Hemostatic Procedure After Biopsy of the Cervix

Uterine Cervical Dysplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486471
• Other study ID #: COLPO-1
• Status: Completed
• Phase: N/A
• First received: June 28, 2015
• Last updated: February 13, 2016
• Start date: July 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Zydolab - Institute of Cytology and Immune Cytochemistry
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• abnormal pap smear

• first colposcopy ever

Exclusion Criteria:

• pregnancy

• bleeding disorder

• the use of blood thinner

• language barrier

• unwillingness to participate

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia

Intervention

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

Locations

Country	Name	City	State
Germany	Zydolab - Institute of Cytology and Immune Cytochemistry	Dortmund	NRW
Germany	Department of Obstetrics and Gynecology of the Ruhr University Bochum	Herne	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Zydolab - Institute of Cytology and Immune Cytochemistry

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss after 15 minutes (5-step visual analogue scale)	blood loss 15 minutes after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale)	15 minutes	No
Secondary	Blood loss after 3 hours (5-step visual analogue scale)	blood loss 3 hours after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale)	3 hours	No
Secondary	Blood loss after 6 hours (5-step visual analogue scale)	blood loss 6 hours after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale)	6 hours	No
Secondary	Blood loss after 24 hours (5-step visual analogue scale)	blood loss 24 hours after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale)	24 hours	No
Secondary	Sensation of pain after 15 minutes (10-step visual analogue scale)	patients will score their pain Level using a 10-step visual analogue scale (VAS) 15 minutes after biopsy	15 minutes	No
Secondary	Overall Sensation of pain after 24 hours (10-step visual analogue scale)	patients will score their pain Level using a 10-step visual analogue scale (VAS) 24 hours after biopsy	24 hours	No
Secondary	Overall Satisfaction of the Patient after 24 hours (10-step visual analogue scale)	patients will score their satisfaction Level using a 10-step visual analogue scale (VAS)	24 hours	No