Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation

Completed

• Conditions: Menorrhagia

• Registration Number: NCT02584088
• Lead Sponsor: TriHealth Inc.

Brief Summary

* The study primarily aims to evaluate the post ablative endometrium and uterus using transvaginal ultrasound to provide descriptive information as to what may be expected in the 12 months after a NovaSure ablation. Investigators believe this knowledge will help them to determine when to proceed with further evaluation postoperatively or when to counsel patients on expectant management based on ultrasonographic findings.

* Secondary aims include correlation of ultrasonographic findings to demographic patient data.

Detailed Description

Heavy and irregular menses affects 9-14% of gynecologic patients. Surgical can be employed intervention is sought when medical management fails. Endometrial ablation or desiccation of the endometrium using minimally invasive instruments has been utilized in this scenario. The current mainstay intervention is non-resectoscopic radio frequency ablation. These procedures have high satisfaction rates (81 to 93%) similar to hysterectomy and leave up to 47% of patients amenorrheic. Post operative complications, both short and long term, and failure rates have been well studied. A limited number of studies have been performed to assess the histologic state of the post ablative endometrium and fewer assessing the radiographic appearance of the endometrium. Therefore, this current study aims to describe the ultrasonographic appearance of the post ablative endometrium and uterus.

Study Timeline

• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-22
• Study Start: 2016-10-11
• Primary Completion: 2021-11
• Study Completion: 2021-11
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• women of premenopausal age
• 18 years and older
• intended ablative management of menorrhagia

Exclusion Criteria

• uterine cavity anatomic abnormality
• previous uterine ablation procedure
• previous cervical procedure
• presence of submucosal fibroids
• tissue diagnosis of endometrial hyperplasia/endometrial carcinoma
• pregnancy and delivery less than 1 year before ablation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endometrial thickness (measured using a scale)	2 months

Trial Locations

Locations (2)

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States

Bethesda North Hospital; 🇺🇸 Cincinnati, Ohio, United States