Tenaculum in Endometrial Sampling Procedure

Not Applicable

Completed

• Conditions: Biopsy; Endometrium
• Interventions: Device: Tenaculum

• Registration Number: NCT01506778
• Lead Sponsor: Cukurova University

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).

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Study First Submitted: 2012-01-02
• Study First Submitted QC: 2012-01-09
• Last Update Submitted: 2012-01-09
• Study First Posted: 2012-01-10
• Last Update Posted: 2012-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 115

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1(With Tenaculum)	Tenaculum	This group consisted of the patients whose had been applied tenaculum at cervix during the endometrial sampling procedure

Primary Outcome Measures

Name	Time	Method
Visual Analog Scala for patient's pain perception	5 second	VAS performed four times each patient.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cukurova University Faculty of Medicine; 🇹🇷 Adana, Turkey