Uterine Cervical DysplasiaNCT03494686
LLETZ Under General Versus Local Anesthesia
A study testing LLETZ under local anaesthesia and LLETZ under general anaesthesia in people with Uterine Cervical Dysplasia, run by Zydolab - Institute of Cytology and Immune Cytochemistry at 1 site in Germany.
Trial summary
The investigators conduct a prospective, randomized trial to assess the benefits of performing large loop excision of the transformatione zone (LLETZ) under local anesthesia and compare it to LLETZ under general anesthesia. The primary endpoint of this study is women´s satisfaction. 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 under local anaesthesia and LLETZ under general anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteGermany
- Study dates
- 3 Apr 2018to 14 Mar 2020
- 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
- colposcopy Prior to conization
- informed consent
- histologically proven high grade cervical dysplasia
- Transformation zone typ 1 or 2
Who cannot join
- significant language barrier
- a personal history of conization
- pregnancy
- the use of blood thinner
- unwillingness to participate
- oncological disease
Show all 10Show fewer
- inpatient treatment
- women who are not fasting
- risk of aspiration
- columnar-squamous epithelium border not fully visible
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: Large Loop Excision of the Transformatione Zone Under General Versus Local Anesthesia: a Randomized Trial.
The investigators conduct a prospective, randomized trial to assess the benefits of performing large loop excision of the transformatione zone (LLETZ) under local anesthesia and compare it to LLETZ under general anesthesia. The primary endpoint of this study is women´s satisfaction.
- Conditions
- Uterine Cervical Dysplasia
- Being tested
- LLETZ under local anaesthesia, LLETZ under general anaesthesia
- Keywords
- conization, LLETZ, randomized controlled trial, loop excision, general anaesthesia, local anaesthesia
- 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 under local anaesthesiaProcedure or surgery
Conization will be performed under local anaesthesia
LLETZ under general anaesthesiaProcedure or surgery
Conization will be performed under general anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| LLETZ under local anaesthesia | Experimental | The LLETZ procedure will be performed under local anaesthesia Receives: Procedure: LLETZ under local anaesthesia |
| LLETZ under general anaesthesia | Active comparator | The LLETZ procedure will be performed under general anaesthesia Receives: Procedure: LLETZ under general anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Womens satisfaction
Patients will score their satisfaction by using a 11-step visual analogue scale (VAS) ranging from '0' ("not satisfied at all") to '10' ("very satisfied") 2 hours after Treatment
Measured: 2 hours
Secondary outcomes (10)
Postoperative pain
patients will score their postoperative pain Level using a 11-step visual analogue scale (VAS) ranging from '0' ("no pain" ) to '10' ("maximum pain") within 2 hours after surgery
Measured: 2 hours
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
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
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
Surgeons satisfaction
Surgeons will score their satisfaction by using a 11-step visual analogue scale (VAS) 20 minutes after Treatment
Measured: 20 minutes
number of fragments of the surgical specimen
surgeons will count the number of the surgical specimen (1 vs. >1)
Measured: 20 minutes
the dimensions of the surgical specimens
The circumference, length and thickness of The surgical specimens will be measured
Measured: 20 minutes
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start3 Apr 2018
- Primary completion28 Feb 2020
- Study completion14 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydolab - Institute of Cytology and Immune Cytochemistry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ziad Hilal, M.D., Principal investigator, Zydolab - Institute of Cytology and Immune Cytochemistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494686
- Sponsor's protocol ID
- CONE-4
- Status last verified
- Mar 2020
- First submitted
- 3 Apr 2018
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rezniczek GA, Hecken JM, Rehman S, Dogan A, Tempfer CB, Hilal Z. Syringe or mask? Loop electrosurgical excision procedure under local or general anesthesia: a randomized trial. Am J Obstet Gynecol. 2020 Dec;223(6):888.e1-888.e9. doi: 10.1016/j.ajog.2020.06.041. Epub 2020 Jul 24.
PubMed 32585223
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large Loop Excision of the Transformatione Zone Under General Versus Local Anesthesia: a Randomized Trial.
- ClinicalTrials.gov ID
- NCT03494686
- Acronym / sponsor ID
- CONE-4
- Conditions
- Uterine Cervical Dysplasia
- Keywords
- conization, LLETZ, randomized controlled trial, loop excision, general anaesthesia, local anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Zydolab - Institute of Cytology and Immune CytochemistryUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 14 Mar 2020 (actual)
- First posted
- 11 Apr 2018 (actual)
- 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.
The investigators conduct a prospective, randomized trial to assess the benefits of performing large loop excision of the transformatione zone (LLETZ) under local anesthesia and compare it to LLETZ under general anesthesia. The primary endpoint of this study is women´s satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLETZ under local anaesthesia | Experimental | Procedure: LLETZ under local anaesthesiaThe LLETZ procedure will be performed under local anaesthesia |
| LLETZ under general anaesthesia | Active comparator | Procedure: LLETZ under general anaesthesiaThe LLETZ procedure will be performed under general anaesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- colposcopy Prior to conization
- informed consent
- histologically proven high grade cervical dysplasia
- Transformation zone typ 1 or 2
Key exclusion criteria (10 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 under local anaesthesiaConization will be performed under local anaesthesia | Procedure or surgery | LLETZ under local anaesthesia |
| LLETZ under general anaesthesiaConization will be performed under general anaesthesia | Procedure or surgery | LLETZ under general anaesthesia |
Primary outcome
Womens satisfaction
Time frame: 2 hours
Patients will score their satisfaction by using a 11-step visual analogue scale (VAS) ranging from '0' ("not satisfied at all") to '10' ("very satisfied") 2 hours after Treatment
10 secondary outcomes
Postoperative pain
Time frame: 2 hours
the resected cone mass
Time frame: 10 minutes
Operation time
Time frame: 20 minutes
Operative complications
Time frame: 14 days
Time to complete intraoperative hemostasis
Time frame: 120 seconds
Surgeons satisfaction
Time frame: 20 minutes
number of fragments of the surgical specimen
Time frame: 20 minutes
the dimensions of the surgical specimens
Time frame: 20 minutes
Intraoperative blood loss
Time frame: 5 hours
Margin status
Time frame: 2 days after conization
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 23 Mar 2020.
- Derived from this study: PubMed 32585223Rezniczek GA, Hecken JM, Rehman S, Dogan A, Tempfer CB, Hilal Z. Syringe or mask? Loop electrosurgical excision procedure under local or general anesthesia: a randomized trial. Am J Obstet Gynecol. 2020 Dec;223(6):888.e1-888.e9. doi: 10.1016/j.ajog.2020.06.041. Epub 2020 Jul 24.
- 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 under local anaesthesia and LLETZ under general anaesthesia 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 4 inclusion and 10 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 23 Mar 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?
Womens satisfaction (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03494686, which also lists 1 linked publication.
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 23 Mar 2020; AzTrials last refreshed its copy on 28 Oct 2026.