Tenaculum in Endometrial Sampling Procedure

Biopsy Clinical Trial

— Tenaculum  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506778
• Other study ID #: CukurovaU
• Status: Completed
• Phase: N/A
• First received: January 2, 2012
• Last updated: January 9, 2012
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Most of gynecological office procedure such as endometrial sampling procedure, hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device, difficult intrauterine insemination or embryo transfer procedures often require the application of a single tooth tenaculum to the cervix for steady the cervix, straighten the cervicouterine angle and provide countertraction. However, grasping the cervix with a tenaculum can be a painful experience for the patient.A randomized controlled trial was conducted to evaluate using of tenaculum on pain perception of the patients and the procedure performance of the surgeons in endometrial sampling procedure(ESP) with pipelle.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 ß-HCG test.

Study Design

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

Related Conditions & MeSH terms

• Biopsy
• Endometrium

Intervention

Device:
• Tenaculum
Single tooth tenaculum are use to the cervix for steady the cervix, straighten the cervicouterine angle and provide countertraction. Most of gynecological office procedure such as endometrial sampling procedure, hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device, difficult intrauterine insemination or embryo transfer procedures often require the application of a tenaculum.

Locations

Country	Name	City	State
Turkey	Cukurova University Faculty of Medicine	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scala for patient's pain perception	VAS performed four times each patient.	5 second	No
Secondary	Likert scala for procedure performance	Likert scaled one times by the physician.	5 second	No
Secondary	Success rate as adequate sampling of endometrial tissue for histopathologic diagnosis.		5-10 day	No