Endometrial Biopsy Instrument Comparison Study

Oregon Health and Science University73 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Pain

Interventions

Pipelle de CornierDEVICE

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.

Explora curetteDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Oregon Health & Science University

Portland, Oregon, United States

Portland Veterans Affairs Medical Center

Portland, Oregon, United States

Outcomes

Primary Outcomes

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).

Time frame: 2 minutes after biopsy procedure

Secondary Outcomes

Sample Adequacy

adequacy of sample obtained for examination by a pathologist

Time frame: at time of biopsy

Data from ClinicalTrials.gov

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