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

January 2, 2012
January 9, 2012
May 2011
December 2011   (final data collection date for primary outcome measure)
Visual Analog Scala for patient's pain perception [ Time Frame: 5 second ] [ Designated as safety issue: No ]
VAS performed four times each patient.
Same as current
Complete list of historical versions of study NCT01506778 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Tenaculum in Endometrial Sampling Procedure
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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
  • Endometrium
  • Biopsy
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.
  • Active Comparator: Group 1(With Tenaculum)
    This group consisted of the patients whose had been applied tenaculum at cervix during the endometrial sampling procedure
    Intervention: Device: Tenaculum
  • No Intervention: Group 2 (Without Tenaculum)
    This group consisted of the patients whose had been not applied tenaculum during the endometrial sampling procedure.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01506778
CukurovaU
No
Ümran Küçükgöz Güleç, Cukurova University
Cukurova University
Not Provided
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
Cukurova University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP