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Completed

NCT Number: NCT02486471

Hemostatic Procedure After Biopsy of the Cervix

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.

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Key information

Conditions

Uterine Cervical Dysplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zydolab - Institute of Cytology and Immune Cytochemistry, Dortmund, North Rhine-Westphalia, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • abnormal pap smear
  • first colposcopy ever

Exclusion criteria

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

Treatment and study plan

Monsel´s Paste

Procedure

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

Wait and see

Other

finishing examination without hemostatic intervention, awaiting spontaneous coagulation

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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

  6. 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)

Sponsors and collaborators

Lead sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 1, 2015
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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