Hemostatic Procedure After Biopsy of the Cervix

• Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry (Other)
• Overall Status: Completed
• CT.gov ID: NCT02486471
• Collaborator: (none)
• Enrollment: 166
• Locations: 2
• Arms: 2
• Duration (Months): 7.1
• Patients Per Site: 83
• Patients Per Site Per Month: 11.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Dysplasia	Procedure: Monsel´s Paste; Other: Wait and see	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 166 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Official 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
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Blood loss after 15 minutes (5-step visual analogue scale) [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 Outcome Measures

1. Blood loss after 3 hours (5-step visual analogue scale) [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) [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) [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) [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) [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) [24 hours]

   patients will score their satisfaction Level using a 10-step visual analogue scale (VAS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• abnormal pap smear

• first colposcopy ever

Exclusion Criteria:

• pregnancy

• bleeding disorder

• the use of blood thinner

• language barrier

• unwillingness to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zydolab - Institute of Cytology and Immune Cytochemistry	Dortmund	NRW	Germany	44137
2	Department of Obstetrics and Gynecology of the Ruhr University Bochum	Herne	NRW	Germany	44625

Sponsors and Collaborators

• Zydolab - Institute of Cytology and Immune Cytochemistry

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. med. Ziad Hilal, Dr. med. Ziad Hilal, Zydolab - Institute of Cytology and Immune Cytochemistry
• ClinicalTrials.gov Identifier: NCT02486471
• Other Study ID Numbers: COLPO-1
• First Posted: Jul 1, 2015
• Last Update Posted: Feb 17, 2016
• Last Verified: Feb 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Dr. med. Ziad Hilal, Dr. med. Ziad Hilal, Zydolab - Institute of Cytology and Immune Cytochemistry: cervical dysplasia; colposcopy; haemostatic procedure; biopsy of the cervix uteri
• Additional relevant MeSH terms: Uterine Cervical Dysplasia; Cervical Intraepithelial Neoplasia

Study Results

No Results Posted as of Feb 17, 2016