosis of the etiology of abnormal uterine bleeding.

Condition or Disease	Intervention/Treatment	Phase
Uterine Bleeding

Detailed Description

Menstrual dysfunction is the cause of discomfort and disturbed healthy lifestyle. Abnormal uterine bleeding (AUB) is considered as a common problem in premenopausal women. AUB is defined as bleeding from the uterine that is abnormal in volume, regularity, and/or timing.

There are various diagnostic modalities available in the market, ranging from traditional dilation and curettage (D&C), transvaginal sonography, hysteroscopy and saline infusion sonography. Dilation and curettage is the most widely used simple day care procedure for histological evaluation of the endometrial. It was once considered as the gold standard of investigating women with AUB.

Office hysteroscopy is a very useful technique for diagnosis and treatment of uterine pathology in an office-based environment. It is directly related to the technological explosion, which during the last years has further evolved and given us the opportunity to perform hysteroscopy without providing general anesthesia or sedation to the patients, due to the narrow width of the latest generation hysteroscopes. Hysteroscopic inspection of uterine cavity is a simple and well accepted method. The direct real time visualization, real-color, hydrated, well-illuminated, and augmented vision of the uterine cavity make this diagnostic tool very accurate to detect minute focal endometrial pathology and small lesions and helping us to take well guided direct biopsies.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

Endometrial Characterization Using Office Hysteroscopy in Women Presenting With Abnormal Uterine Bleeding

Anticipated Study Start Date :

Jul 1, 2017

Anticipated Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Jul 1, 2018

Outcome Measures

Primary Outcome Measures

Hysteroscopic assessment of endometrial pathology [7 days]
Patterns of endometrial pathology after histopathological examination of the curretings in patients with abnormal uterine bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Inclusion Criteria:

Perimenopausal women complaining of abnormal uterine bleeding.

Exclusion Criteria:

Active pelvic infections
Medical disorders
Bleeding tendency
Hormonal treatment
Pregnancy
Contraceptive treatment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Principal Investigator: Ahmed Z. Fahmi, Assiut University
Study Chair: Essam M. Abdallah, Profosser, Assiut University
Study Director: Hazem S. Mohammed, Professor, Assiut University
Study Director: Kamal M. Zahran, Professor, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Zaki Fahmi, Dr, Assiut University

ClinicalTrials.gov Identifier:

NCT03205111

Other Study ID Numbers:

Office Hysteroscope

First Posted:

Jul 2, 2017

Last Update Posted:

Jul 2, 2017

Last Verified:

Jun 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Uterine Hemorrhage

Hemorrhage

Study Results

No Results Posted as of Jul 2, 2017