Tenaculum in Endometrial Sampling Procedure

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Endometrium, Biopsy

Intervention / Treatment
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* Device: Tenaculum


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1(With Tenaculum)<br>This group consisted of the patients whose had been applied tenaculum at cervix during the endometrial sampling procedure | Device: Tenaculum<br>* 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.<br>|
| No Intervention: Group 2 (Without Tenaculum)<br>This group consisted of the patients whose had been not applied tenaculum during the endometrial sampling procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scala for patient's pain perception | VAS performed four times each patient. | 5 second | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert scala for procedure performance | Likert scaled one times by the physician. | 5 second | 
| Success rate as adequate sampling of endometrial tissue for histopathologic diagnosis. |  | 5-10 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial Sampling Procedure, Likert Scala, Pipelle, Tenaculum, Visual Analog Pain Scala