Hemostatic Procedure After Biopsy of the Cervix

Zydolab - Institute of Cytology and Immune Cytochemistry166 enrolled

Overview

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

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

166

Conditions

Uterine Cervical Dysplasia

Interventions

Monsel´s PastePROCEDURE

surgical method to stop bleeding by using the hemostatic Agent monsel´s paste until no more bleeding is visible

Wait and seeOTHER

finishing examination without hemostatic intervention, awaiting spontaneous coagulation

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * abnormal pap smear * first colposcopy ever Exclusion Criteria: * pregnancy * bleeding disorder * the use of blood thinner * language barrier * unwillingness to participate

Locations (2)

Zydolab - Institute of Cytology and Immune Cytochemistry

Dortmund, North Rhine-Westphalia, Germany

Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

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)

Time frame: 15 minutes

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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)

Data from ClinicalTrials.gov

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