The Role of TVSG and HS in Determining Endometrial Pathologies

NCT03441087 | Completed

• 1 other identifier: 349
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

Brief Summary

Although hysteroscopy (HS) and transvaginal ultrasonography (TVSG) are methods in the diagnosis of AUB, there is some suspicion about their efficacy. The aim of this study was to determine the efficacy and safety of HS and TVSG on diagnosing abnormal uterine bleeding(AUB) .216 women admitted to the investigators clinic (Sisli Ethal Training and Research Hospital, Obstetrics and Gynecology Department Obstetrics Service ) between 21-51 years of age. These patients were divided into two groups; menopause (71women) and pre-menopause (145 women). HS and endometrial sampling were performed both groups after TVSG.The success of these methods was assessed by kappa analysis

Conditions

Abnormal Uterine Bleeding

Keywords

transvaginal ultrasonography; hysteroscopy; abnormal uterine bleeding

Outcome Measures

Primary Outcomes (1)

• accuracy of diagnostic performance transvaginal ultrasonography and hysteroscopy

  The main outcome variable of the study was accuracy of diagnostic performance of transvaginal ultrasonography and hysteroscopy in premenopausal and menopausal women with abnormal uterin bleeding .

  up to 12 month

Study Arms (2)

Transvaginal ultrasound

OTHER

Transvaginal ultrasound was applied 216 women with abnormal uterine bleeding.The transvaginal ultrasound diagnoses were compared with the received endometrial samples.

Device: Transvaginal ultrasound

Hysteroscopy

OTHER

Hysteroscopy was also performed under general anesthesia.Hysteroscopy was performed by a single operator (NNY).The operator and two supervising endoscopists were blinded to the ultrasound results.After the hysteroscopy, endometrial sampling was also done. The diagnoses were compared with the received endometrial samples.

Device: Hysteroscopy

Interventions

Transvaginal ultrasound DEVICE

Transvaginal ultrasound

Hysteroscopy DEVICE

Hysteroscopy

Eligibility Criteria

• Age: 21 Years - 51 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients who have no history of hysteroscopy and curettage,
• patients who have no history of ovulatory dysfunction
• women who have active vaginal bleeding.

You may not qualify if:

• presence of genital infections/PID
• presence of pregnancy
• presence of vaginal or cervical pathology causing vaginal bleeding
• women who are receiving hormonal treatment (COC/HRT)
• patients formerly diagnosed with endometrial pathology
• patients having coagulopathy
• women who are using intrauterine device.

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

MeSH Terms

Conditions

Metrorrhagia

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

• Nefise Nazlı YENIGUL, MD

  Sisli Etfal Research and Training hospital, Obstetrics and gynecology department Istanbul, Marmara Turkey

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator MD

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 22, 2018
• Study Start: January 1, 2011
• Primary Completion: December 31, 2011
• Study Completion: December 31, 2011
• Last Updated: February 26, 2018

Record last verified: 2018-02