Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation

Menorrhagia Clinical Trial

Official title:

Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584088
• Other study ID #: 15-029
• Status: Completed
• Start date: October 11, 2016
• Est. completion date: November 2021

Study information

• Verified date: December 2022
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Menorrhagia

Intervention

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

Locations

Country	Name	City	State
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Obstet Gynecol. 2008 Aug;112(2 Pt 1):381. — View Citation

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. Erratum In: Obstet Gynecol. 2010 Mar;115(3):663. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometrial thickness (measured using a scale)		2 months