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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02486471
Other study ID # COLPO-1
Secondary ID
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)


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
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