Role of Office Hysteroscope in Premenopausal Uterine Bleeding

NCT ID: NCT03205111

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2018-07-31

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.

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.

Conditions

Uterine Bleeding

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Perimenopausal women complaining of abnormal uterine bleeding.

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Zaki Fahmi

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Z. Fahmi

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Essam M. Abdallah, Profosser

Role: STUDY_CHAIR

Assiut University

Hazem S. Mohammed, Professor

Role: STUDY_DIRECTOR

Assiut University

Kamal M. Zahran, Professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Ahmed Z. Fahmi

Role: CONTACT

ahmed_zaki_1985@yahoo.com

+201020440944

References

Bennett AR, Gray SH. What to do when she's bleeding through: the recognition, evaluation, and management of abnormal uterine bleeding in adolescents. Curr Opin Pediatr. 2014 Aug;26(4):413-9. doi: 10.1097/MOP.0000000000000121.

Reference Type: RESULT

PMID: 25007322 (View on PubMed)

Saadia A, Mubarik A, Zubair A, Jamal S, Zafar A. Diagnostic accuracy of endometrial curettage in endometrial pathology. J Ayub Med Coll Abbottabad. 2011 Jan-Mar;23(1):129-31.

Reference Type: RESULT

PMID: 22830167 (View on PubMed)

Zhu HL, Liang XD, Wang JL, Cui H, Wei LH. Hysteroscopy and directed biopsy in the diagnosis of endometrial carcinoma. Chin Med J (Engl). 2010 Dec;123(24):3524-8.

Reference Type: RESULT

PMID: 22166624 (View on PubMed)

Other Identifiers

Office Hysteroscope

Identifier Type: -

Identifier Source: org_study_id