Using a Tenaculum Which is Actually Necessary for Endometrial Sampling Procedure by Pipelle.
18 Years
80 Years
Female
Endometrium, Biopsy
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
clinic.
- 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:
Interventional
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:
No
Principal Investigator
Ahmet Baris Guzel, Assist Prof Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
Authority:
Turkey: Ethics Committee
Study ID:
CukurovaU
NCT ID:
NCT01506778
Start Date:
May 2011
Completion Date:
December 2011
Related Keywords:
- Endometrium
- Biopsy
- Endometrial Sampling Procedure
- Likert Scala
- Pipelle
- Tenaculum
- Visual Analog Pain Scala
- Adenoma
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