Comparison of Pain Experienced by Patients Undergoing Endometrial Biopsy by Pipelle and Explora Curette
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 4
- 主要终点
- 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).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
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).
时间窗: 2 minutes after biopsy procedure
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).
次要结局
- Sample Adequacy(at time of biopsy)
研究者
Alison Edelman
MD MPH
Oregon Health and Science University