Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy
NCT ID: NCT02472184
Last Updated: 2018-09-26
Study Results
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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COMPLETED
NA
78 participants
INTERVENTIONAL
2015-10-31
2017-03-31
Brief Summary
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Detailed Description
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Included patients will be all consecutive female patients ages 18-70 presenting to the University of South Florida Center for Endometriosis and Fibroid Treatment (CFERT) for evaluation of abnormal uterine bleeding or uterine fibroids.
Patients will be randomly assigned to have either OH followed by EMB or EMB followed by OH as part of their clinical assessment of AUB/uterine fibroid based on clinical indication. The patients will be informed about the two indicated procedures by their clinical provider but will be blinded to the order of performance. The healthcare provider/investigator will be aware of the order in which the procedures are assigned and to be performed. Patients will be consented to participate in the study prior to the procedure by the study team on the day the indicated procedures are scheduled in CFERT. The healthcare provider performing the procedure will open an unlabeled envelope, within which there will be a piece of paper indicating which procedure is to be performed first. This will then be recorded in the study log. The study log will include enrolled patients, assigned study number which will range from 001 to the minimum number of patients required for the study as indicated by sample size calculation.
At the end of the procedures, patient will be asked to describe their pain perception based on Visual analogue scale (VAS) from 0-10. The adequacy of the endometrial sample will be determined from the pathology report. The duration of the entire procedures (min) will be timed using a stopwatch from the time of insertion of the hysteroscope/Pipelle catheter in the external cervical canal to removal of the instruments. A panoramic picture of the endometrial cavity will be taken and will be given to a blinded independent reviewer to determine the adequacy of visualization based on 3 point scoring system (fair, good and excellent). Fair visualization will be defined as no tubal ostia visualized; good will be defined as both tubal ostia identified but only able to visualize 180 degrees of panorama; excellent visualization will be defined as visualizing bilateral tubal ostia and having a clear image of the uterine cavity in 360 degrees of panorama.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Office Hysteroscopy
Group of patients in which office hysteroscopy will be performed prior to endometrial biopsy
Office hysteroscopy
Office hysteroscopy is a procedure performed in the office in which a flexible hysteroscope is inserted into the uterine cavity. The patient is positioned in a dorsal lithotomy position and teh cervix is visualized with a speculum. Normal saline is used to distend the cavity, and the hysteroscope is used to visualize any abnormalities within the cavity.
Endometrial biopsy
An endometrial biopsy is a procedure in which a pipelle instrument is inserted into the uterine cavity and suction from the pipelle is used to obtain endometrial tissue. This is performed with the patient in the dorsal lithotomy position and a speculum is used to visualize the cervix.
Endometrial biopsy
Group of patients in which endometrial biopsy will be performed prior to office hysteroscopy
Office hysteroscopy
Office hysteroscopy is a procedure performed in the office in which a flexible hysteroscope is inserted into the uterine cavity. The patient is positioned in a dorsal lithotomy position and teh cervix is visualized with a speculum. Normal saline is used to distend the cavity, and the hysteroscope is used to visualize any abnormalities within the cavity.
Endometrial biopsy
An endometrial biopsy is a procedure in which a pipelle instrument is inserted into the uterine cavity and suction from the pipelle is used to obtain endometrial tissue. This is performed with the patient in the dorsal lithotomy position and a speculum is used to visualize the cervix.
Interventions
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Office hysteroscopy
Office hysteroscopy is a procedure performed in the office in which a flexible hysteroscope is inserted into the uterine cavity. The patient is positioned in a dorsal lithotomy position and teh cervix is visualized with a speculum. Normal saline is used to distend the cavity, and the hysteroscope is used to visualize any abnormalities within the cavity.
Endometrial biopsy
An endometrial biopsy is a procedure in which a pipelle instrument is inserted into the uterine cavity and suction from the pipelle is used to obtain endometrial tissue. This is performed with the patient in the dorsal lithotomy position and a speculum is used to visualize the cervix.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients presenting to the Center for Fibroid and Endometriosis Research and Treatment for medically indicated office hysteroscopy and endometrial biopsy for evaluation of abnormal uterine bleeding and or uterine fibroids are not deemed clinically indicated based on the assessment of their clinical provider.
* Patients in which office hysteroscopy or endometrial biopsy is unsuccessful due to patient discomfort, known cervical stenosis, or poor visualization of the cervix
18 Years
70 Years
FEMALE
Yes
Sponsors
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University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Anthony Imudia, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida College of Medicine Department of Infertility and Reproductive Endocrinology
Locations
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University of South Florida College of Medicien Department of Obstetrics and Gynecology
Tampa, Florida, United States
Countries
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References
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Committee on Practice Bulletins-Gynecology. Practice bulletin no. 128: diagnosis of abnormal uterine bleeding in reproductive-aged women. Obstet Gynecol. 2012 Jul;120(1):197-206. doi: 10.1097/AOG.0b013e318262e320. No abstract available.
Technology assessment No. 7: Hysteroscopy. Obstet Gynecol. 2011 Jun;117(6):1486-1491. doi: 10.1097/AOG.0b013e3182238c7d.
Kelekci S, Kaya E, Alan M, Alan Y, Bilge U, Mollamahmutoglu L. Comparison of transvaginal sonography, saline infusion sonography, and office hysteroscopy in reproductive-aged women with or without abnormal uterine bleeding. Fertil Steril. 2005 Sep;84(3):682-6. doi: 10.1016/j.fertnstert.2005.03.036.
Clark TJ, Voit D, Gupta JK, Hyde C, Song F, Khan KS. Accuracy of hysteroscopy in the diagnosis of endometrial cancer and hyperplasia: a systematic quantitative review. JAMA. 2002 Oct 2;288(13):1610-21. doi: 10.1001/jama.288.13.1610.
Ghaly S, de Abreu Lourenco R, Abbott JA. Audit of endometrial biopsy at outpatient hysteroscopy. Aust N Z J Obstet Gynaecol. 2008 Apr;48(2):202-6. doi: 10.1111/j.1479-828X.2008.00834.x.
Sarkar P, Mikhail E, Schickler R, Plosker S, Imudia AN. Optimal Order of Successive Office Hysteroscopy and Endometrial Biopsy for the Evaluation of Abnormal Uterine Bleeding: A Randomized Controlled Trial. Obstet Gynecol. 2017 Sep;130(3):565-572. doi: 10.1097/AOG.0000000000002202.
Other Identifiers
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Pro00022436
Identifier Type: -
Identifier Source: org_study_id
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