Tenaculum in Endometrial Sampling Procedure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ümran Küçükgöz Güleç, Cukurova University
ClinicalTrials.gov Identifier:
NCT01506778
First received: January 2, 2012
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Endometrium
Biopsy
Device: Tenaculum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Using a Tenaculum Which is Actually Necessary for Endometrial Sampling Procedure by Pipelle.

Further study details as provided by Cukurova University:

Primary Outcome Measures:
  • Visual Analog Scala for patient's pain perception [ Time Frame: 5 second ] [ Designated as safety issue: No ]
    VAS performed four times each patient.


Secondary Outcome Measures:
  • Likert scala for procedure performance [ Time Frame: 5 second ] [ Designated as safety issue: No ]
    Likert scaled one times by the physician.

  • Success rate as adequate sampling of endometrial tissue for histopathologic diagnosis. [ Time Frame: 5-10 day ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506778

Locations
Turkey
Cukurova University Faculty of Medicine
Adana, Turkey, 01330
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Ümran Küçükgöz Güleç, Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology, Cukurova University
ClinicalTrials.gov Identifier: NCT01506778     History of Changes
Other Study ID Numbers: CukurovaU
Study First Received: January 2, 2012
Last Updated: January 9, 2012
Health Authority: Turkey: Ethics Committee

Keywords provided by Cukurova University:
Endometrial Sampling Procedure
Likert Scala
Pipelle
Tenaculum
Visual Analog Pain Scala

ClinicalTrials.gov processed this record on August 20, 2014