Tenaculum in Endometrial Sampling Procedure

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01506778

Acronym

Tenaculum

Enrollment

115

Registered

2012-01-10

Start date

2011-05-31

Completion date

2011-12-31

Last updated

2012-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biopsy, Endometrium

Keywords

Endometrial Sampling Procedure, Likert Scala, Pipelle, Tenaculum, Visual Analog Pain Scala

Brief 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.

Detailed 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).

Interventions

DEVICETenaculum

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026