Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation

NCT ID: NCT02584088

Last Updated: 2022-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-11

Study Completion Date

2021-11-30

Brief Summary

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* 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

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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.

Conditions

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Menorrhagia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Ultrasound

The appearance of the post ablative endometrium on transvaginal ultrasound at 2, 6, and 12 months.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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TriHealth Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catrina Crisp, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

TriHealth Inc.

Locations

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Good Samaritan Hospital

Cincinnati, Ohio, United States

Site Status

Bethesda North Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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El-Nashar SA, Hopkins MR, Creedon DJ, St Sauver JL, Weaver AL, McGree ME, Cliby WA, Famuyide AO. Prediction of treatment outcomes after global endometrial ablation. Obstet Gynecol. 2009 Jan;113(1):97-106. doi: 10.1097/AOG.0b013e31818f5a8d.

Reference Type BACKGROUND
PMID: 19104365 (View on PubMed)

Dickersin K, Munro MG, Clark M, Langenberg P, Scherer R, Frick K, Zhu Q, Hallock L, Nichols J, Yalcinkaya TM; Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB) Research Group. Hysterectomy compared with endometrial ablation for dysfunctional uterine bleeding: a randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1279-89. doi: 10.1097/01.AOG.0000292083.97478.38.

Reference Type BACKGROUND
PMID: 18055721 (View on PubMed)

Alhilli MM, Wall DJ, Brown DL, Weaver AL, Hopkins MR, Famuyide AO. Uterine ultrasound findings after radiofrequency endometrial ablation: correlation with symptoms. Ultrasound Q. 2012 Dec;28(4):261-8. doi: 10.1097/RUQ.0b013e318276653b.

Reference Type BACKGROUND
PMID: 23149510 (View on PubMed)

Ahonkallio SJ, Liakka AK, Martikainen HK, Santala MJ. Feasibility of endometrial assessment after thermal ablation. Eur J Obstet Gynecol Reprod Biol. 2009 Nov;147(1):69-71. doi: 10.1016/j.ejogrb.2009.06.014. Epub 2009 Jul 16.

Reference Type BACKGROUND
PMID: 19615812 (View on PubMed)

Penninx JPM, Herman MC, Mol BW, Bongers MY. Five-year follow-up after comparing bipolar endometrial ablation with hydrothermablation for menorrhagia. Obstet Gynecol. 2011 Dec;118(6):1287-1292. doi: 10.1097/AOG.0b013e318236f7ed.

Reference Type BACKGROUND
PMID: 22105257 (View on PubMed)

Luo X, Lim CE, Li L, Wong WS. Hysteroscopic appearance of endometrial cavity after microwave endometrial ablation. J Minim Invasive Gynecol. 2010 Jan-Feb;17(1):30-6. doi: 10.1016/j.jmig.2009.09.012.

Reference Type BACKGROUND
PMID: 20129329 (View on PubMed)

Onoglu A, Taskin O, Inal M, Sadik S, Simsek M, Akar M, Kursun S, Mendilcioglu I, Postaci H, Ispahi C. Comparison of the long-term histopathologic and morphologic changes after endometrial rollerball ablation and resection: a prospective randomized trial. J Minim Invasive Gynecol. 2007 Jan-Feb;14(1):39-42. doi: 10.1016/j.jmig.2006.06.027.

Reference Type BACKGROUND
PMID: 17218227 (View on PubMed)

Taskin O, Onoglu A, Inal M, Turan E, Sadik S, Vardar E, Postaci H, Wheeler JM. Long-term histopathologic and morphologic changes after thermal endometrial ablation. J Am Assoc Gynecol Laparosc. 2002 May;9(2):186-90. doi: 10.1016/s1074-3804(05)60130-2.

Reference Type BACKGROUND
PMID: 11960046 (View on PubMed)

Leung PL, Tam WH, Yuen PM. Hysteroscopic appearance of the endometrial cavity following thermal balloon endometrial ablation. Fertil Steril. 2003 May;79(5):1226-8. doi: 10.1016/s0015-0282(02)04956-7.

Reference Type BACKGROUND
PMID: 12738523 (View on PubMed)

Colgan TJ, Shah R, Leyland N. Post-hysteroscopic ablation reaction: a histopathologic study of the effects of electrosurgical ablation. Int J Gynecol Pathol. 1999 Oct;18(4):325-31. doi: 10.1097/00004347-199910000-00006.

Reference Type BACKGROUND
PMID: 10542940 (View on PubMed)

Other Identifiers

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15-029

Identifier Type: -

Identifier Source: org_study_id

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