Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy

NCT02472184 | Completed

• 1 other identifier: Pro00022436
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Fibroids; Vaginal Bleeding

Keywords

Office hysteroscopy; Endometrial biopsy; Abnormal uterine bleeding; Uterine fibroids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Adequacy of endometrial sample

  Within 2 weeks following endometrial biopsy

• Duration of procedure

  Immediately following procedure

• Visualization of endometrial cavity

  During procedure

Study Arms (2)

Office Hysteroscopy

ACTIVE COMPARATOR

Group of patients in which office hysteroscopy will be performed prior to endometrial biopsy

Procedure: Office hysteroscopy; Procedure: Endometrial biopsy

Endometrial biopsy

ACTIVE COMPARATOR

Group of patients in which endometrial biopsy will be performed prior to office hysteroscopy

Procedure: Office hysteroscopy; Procedure: Endometrial biopsy

Interventions

Office hysteroscopy PROCEDURE

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; Office Hysteroscopy

Endometrial biopsy PROCEDURE

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; Office Hysteroscopy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida College of Medicien Department of Obstetrics and Gynecology

Tampa, Florida, 33606, United States

Location

Related Publications (6)

• 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.

  PMID: 22914421 BACKGROUND

• Technology assessment No. 7: Hysteroscopy. Obstet Gynecol. 2011 Jun;117(6):1486-1491. doi: 10.1097/AOG.0b013e3182238c7d.

  PMID: 21606772 BACKGROUND

• 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.

  PMID: 16169403 BACKGROUND

• 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.

  PMID: 12350192 BACKGROUND

• 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.

  PMID: 18366496 BACKGROUND

• 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.

  PMID: 28796688 DERIVED

MeSH Terms

Conditions

Leiomyoma; Uterine Hemorrhage; Metrorrhagia

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anthony Imudia, MD

  University of South Florida College of Medicine Department of Infertility and Reproductive Endocrinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 15, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 26, 2018

Record last verified: 2016-12

Locations

US (1)