Clinical trial NCT01506778: Tenaculum in Endometrial Sampling Procedure
Official title: Using a Tenaculum Which is Actually Necessary for Endometrial Sampling Procedure by Pipelle.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrium
Biopsy
Keywords: Endometrial Sampling Procedure
Likert Scala
Pipelle
Tenaculum
Visual Analog Pain Scala
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2012-01-10
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

Eligibility 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.

Primary outcomes:
measure: Visual Analog Scala for patient's pain perception
timeFrame: 5 second
Secondary outcomes:
measure: Likert scala for procedure performance
timeFrame: 5 second
measure: Success rate as adequate sampling of endometrial tissue for histopathologic diagnosis.
timeFrame: 5-10 day
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Faculty of Medicine
Study officials:
affiliation: Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
name: Ahmet Baris Guzel, Assist Prof Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Şahinbey Goverment Hospital
name: Aybala Kubat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
name: Ghanim Khatib, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
name: Fatma Tuncay Ozgunen, Prof Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
name: Ibrahim Ferhat Urunsak, Assist Prof Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
name: Umran Kucukgoz Gulec, Assist Prof Dr.
role: STUDY_DIRECTOR
References: