Hemostatic Procedure After Biopsy of the Cervix

NCT ID: NCT02486471

Last Updated: 2016-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Uterine Cervical Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Observational approach

Wait and see

Group Type OTHER

Wait and see

Intervention Type OTHER

finishing examination without hemostatic intervention, awaiting spontaneous coagulation

Use of Monsel´s Paste

cervical coagulation using a hemostatic agents, ie monsel´s paste

Group Type ACTIVE_COMPARATOR

Monsel´s Paste

Intervention Type PROCEDURE

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

Interventions

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Monsel´s Paste

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

Intervention Type PROCEDURE

Wait and see

finishing examination without hemostatic intervention, awaiting spontaneous coagulation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* abnormal pap smear
* first colposcopy ever

Exclusion Criteria

* pregnancy
* bleeding disorder
* the use of blood thinner
* language barrier
* unwillingness to participate
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zydolab - Institute of Cytology and Immune Cytochemistry

OTHER

Sponsor Role lead

Responsible Party

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Dr. med. Ziad Hilal

Dr. med. Ziad Hilal

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ziad Hilal, M. D.

Role: PRINCIPAL_INVESTIGATOR

Zydolab - Institute of Cytology and Immune Cytochemistry

Locations

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Zydolab - Institute of Cytology and Immune Cytochemistry

Dortmund, North Rhine-Westphalia, Germany

Site Status

Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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COLPO-1

Identifier Type: -

Identifier Source: org_study_id

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