Endometrial Biopsy Instrument Comparison Study

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613925
• Other study ID #: OHSU RES 4145
• Status: Completed
• Phase: N/A
• First received: January 31, 2008
• Last updated: April 7, 2014
• Start date: January 2008
• Est. completion date: January 2011

Study information

• Verified date: April 2014
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: January 2011
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Pipelle 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.
• Explora 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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon
United States	Portland Veterans Affairs Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):636-41. doi: 10.1097/AOG.0b013e31820ad45b. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	2 minutes after biopsy procedure	No
Secondary	Sample Adequacy	adequacy of sample obtained for examination by a pathologist	at time of biopsy	No