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OpenTrials
Completed

NCT Number: NCT01506778

Tenaculum in Endometrial Sampling Procedure

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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Key information

Conditions

Endometrium Biopsy

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University Faculty of Medicine

Adana, 01330, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tenaculum

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.

Primary outcomes

  1. Visual Analog Scala for patient's pain perception

    Time frame: 5 second

    VAS performed four times each patient.

Secondary outcomes

  1. Likert scala for procedure performance

    Time frame: 5 second

    Likert scaled one times by the physician.

  2. Success rate as adequate sampling of endometrial tissue for histopathologic diagnosis.

    Time frame: 5-10 day

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Acronym: Tenaculum

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 10, 2012
Registry last updated
Jan 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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