Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy

Not Applicable

Completed

• Conditions: Uterine Fibroids; Vaginal Bleeding
• Interventions: Procedure: Office hysteroscopy; Procedure: Endometrial biopsy

• Registration Number: NCT02472184
• Lead Sponsor: University of South Florida

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-15
• Study Start: 2015-10
• Status Verified: 2016-12
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Office Hysteroscopy	Office hysteroscopy	Group of patients in which office hysteroscopy will be performed prior to endometrial biopsy
Office Hysteroscopy	Endometrial biopsy	Group of patients in which office hysteroscopy will be performed prior to endometrial biopsy
Endometrial biopsy	Endometrial biopsy	Group of patients in which endometrial biopsy will be performed prior to office hysteroscopy
Endometrial biopsy	Office hysteroscopy	Group of patients in which endometrial biopsy will be performed prior to office hysteroscopy

Primary Outcome Measures

Name	Time	Method
Patient pain scores	Immediately following procedures	After the procedures are performed, the patient will be asked to describe their pain perception based on Visual analogue scale (VAS) from 0-10

Secondary Outcome Measures

Name	Time	Method
Visualization of endometrial cavity	During procedure	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.
Adequacy of endometrial sample	Within 2 weeks following endometrial biopsy	The adequacy of the endometrial sample will be determined from the pathology report.
Duration of procedure	Immediately following 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.

Trial Locations

Locations (1)

University of South Florida College of Medicien Department of Obstetrics and Gynecology; 🇺🇸 Tampa, Florida, United States