Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy

Uterine Fibroids Clinical Trial

Official title:

Office Based Evaluation of Patients Presenting With Abnormal Uterine Bleeding and/or Uterine Fibroids With Concurrent Office Hysteroscopy and Endometrial Biopsy; Does the Order Matter?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472184
• Other study ID #: Pro00022436
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: March 2017

Study information

• Verified date: December 2016
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will look at the optimal order in which to perform concurrent office hysteroscopy and endometrial biopsy in female patients who present for evaluation of abnormal uterine bleeding at a fibroid and endometriosis treatment center.

Description:

This will be a prospective single blinded randomized control trial to determine whether the order of performance of office hysteroscopy (OH) and endometrial biopsy (EMB) during the same office evaluation for abnormal uterine bleeding affects the patient's pain perception. We also intend to investigate whether the order of the procedures affects the adequacy of the endometrial sample, duration of the procedure, and optimal visualization of the uterine cavity. We hypothesize that performing EMB prior to OH will result in higher patient pain scores.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• All consecutive female patients ages 18-70 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 with ability to provide written informed consent.

Exclusion Criteria:

• Patients unable to provide informed consent

• 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

Related Conditions & MeSH terms

• Hemorrhage
• Leiomyoma
• Uterine Fibroids
• Uterine Hemorrhage
• Vaginal Bleeding

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	University of South Florida College of Medicien Department of Obstetrics and Gynecology	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (5)

American College of Obstetricians and Gynecologists. Technology assessment No. 7: Hysteroscopy. Obstet Gynecol. 2011 Jun;117(6):1486-91. doi: 10.1097/AOG.0b013e3182238c7d. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient pain scores	After the procedures are performed, the patient will be asked to describe their pain perception based on Visual analogue scale (VAS) from 0-10	Immediately following procedures
Secondary	Adequacy of endometrial sample	The adequacy of the endometrial sample will be determined from the pathology report.	Within 2 weeks following endometrial biopsy
Secondary	Duration of procedure	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.	Immediately following procedure
Secondary	Visualization of endometrial cavity	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.	During procedure