Biopsy Clinical Trial
— TenaculumOfficial title:
Using a Tenaculum Which is Actually Necessary for Endometrial Sampling Procedure by Pipelle.
Verified date | January 2012 |
Source | Cukurova University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 115 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
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 ß-HCG test. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Turkey | Cukurova University Faculty of Medicine | Adana |
Lead Sponsor | Collaborator |
---|---|
Cukurova University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scala for patient's pain perception | VAS performed four times each patient. | 5 second | No |
Secondary | Likert scala for procedure performance | Likert scaled one times by the physician. | 5 second | No |
Secondary | Success rate as adequate sampling of endometrial tissue for histopathologic diagnosis. | 5-10 day | No |
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