Endometrial Biopsy Instrument Comparison Study

Study Overview
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Brief Summary
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The purpose of this study is to determine the level of pain women experience during an endometrial biopsy and the effect that the biopsy tool might have on that pain. The investigators will also evaluate the adequacy of the sample each endometrial biopsy tool collects.

Detailed Description
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Is there a difference in pain perceived by patients undergoing endometrial biopsy via the Pipelle or Explora curette? Currently, the instrument selected for endometrial biopsy is solely dependent on provider preference. This study aims to elucidate advantages and/or disadvantages of the Pipelle versus the Explora curette in terms of pain perceived by the patient, adequacy of sample, and provider ease of use to better aid in the selection of the appropriate device.

Official Title
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Comparison of Pain Experienced by Patients Undergoing Endometrial Biopsy by Pipelle and Explora Curette

Conditions
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Pain

Intervention / Treatment
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* Device: Pipelle de Cornier
* Device: Explora curette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women ages 18 and over who present to the Oregon Health and Science University Center for Women's Health and the Portland Veteran's Affairs Medical Center with an indication for endometrial biopsy, are literate in English or Spanish, who are willing to participate in the study. Exclusion Criteria: Pregnancy, known or suspected Known cervical stenosis History of Mullerian tract anomalies History of uterine or cervical surgery Pelvic inflammatory disease (current or within the past 3 months) Sexually transmitted diseases (current) Puerperal or post abortion sepsis (current or within the past 3 months) Purulent cervicitis (current) Known clotting disorder Known uterine anomalies or fibroids distorting the cavity in a way incompatible with office endometrial biopsy Allergy to any component of the Pipelle or Explora curette Patients who are premedicated with analgesics or misoprostol Patients who require mechanical cervical dilation or receive paracervical block

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pipelle Group<br>Women were randomized to have an endometrial biopsy collected using Pipelle de Cornier instrument. | Device: Pipelle de Cornier<br>* A flexible suction cannula 23.5 cm in length with an inner diameter of 2.6 mm and an outer diameter of 3.1 mm. It has a 2.4mm diameter opening on the distal end, on one side of the cannula. It is a disposable polypropylene sheath with an inner plunger and is used for blind endometrial biopsy.<br>* Other names: Pipelle;|
| Active Comparator: Explora group<br>Women were randomized to have an endometrial biopsy collected using Explora curette instrument. | Device: Explora curette<br>* The curette has an outer diameter of 3.0 mm and is slightly more rigid. This cannula has a sharp Randall-type cutting edge on the distal end, on one side of the cannula.<br>* Other names: Explora;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Pipelle and Explora Curette Groups With Respect to Patient Perception of Pain Associated With the Procedure as Rated by a 100mm Visual Analog Scale (VAS). | The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain in My Life (furthest point to the right). | 2 minutes after biopsy procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sample Adequacy | adequacy of sample obtained for examination by a pathologist | at time of biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrial biopsy, pain management