Tenaculum in Endometrial Sampling Procedure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-12-31

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.

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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).

Conditions

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Endometrium Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1(With Tenaculum)

This group consisted of the patients whose had been applied tenaculum at cervix during the endometrial sampling procedure

Group Type ACTIVE_COMPARATOR

Tenaculum

Intervention Type DEVICE

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.

Group 2 (Without Tenaculum)

This group consisted of the patients whose had been not applied tenaculum during the endometrial sampling procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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