Tenaculum in Endometrial Sampling Procedure (Tenaculum)

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

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.

Study Overview

• Status: Completed
• Conditions: Endometrium; Biopsy
• Intervention / Treatment: Device: Tenaculum

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 Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey, 01330
    • Cukurova University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Principal Investigator: Ahmet Baris Guzel, Assist Prof Dr., Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology; Principal Investigator: Aybala Kubat, MD, Şahinbey Goverment Hospital; Principal Investigator: Ghanim Khatib, MD, Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology; Principal Investigator: Fatma Tuncay Ozgunen, Prof Dr., Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology; Principal Investigator: Ibrahim Ferhat Urunsak, Assist Prof Dr., Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology; Study Director: Umran Kucukgoz Gulec, Assist Prof Dr., Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: January 2, 2012
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 10, 2012

Study Record Updates

• Last Update Posted (Estimate): January 10, 2012
• Last Update Submitted That Met QC Criteria: January 9, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Endometrial Sampling Procedure; Likert Scala; Pipelle; Tenaculum; Visual Analog Pain Scala
• Other Study ID Numbers: CukurovaU (Other Identifier: CukurovaU)