Tenaculum in Endometrial Sampling Procedure

Çukurova University

Status: Completed

Conditions: Endometrium; Biopsy

Treatments: Device: Tenaculum

Study type: Interventional

Funder types: Other

Identifiers

NCT01506778

CukurovaU

Details and patient eligibility

About

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.

Full 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).

Enrollment: 115 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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115 participants in 2 patient groups

Group 1(With Tenaculum)

Active Comparator group

Description:

This group consisted of the patients whose had been applied tenaculum at cervix during the endometrial sampling procedure

Treatment:

Device: Tenaculum

Group 2 (Without Tenaculum)

No Intervention group

Description:

This group consisted of the patients whose had been not applied tenaculum during the endometrial sampling procedure.