Uterine Cervical DysplasiaNCT02910388
LLETZ Under Direct Colposcopic Vision
A study testing LLETZ with colposcopy and LLETZ without colposcopy in people with Uterine Cervical Dysplasia, run by Zydolab - Institute of Cytology and Immune Cytochemistry at 1 site in Germany.
Trial summary
To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct colposcopic Vision. 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?
- LLETZ with colposcopy and LLETZ without colposcopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2016to Dec 2017
- 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
- histologically proven cervical dysplasia
- colposcopy Prior to conization
- informed consent
Who cannot join
- significant language barrier
- a personal history of conization
- pregnancy
- the use of blood thinner
- unwillingness to participate
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Obstetrics and Gynecology of the Ruhr University Bochum
Herne, North Rhine-Westphalia, 44625
About this study
Official title: Direct Colposcopic Vision and Large Loop Excision of the Transformation Zone in Women With Cervical Dysplasia: a Randomized Controlled Trial.
To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct colposcopic Vision.
- Conditions
- Uterine Cervical Dysplasia
- Being tested
- LLETZ with colposcopy, LLETZ without colposcopy
- Keywords
- conization, LLETZ, loop excision, randomized controlled trial, colposcopy, direct colposcopic vision, intraoperative colposcopy
- 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.
LLETZ with colposcopyDevice
Loop procedure using a colposcope in order to see and remove the abnormal cervical tissue
LLETZ without colposcopyOther
Loop procedure without using a colposcope
| Study group | Role | What they receive |
|---|---|---|
| LLETZ with colposcopy | Experimental | The LLETZ procedure will be performed under direct colposcopic vision Receives: Device: LLETZ with colposcopy |
| LLETZ without colposcopy | Active comparator | The LLETZ procedure will be performed without colposcopy Receives: Other: LLETZ without colposcopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the resected cone mass
the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room
Measured: 10 minutes
Secondary outcomes (9)
Margin status
Resection margin is judge as "R0" if abnormal cells are not found in the margin of the biopsy or "R1" if abnormal cells remain in the margin of the biopsy. The histopathological examination will be done by an Independent pathologist
Measured: 2 Days after conization
Operation time
the time from the beginning of the Operation (start of the electrosurgical method) until the end of the operation (the end of hemostatic interventions) will be measured in minutes
Measured: 20 minutes
Operative complications
Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively
Measured: 14 days
number of fragments of the surgical specimen
surgeons will count the number of the surgical specimen (1 vs. >1)
Measured: 10 minutes
the dimensions of the surgical specimens
The circumference, length and thickness of The surgical specimens will be measured
Measured: 2 Days after conization
handling of the device
surgeons will score their preference regarding the surgical method using an 11-step visual analogue scale (VAS) for ,(ranging from 0 (,very easy') to 10 (,very difficult')
Measured: 30 minutes
satisfaction with the device
surgeons will score their preference regarding the surgical method using an 11-step visual analogue scale (VAS) for ,satisfaction with the device' (ranging from 0 (,very satisfied') to 10 (,absolutely not satisfied')
Measured: 30 minutes
Time to complete intraoperative hemostasis
the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds
Measured: 120 seconds
Intraoperative blood loss
intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2017
- Study completionDec 2017
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydolab - Institute of Cytology and Immune Cytochemistry
- Sponsor type
- University, hospital or other
- Collaborators
- Ruhr University of Bochum
- Responsible party
- Sponsor
- Investigators
- Ziad Hilal, M.D., Principal investigator, Zydolab - Institute of Cytology and Immune Cytochemistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910388
- Sponsor's protocol ID
- CONE-3
- Status last verified
- Dec 2017
- First submitted
- 15 Sep 2016
- Last updated
- 2 Jun 2020
- 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 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Colposcopic Vision and Large Loop Excision of the Transformation Zone in Women With Cervical Dysplasia: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02910388
- Acronym / sponsor ID
- CONE-3
- Conditions
- Uterine Cervical Dysplasia
- Keywords
- conization, LLETZ, loop excision, randomized controlled trial, colposcopy, direct colposcopic vision, intraoperative colposcopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Zydolab - Institute of Cytology and Immune CytochemistryUniversity, hospital or other
- Collaborators
- Ruhr University of Bochum
- Study start
- Oct 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 22 Sep 2016 (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.
To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct colposcopic Vision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLETZ with colposcopy | Experimental | Device: LLETZ with colposcopyThe LLETZ procedure will be performed under direct colposcopic vision |
| LLETZ without colposcopy | Active comparator | Other: LLETZ without colposcopyThe LLETZ procedure will be performed without colposcopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- histologically proven cervical dysplasia
- colposcopy Prior to conization
- informed consent
Key exclusion criteria (5 listed)
- significant language barrier
- a personal history of conization
- pregnancy
- the use of blood thinner
- 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 |
|---|---|---|
| LLETZ with colposcopyLoop procedure using a colposcope in order to see and remove the abnormal cervical tissue | Device | LLETZ with colposcopy |
| LLETZ without colposcopyLoop procedure without using a colposcope | Other | LLETZ without colposcopy |
Primary outcome
the resected cone mass
Time frame: 10 minutes
the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room
9 secondary outcomes
Margin status
Time frame: 2 Days after conization
Operation time
Time frame: 20 minutes
Operative complications
Time frame: 14 days
number of fragments of the surgical specimen
Time frame: 10 minutes
the dimensions of the surgical specimens
Time frame: 2 Days after conization
handling of the device
Time frame: 30 minutes
satisfaction with the device
Time frame: 30 minutes
Time to complete intraoperative hemostasis
Time frame: 120 seconds
Intraoperative blood loss
Time frame: 5 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 2 Jun 2020.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LLETZ with colposcopy and LLETZ without colposcopy in people with Uterine Cervical Dysplasia, run by Zydolab - Institute of Cytology and Immune Cytochemistry at 1 site 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 3 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 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
the resected cone mass (time frame: 10 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 2 Jun 2020.