Hemostatic Procedure After Biopsy of the Cervix
Is a Hemostatic Procedure Required After Biopsy of the Cervix Uteri in Women Undergoing Colposcopy for Cervical Dysplasia? A Multicenter Randomized Non-inferiority Trial
1 other identifier
interventional
166
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2015
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2015
CompletedFirst Posted
Study publicly available on registry
July 1, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFebruary 17, 2016
February 1, 2016
6 months
June 28, 2015
February 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Blood loss after 3 hours (5-step visual analogue scale)
3 hours
Blood loss after 6 hours (5-step visual analogue scale)
6 hours
Blood loss after 24 hours (5-step visual analogue scale)
24 hours
Sensation of pain after 15 minutes (10-step visual analogue scale)
15 minutes
Overall Sensation of pain after 24 hours (10-step visual analogue scale)
24 hours
- +1 more secondary outcomes
Study Arms (2)
Observational approach
OTHERWait and see
Use of Monsel´s Paste
ACTIVE COMPARATORcervical coagulation using a hemostatic agents, ie monsel´s paste
Interventions
surgical method to stop bleeding by using the hemostatic Agent monsel´s paste until no more bleeding is visible
finishing examination without hemostatic intervention, awaiting spontaneous coagulation
Eligibility Criteria
You may qualify if:
- abnormal pap smear
- first colposcopy ever
You may not qualify if:
- pregnancy
- bleeding disorder
- the use of blood thinner
- language barrier
- unwillingness to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Zydolab - Institute of Cytology and Immune Cytochemistry
Dortmund, North Rhine-Westphalia, 44137, Germany
Department of Obstetrics and Gynecology of the Ruhr University Bochum
Herne, North Rhine-Westphalia, 44625, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ziad Hilal, M. D.
Zydolab - Institute of Cytology and Immune Cytochemistry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med. Ziad Hilal
Study Record Dates
First Submitted
June 28, 2015
First Posted
July 1, 2015
Study Start
July 1, 2015
Primary Completion
January 1, 2016
Study Completion
February 1, 2016
Last Updated
February 17, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share