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Using a Tenaculum Which is Actually Necessary for Endometrial Sampling Procedure by Pipelle.

18 Years
80 Years
Not Enrolling
Endometrium, Biopsy

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Trial Information

Using a Tenaculum Which is Actually Necessary for Endometrial Sampling Procedure by Pipelle.

One hundred fifteen patients included for assessing pain perception and procedure
performance during endometrial with pipelle. Patients were randomly assigned to one of two
groups as Group 1( with tenaculum) and Group 2 (without tenaculum).

Inclusion Criteria:

- 18-80 years old

- The women has required endometrial sampling procedure in gynecology outpatients

- Who are capable understand the spoken words and describe the pain.

Exclusion Criteria:

- Stenotic cervical canal

- They had acute cervicitis

- Intense anxiety

- Need for coincident endocervical curettage

- Need for general anesthesia or local anesthetics

- The use of analgesic drug pre-procedure

- Known history of malignancy

- Uterine anomalies or leiomyomas that distort the cervical canal and cavity

- A history of failed office endometrial sampling

- Positive β-HCG test.

Type of Study:


Study Design:

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

Outcome Measure:

Visual Analog Scala for patient's pain perception

Outcome Description:

VAS performed four times each patient.

Outcome Time Frame:

5 second

Safety Issue:


Principal Investigator

Ahmet Baris Guzel, Assist Prof Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology


Turkey: Ethics Committee

Study ID:




Start Date:

May 2011

Completion Date:

December 2011

Related Keywords:

  • Endometrium
  • Biopsy
  • Endometrial Sampling Procedure
  • Likert Scala
  • Pipelle
  • Tenaculum
  • Visual Analog Pain Scala
  • Adenoma