Hemostatic Procedure After Biopsy of the Cervix

Study Overview
=================
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.

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

Conditions
-----------------
Uterine Cervical Dysplasia

Intervention / Treatment
-----------------
* Procedure: Monsel´s Paste
* Other: Wait and see


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Observational approach<br>Wait and see | Other: Wait and see<br>* finishing examination without hemostatic intervention, awaiting spontaneous coagulation<br>|
| Active Comparator: Use of Monsel´s Paste<br>cervical coagulation using a hemostatic agents, ie monsel´s paste | Procedure: Monsel´s Paste<br>* surgical method to stop bleeding by using the hemostatic Agent monsel´s paste until no more bleeding is visible<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical dysplasia, colposcopy, haemostatic procedure, biopsy of the cervix uteri