Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pipelle Group | Active Comparator | Women were randomized to have an endometrial biopsy collected using Pipelle de Cornier instrument. |
|
| Explora group | Active Comparator | Women were randomized to have an endometrial biopsy collected using Explora curette instrument. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pipelle de Cornier | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sample Adequacy | adequacy of sample obtained for examination by a pathologist | at time of biopsy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alison Edelman, MD, MPH | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States | ||
| Portland Veterans Affairs Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21343767 | Result | Leclair CM, Zia JK, Doom CM, Morgan TK, Edelman AB. Pain experienced using two different methods of endometrial biopsy: a randomized controlled trial. Obstet Gynecol. 2011 Mar;117(3):636-641. doi: 10.1097/AOG.0b013e31820ad45b. |
Not provided
Not provided
73 women enrolled; 3 excluded (1 cervical stenosis;1 had to have another procedure; 1 biopsy not indicated)
January 2008 to August 2009; Academic outpatient OB/GYN clinic
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pipelle Group | Women were randomized to the Pipelle for endometrial biopsy |
| FG001 | Explora Group | Women were randomized to the Explora device for endometrial biopsy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pipelle Group | Women were randomized to the Pipelle for endometrial biopsy |
| BG001 | Explora Group | Women were randomized to the Explora device for endometrial biopsy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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) | Posted | Mean | Standard Deviation | mm | 2 minutes after biopsy procedure |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pipelle Group | Women were randomized to the Pipelle for endometrial biopsy |
Not provided
Not provided
Providers not blinded
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Edelman, Associate Professor | Oregon health & Science University | 503-418-2585 | edelmana@ohsu.edu |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Explora curette | Device | 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. |
|
|
| Portland |
| Oregon |
| 97239 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Explora Group | Women were randomized to the Explora device for endometrial biopsy |
|
|
| Secondary | Sample Adequacy | adequacy of sample obtained for examination by a pathologist | Posted | Number | percentage of participants | at time of biopsy |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Explora Group | Women were randomized to the Explora device for endometrial biopsy | 0 | 33 | 0 | 33 |
Not provided
Not provided
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |