Biopsy Size and Pain Perception During Colposcopic Biopsy

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status: Completed

Conditions: Tenaculum; Pain Uterus

Treatments: Other: Tenaculum replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT03279666

2017/47

Details and patient eligibility

About

The investigators will investigate patients pain and biopsy size during colposcopic biopsy. The investigators will use tenaculum randomized patient with or without intracervical blockage.

Full description

The study was designed four arms. The investigators will perform colposcopy because of various causes. The first arm is used tenaculum and performed intracervical blockage. The second arm is not used tenaculum and performed intracervical blockage. The third arm is used tenaculum and not performed intracervical blockage. The fourth arm is not used tenaculum and not performed intracervical blockage and then we will study patients pain and biopsy size during colposcopic biopsy. Pain reduce and biopsy size are very important for patient and diagnose of the cervix cancer.

Enrollment: 236 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-80 year-old women who had colposcopic biopsy

Exclusion criteria

• Had orthopedical problems
• Analgesic allergy
• Have previous cone biopsy
• Analgesic use until six hours before colposcopy
• Advanced cervicovaginal atrophy
• Linear Visual Analog Score for pain is used

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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236 participants in 4 patient groups

tenaculum with intracervical blockage

Active Comparator group

Treatment:

Other: Tenaculum replacement

No tenaculum with intracercical blockage

No Intervention group

Tenaculum without intracervical blockage

Active Comparator group

Treatment:

Other: Tenaculum replacement

No Tenaculum without intracervical blockage

No Intervention group