Hemostatic Procedure After Biopsy of the Cervix

Zydolab - Institute of Cytology and Immune Cytochemistry

Status: Completed

Conditions: Uterine Cervical Dysplasia

Treatments: Procedure: Monsel´s Paste; Other: Wait and see

Study type: Interventional

Funder types: Other

Identifiers

NCT02486471

COLPO-1

Details and patient eligibility

About

Cytological abnormalities of the Cervix uteri need to be clarified by colposcopy biopsy. To avoid bleeding after biopsy, monsel´s paste is a common used Agent. In a randomized clinical Trial the use of monsel´s paste after biopsy will be compared to no Intervention. The Primary outcome of the study is blood loss, secondary outcomes are pain, satisfaction of the patient and influence of Independent factors such as Age and Body mass index.

Enrollment: 166 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• abnormal pap smear
• first colposcopy ever

Exclusion criteria

• pregnancy
• bleeding disorder
• the use of blood thinner
• language barrier
• unwillingness to participate

Trial design

166 participants in 2 patient groups

Observational approach

Other group

Description:

Wait and see

Treatment:

Other: Wait and see

Use of Monsel´s Paste

Active Comparator group

Description:

cervical coagulation using a hemostatic agents, ie monsel´s paste

Treatment:

Procedure: Monsel´s Paste