AnesthesiaLEEP-DIMNCT03737526
Impact of Anaesthesia Mode on Evaluation of LEEP Specimen Dimensions
An observational study of Anesthesia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
To study the influence of anaesthesia (local by cervical block vs. general or spinal anaesthesia) on height and volume of resection specimens in case of conization treatment for cervical intraepithelial neoplasia (CIN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- How many people
- 107 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2015to 1 Jan 2017
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators conducted a prospective non-randomized controlled study at the Amiens University Hospital (France). The study took place between January and December 2015. The investigators included every patient who underwent a first conization procedure, regardless of indication. The only exclusion criterion was the patient's refusal to participate.Written consent was obtained before procedure. Data was gathered using questionnaires, pre-, per- and post-procedure.
Who may be able to join
- every patient who underwent a first conization procedure
- regardless of indication
Who cannot join
- patient's refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
To study the influence of anaesthesia (local by cervical block vs. general or spinal anaesthesia) on height and volume of resection specimens in case of conization treatment for cervical intraepithelial neoplasia (CIN).
Prospective observational study of all patients who underwent a first treatment by loop electrosurgical excision procedure (LEEP) for CIN. Height of fresh resection specimens was first measured by the operator and then by the pathologist after formaldehyde fixation. Volume of fresh specimens was measured in a measuring cylinder by fluid displacement.
Read the detailed description
Measure of conization specimens can be done in the operating theatre on fresh specimen or by pathologist after fixation. Methods and conditions of specimen measurement are rarely, if ever, described in published studies.
To study the influence of anaesthesia (local by cervical block vs. general or spinal anaesthesia) on height and volume of resection specimens in case of conization treatment for cervical intraepithelial neoplasia (CIN).
Prospective observational study of all patients who underwent a first treatment by loop electrosurgical excision procedure (LEEP) for CIN. Height of fresh resection specimens was first measured by the operator and then by the pathologist after formaldehyde fixation. Volume of fresh specimens was measured in a measuring cylinder by fluid displacement.
- Conditions
- Anesthesia
- Keywords
- loop electrosurgical excision procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of anaesthesia on height of resection specimens.
evaluate the impact of the excision procedure technique by the mode of anesthesia using the loop electrosurgical on height of resection specimens in case of conization treatment for cervical intraepithelial neoplasia.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Jan 2015
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Gondry, PU-PH, Principal investigator, CHU AMIENS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737526
- Sponsor's protocol ID
- PI2017_843_0050
- Acronym
- LEEP-DIM
- Status last verified
- Jun 2026
- First submitted
- 17 Sep 2018
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anaesthesia Mode on Evaluation of LEEP Specimen Dimensions
- ClinicalTrials.gov ID
- NCT03737526
- Acronym / sponsor ID
- LEEP-DIM / PI2017_843_0050
- Conditions
- Anesthesia
- Keywords
- loop electrosurgical excision procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 9 Nov 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.
To study the influence of anaesthesia (local by cervical block vs. general or spinal anaesthesia) on height and volume of resection specimens in case of conization treatment for cervical intraepithelial neoplasia (CIN).
Prospective observational study of all patients who underwent a first treatment by loop electrosurgical excision procedure (LEEP) for CIN. Height of fresh resection specimens was first measured by the operator and then by the pathologist after formaldehyde fixation. Volume of fresh specimens was measured in a measuring cylinder by fluid displacement.
Detailed description
Measure of conization specimens can be done in the operating theatre on fresh specimen or by pathologist after fixation. Methods and conditions of specimen measurement are rarely, if ever, described in published studies.
To study the influence of anaesthesia (local by cervical block vs. general or spinal anaesthesia) on height and volume of resection specimens in case of conization treatment for cervical intraepithelial neoplasia (CIN).
Prospective observational study of all patients who underwent a first treatment by loop electrosurgical excision procedure (LEEP) for CIN. Height of fresh resection specimens was first measured by the operator and then by the pathologist after formaldehyde fixation. Volume of fresh specimens was measured in a measuring cylinder by fluid displacement.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators conducted a prospective non-randomized controlled study at the Amiens University Hospital (France). The study took place between January and December 2015. The investigators included every patient who underwent a first conization procedure, regardless of indication. The only exclusion criterion was the patient's refusal to participate.Written consent was obtained before procedure. Data was gathered using questionnaires, pre-, per- and post-procedure.
Key inclusion criteria (2 listed)
- every patient who underwent a first conization procedure
- regardless of indication
Key exclusion criteria (1 listed)
- patient's refusal 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.
Primary outcome
Impact of anaesthesia on height of resection specimens.
Time frame: 1 year
evaluate the impact of the excision procedure technique by the mode of anesthesia using the loop electrosurgical on height of resection specimens in case of conization treatment for cervical intraepithelial neoplasia.
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 16 Jun 2026.
- 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.
Jean Gondry, PU-PH principal investigator
CHU AMIENS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 1 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 16 Jun 2026. 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 France. 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?
Impact of anaesthesia on height of resection specimens. (time frame: 1 year). 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 16 Jun 2026.