Pain
Conditions
Keywords
endometrial biopsy, pain management
Brief summary
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
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.
Interventions
DEVICEPipelle de Cornier
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.
DEVICEExplora curette
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.
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sample Adequacy | at time of biopsy | adequacy of sample obtained for examination by a pathologist |
Countries
United States
Participant flow
Recruitment details
January 2008 to August 2009; Academic outpatient OB/GYN clinic
Pre-assignment details
73 women enrolled; 3 excluded (1 cervical stenosis;1 had to have another procedure; 1 biopsy not indicated)
Participants by arm
| Arm | Count |
|---|---|
| Pipelle Group Women were randomized to the Pipelle for endometrial biopsy | 37 |
| Explora Group Women were randomized to the Explora device for endometrial biopsy | 33 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | 1 did not tolerate outpatient biopsy | 0 | 1 |
Baseline characteristics
| Characteristic | Explora Group | Pipelle Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 37 Participants | 70 Participants |
| Age, Continuous | 46.1 years STANDARD_DEVIATION 7.7 | 45.2 years STANDARD_DEVIATION 7.3 | 45.7 years STANDARD_DEVIATION 7.4 |
| Region of Enrollment United States | 33 participants | 37 participants | 70 participants |
| Sex: Female, Male Female | 33 Participants | 37 Participants | 70 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 33 |
| serious Total, serious adverse events | 0 / 37 | 0 / 33 |
Outcome results
Primary
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
Population: To demonstrate a 20 mm difference on the 100 mm visual analog scale, sample size of 35 women in each group (80% power, 0.05 alpha, SD 30mm)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pipelle Group | 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). | 62.1 mm | Standard Deviation 24.1 |
| Explora Group | 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). | 69.1 mm | Standard Deviation 28.8 |
Secondary
Sample Adequacy
adequacy of sample obtained for examination by a pathologist
Time frame: at time of biopsy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pipelle Group | Sample Adequacy | 91.2 percentage of participants |
| Explora Group | Sample Adequacy | 98.6 percentage of participants |