A Prospective Study of Diagnostic Accuracy of Ultrasound

NCT03120078 | Terminated

• 1 other identifier: E17057
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Prospectively-Patients undergoing a hysterectomy for abnormal uterine bleeding (AUB) or pelvic pain will be enrolled in the study, will get pelvic ultrasound at the ultrasound clinic. An ultrasound will be obtained as part of the required clinical assessment before the patient undergoes a hysterectomy. The ultrasound images will be reviewed using Viewpoint reporting system-various sonographic features of adenomyosis will be reported detailed, including pelvic pathology, pelvic congestion syndrome etc. The histopathological examination will be done by assigned pathologist for accurate mapping/localizing the adenomyosis (appropriate section of uterus to defining localized versus generalized adenomyosis) on all patients diagnosed with adenomyosis on ultrasound. The ultrasound will be correlated with histopathology(which is the gold standard for diagnosis of adenomyosis). Scoring system for adenomyosis based on various sonographic features/clinical symptoms and their confirmation with histopathology will be developed.

Conditions

Adenomyosis

Keywords

Ultrasound

Outcome Measures

Primary Outcomes (1)

• Develop a scoring system for adenomyosis based on various sonographic features and clinical symptoms.

  Sonographic features

  Duration of Study

Secondary Outcomes (3)

• Review the diagnostic accuracy of ultrasound with adenomyosis.

  Duration of study

• Prevalence of coexisting pathology.

  Duration of Study

• Menstrual bleeding questionnaire

  Duration of Study

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients undergoing hysterectomy for with AUB or pelvic pain will be enrolled in the study.

You may qualify if:

• Women
• years or older but 60 years or less.
• Undergoing hysterectomy for AUB or pelvic pain

You may not qualify if:

• known cause of AUB or pelvic pain

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

Texas Tech University Health Science Center

El Paso, Texas, 79905, United States

Location

Related Publications (20)

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  PMID: 12751776 BACKGROUND

• Azziz R. Adenomyosis: current perspectives. Obstet Gynecol Clin North Am. 1989 Mar;16(1):221-35.

  PMID: 2664619 BACKGROUND

• Vercellini P, Ragni G, Trespidi L, Oldani S, Panazza S, Crosignani PG. Adenomyosis: a deja vu? Obstet Gynecol Surv. 1993 Dec;48(12):789-94.

  PMID: 8309661 BACKGROUND

• Farquhar C, Brosens I. Medical and surgical management of adenomyosis. Best Pract Res Clin Obstet Gynaecol. 2006 Aug;20(4):603-16. doi: 10.1016/j.bpobgyn.2006.01.012. Epub 2006 Mar 24.

  PMID: 16563872 BACKGROUND

• Bragheto AM, Caserta N, Bahamondes L, Petta CA. Effectiveness of the levonorgestrel-releasing intrauterine system in the treatment of adenomyosis diagnosed and monitored by magnetic resonance imaging. Contraception. 2007 Sep;76(3):195-9. doi: 10.1016/j.contraception.2007.05.091. Epub 2007 Jul 27.

  PMID: 17707716 BACKGROUND

• Garcia L, Isaacson K. Adenomyosis: review of the literature. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):428-37. doi: 10.1016/j.jmig.2011.04.004. Epub 2011 May 31.

  PMID: 21622029 BACKGROUND

• Dong X, Yang Z. High-intensity focused ultrasound ablation of uterine localized adenomyosis. Curr Opin Obstet Gynecol. 2010 Aug;22(4):326-30. doi: 10.1097/GCO.0b013e32833bea2e.

  PMID: 20610999 BACKGROUND

• Horng HC, Chen CH, Chen CY, Tsui KH, Liu WM, Wang PH, Chang WH, Huang BS, Sun HD, Chang TC, Chang WC, Yen MS. Uterine-sparing surgery for adenomyosis and/or adenomyoma. Taiwan J Obstet Gynecol. 2014 Mar;53(1):3-7. doi: 10.1016/j.tjog.2014.01.001.

  PMID: 24767637 BACKGROUND

• Fukunishi H, Funaki K, Sawada K, Yamaguchi K, Maeda T, Kaji Y. Early results of magnetic resonance-guided focused ultrasound surgery of adenomyosis: analysis of 20 cases. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):571-9. doi: 10.1016/j.jmig.2008.06.010. Epub 2008 Jul 26.

  PMID: 18657480 BACKGROUND

• Kim MD, Kim S, Kim NK, Lee MH, Ahn EH, Kim HJ, Cho JH, Cha SH. Long-term results of uterine artery embolization for symptomatic adenomyosis. AJR Am J Roentgenol. 2007 Jan;188(1):176-81. doi: 10.2214/AJR.05.1613.

  PMID: 17179361 BACKGROUND

• Kitamura Y, Allison SJ, Jha RC, Spies JB, Flick PA, Ascher SM. MRI of adenomyosis: changes with uterine artery embolization. AJR Am J Roentgenol. 2006 Mar;186(3):855-64. doi: 10.2214/AJR.04.1661.

  PMID: 16498121 BACKGROUND

• Pelage JP, Jacob D, Fazel A, Namur J, Laurent A, Rymer R, Le Dref O. Midterm results of uterine artery embolization for symptomatic adenomyosis: initial experience. Radiology. 2005 Mar;234(3):948-53. doi: 10.1148/radiol.2343031697. Epub 2005 Jan 28.

  PMID: 15681687 BACKGROUND

• Wang PH, Liu WM, Fuh JL, Cheng MH, Chao HT. Comparison of surgery alone and combined surgical-medical treatment in the management of symptomatic uterine adenomyoma. Fertil Steril. 2009 Sep;92(3):876-885. doi: 10.1016/j.fertnstert.2008.07.1744. Epub 2008 Sep 6.

  PMID: 18774566 BACKGROUND

• Wood C. Surgical and medical treatment of adenomyosis. Hum Reprod Update. 1998 Jul-Aug;4(4):323-36. doi: 10.1093/humupd/4.4.323.

  PMID: 9825848 BACKGROUND

• Bazot M, Cortez A, Darai E, Rouger J, Chopier J, Antoine JM, Uzan S. Ultrasonography compared with magnetic resonance imaging for the diagnosis of adenomyosis: correlation with histopathology. Hum Reprod. 2001 Nov;16(11):2427-33. doi: 10.1093/humrep/16.11.2427.

  PMID: 11679533 BACKGROUND

• Gatti GL, Michalek H. Investigations on rapeseed oil toxicology. Arzneimittelforschung. 1975 Oct;25(10):1639-42.

  PMID: 1243051 BACKGROUND

• Dueholm M, Lundorf E, Hansen ES, Sorensen JS, Ledertoug S, Olesen F. Magnetic resonance imaging and transvaginal ultrasonography for the diagnosis of adenomyosis. Fertil Steril. 2001 Sep;76(3):588-94. doi: 10.1016/s0015-0282(01)01962-8.

  PMID: 11532486 BACKGROUND

• Kepkep K, Tuncay YA, Goynumer G, Tutal E. Transvaginal sonography in the diagnosis of adenomyosis: which findings are most accurate? Ultrasound Obstet Gynecol. 2007 Sep;30(3):341-5. doi: 10.1002/uog.3985.

  PMID: 17659649 BACKGROUND

• Meredith SM, Sanchez-Ramos L, Kaunitz AM. Diagnostic accuracy of transvaginal sonography for the diagnosis of adenomyosis: systematic review and metaanalysis. Am J Obstet Gynecol. 2009 Jul;201(1):107.e1-6. doi: 10.1016/j.ajog.2009.03.021. Epub 2009 Apr 26.

  PMID: 19398089 BACKGROUND

• Gordts S, Brosens JJ, Fusi L, Benagiano G, Brosens I. Uterine adenomyosis: a need for uniform terminology and consensus classification. Reprod Biomed Online. 2008 Aug;17(2):244-8. doi: 10.1016/s1472-6483(10)60201-5.

  PMID: 18681999 BACKGROUND

MeSH Terms

Conditions

Adenomyosis

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Sushila Arya, MD

  Texas Tech University Health Sciences Center, El Paso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 19, 2017
• Study Start: June 1, 2017
• Primary Completion: December 14, 2017
• Study Completion: December 14, 2017
• Last Updated: April 26, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)