Know Cancer

or
forgot password

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


N/A
18 Years
85 Years
Not Enrolling
Female
Pain

Thank you

Trial Information

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


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.


Inclusion Criteria:



- Women ages 18 and over who present to the OHSU 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Compare Pipelle and Explora curette groups with respect to patient perception of pain associated with the procedure as rated by a 10 cm visual analog scale.

Outcome Time Frame:

Two Years

Safety Issue:

No

Principal Investigator

Alison Edelman, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Science University

Authority:

United States: Institutional Review Board

Study ID:

OHSU RES 4145

NCT ID:

NCT00613925

Start Date:

January 2009

Completion Date:

December 2010

Related Keywords:

  • Pain
  • endometrial biopsy
  • pain management
  • Adenoma

Name

Location

Oregon Health & Science UniversityPortland, Oregon  97201
Portland Veterans Affairs Medical CenterPortland, Oregon  97239