Brief Title
Hemostatic Procedure After Biopsy of the Cervix
Official Title
Is a Hemostatic Procedure Required After Biopsy of the Cervix Uteri in Women Undergoing Colposcopy for Cervical Dysplasia? A Multicenter Randomized Non-inferiority Trial
Brief 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.
Study Type
Interventional
Primary Outcome
Blood loss after 15 minutes (5-step visual analogue scale)
Secondary Outcome
Blood loss after 3 hours (5-step visual analogue scale)
Condition
Uterine Cervical Dysplasia
Intervention
Monsel´s Paste
Study Arms / Comparison Groups
Observational approach
Description: Wait and see
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
166
Start Date
July 2015
Completion Date
February 2016
Primary Completion Date
January 2016
Eligibility Criteria
Inclusion Criteria: - abnormal pap smear - first colposcopy ever Exclusion Criteria: - pregnancy - bleeding disorder - the use of blood thinner - language barrier - unwillingness to participate
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ziad Hilal, M. D., ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT02486471
Organization ID
COLPO-1
Responsible Party
Principal Investigator
Study Sponsor
Zydolab - Institute of Cytology and Immune Cytochemistry
Study Sponsor
Ziad Hilal, M. D., Principal Investigator, Zydolab - Institute of Cytology and Immune Cytochemistry
Verification Date
February 2016