Hemostatic Procedure After Biopsy of the Cervix

February 13, 2016 updated by: Dr. med. Ziad Hilal, Zydolab - Institute of Cytology and Immune Cytochemistry

Is a Hemostatic Procedure Required After Biopsy of the Cervix Uteri in Women Undergoing Colposcopy for Cervical Dysplasia? A Multicenter Randomized Non-inferiority Trial

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Dortmund, NRW, Germany, 44137
        • Zydolab - Institute of Cytology and Immune Cytochemistry
      • Herne, NRW, Germany, 44625
        • Department of Obstetrics and Gynecology of the Ruhr University Bochum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • abnormal pap smear
  • first colposcopy ever

Exclusion Criteria:

  • pregnancy
  • bleeding disorder
  • the use of blood thinner
  • language barrier
  • unwillingness to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss after 15 minutes (5-step visual analogue scale)
Time Frame: 15 minutes
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)
Time Frame: 3 hours
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)
Time Frame: 6 hours
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)
Time Frame: 24 hours
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)
Time Frame: 15 minutes
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)
Time Frame: 24 hours
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)
Time Frame: 24 hours
patients will score their satisfaction Level using a 10-step visual analogue scale (VAS)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry

Investigators

  • Principal Investigator: Ziad Hilal, M. D., Zydolab - Institute of Cytology and Immune Cytochemistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 28, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 13, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLPO-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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