NCT02486471

Hemostatic Procedure After Biopsy of the Cervix

Is a Hemostatic Procedure Required After Biopsy of the Cervix Uteri in Women Undergoing Colposcopy for Cervical Dysplasia? A Multicenter Randomized Non-inferiority Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Uterine Cervical Dysplasia

Interventions

Type	Name	Description
PROCEDURE	Monsel´s Paste	surgical method to stop bleeding by using the hemostatic Agent monsel´s paste until no more bleeding is visible
OTHER	Wait and see	finishing examination without hemostatic intervention, awaiting spontaneous coagulation

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-01-01
• Completion: 2016-02-01
• First posted: 2015-07-01
• Last updated: 2016-02-17

Locations

2 sites across 1 country: Germany