Uterine Cervical DysplasiaNCT02486471
Hemostatic Procedure After Biopsy of the Cervix
A study testing Monsel´s Paste and Wait and see in people with Uterine Cervical Dysplasia, run by Zydolab - Institute of Cytology and Immune Cytochemistry at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Dysplasia
- What is being tested?
- Monsel´s Paste and Wait and see
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- abnormal pap smear
- first colposcopy ever
Who cannot join
- pregnancy
- bleeding disorder
- the use of blood thinner
- language barrier
- unwillingness to participate
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Zydolab - Institute of Cytology and Immune Cytochemistry
Dortmund, North Rhine-Westphalia, 44137
Department of Obstetrics and Gynecology of the Ruhr University Bochum
Herne, North Rhine-Westphalia, 44625
About this study
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
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.
- Conditions
- Uterine Cervical Dysplasia
- Being tested
- Monsel´s Paste, Wait and see
- Keywords
- cervical dysplasia, colposcopy, haemostatic procedure, biopsy of the cervix uteri
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monsel´s PasteProcedure or surgery
surgical method to stop bleeding by using the hemostatic Agent monsel´s paste until no more bleeding is visible
Wait and seeOther
finishing examination without hemostatic intervention, awaiting spontaneous coagulation
| Study group | Role | What they receive |
|---|---|---|
| Observational approach | Other | Wait and see Receives: Other: Wait and see |
| Use of Monsel´s Paste | Active comparator | cervical coagulation using a hemostatic agents, ie monsel´s paste Receives: Procedure: Monsel´s Paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 15 minutes
Secondary outcomes (6)
Blood loss after 3 hours (5-step visual analogue scale)
blood loss 3 hours after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale)
Measured: 3 hours
Blood loss after 6 hours (5-step visual analogue scale)
blood loss 6 hours after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale)
Measured: 6 hours
Blood loss after 24 hours (5-step visual analogue scale)
blood loss 24 hours after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale)
Measured: 24 hours
Sensation of pain after 15 minutes (10-step visual analogue scale)
patients will score their pain Level using a 10-step visual analogue scale (VAS) 15 minutes after biopsy
Measured: 15 minutes
Overall Sensation of pain after 24 hours (10-step visual analogue scale)
patients will score their pain Level using a 10-step visual analogue scale (VAS) 24 hours after biopsy
Measured: 24 hours
Overall Satisfaction of the Patient after 24 hours (10-step visual analogue scale)
patients will score their satisfaction Level using a 10-step visual analogue scale (VAS)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydolab - Institute of Cytology and Immune Cytochemistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Ziad Hilal, Zydolab - Institute of Cytology and Immune Cytochemistry
- Investigators
- Ziad Hilal, M. D., Principal investigator, Zydolab - Institute of Cytology and Immune Cytochemistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486471
- Sponsor's protocol ID
- COLPO-1
- Status last verified
- Feb 2016
- First submitted
- 28 Jun 2015
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02486471
- Acronym / sponsor ID
- COLPO-1
- Conditions
- Uterine Cervical Dysplasia
- Keywords
- cervical dysplasia, colposcopy, haemostatic procedure, biopsy of the cervix uteri
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Zydolab - Institute of Cytology and Immune CytochemistryUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational approach | Other | Other: Wait and seeWait and see |
| Use of Monsel´s Paste | Active comparator | Procedure: Monsel´s Pastecervical coagulation using a hemostatic agents, ie monsel´s paste |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- abnormal pap smear
- first colposcopy ever
Key exclusion criteria (5 listed)
- pregnancy
- bleeding disorder
- the use of blood thinner
- language barrier
- unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monsel´s Pastesurgical method to stop bleeding by using the hemostatic Agent monsel´s paste until no more bleeding is visible | Procedure or surgery | Use of Monsel´s Paste |
| Wait and seefinishing examination without hemostatic intervention, awaiting spontaneous coagulation | Other | Observational approach |
Primary outcome
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)
6 secondary outcomes
Blood loss after 3 hours (5-step visual analogue scale)
Time frame: 3 hours
Blood loss after 6 hours (5-step visual analogue scale)
Time frame: 6 hours
Blood loss after 24 hours (5-step visual analogue scale)
Time frame: 24 hours
Sensation of pain after 15 minutes (10-step visual analogue scale)
Time frame: 15 minutes
Overall Sensation of pain after 24 hours (10-step visual analogue scale)
Time frame: 24 hours
Overall Satisfaction of the Patient after 24 hours (10-step visual analogue scale)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziad Hilal, M. D. principal investigator
Zydolab - Institute of Cytology and Immune Cytochemistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monsel´s Paste and Wait and see in people with Uterine Cervical Dysplasia, run by Zydolab - Institute of Cytology and Immune Cytochemistry at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss after 15 minutes (5-step visual analogue scale) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.