Local Anaesthetic ComplicationESCALNCT03157752
Evaluation of the Satisfaction of Patients With Conization Under Local Anesthesia
An observational study of Local Anaesthetic Complication, run by University Hospital, Montpellier at 1 site in France.
Trial summary
In France, screening involves a routine test of papanicolaou in women aged 25 to 65 years. In the case of an abnormal Pap smear discovery, the diagnostic strategy is based in most cases in colscopy to allow cervical biopsies if necessary to obtain a histological diagnosis of high quality cervical intraepithelial… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Local Anaesthetic Complication
- What is being tested?
- Quality of life questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2017to 30 Sep 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
- Women only
- Adult, Older adult
Study population: Patient requiring conization on the CHU of Montpellier or Nîmes and having chosen a local anesthesia.
Who may be able to join
- Age greater than or equal to 18 years
- Patient requiring conization on the CHU of Montpellier or Nîmes and having chosen a local anesthesia.
- Informed and not opposed to participate in this research
Who cannot join
- Contra-indication to local anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Satisfaction of Patients With Conization Under Local Anesthesia, Prospective Study
In France, screening involves a routine test of papanicolaou in women aged 25 to 65 years. In the case of an abnormal Pap smear discovery, the diagnostic strategy is based in most cases in colscopy to allow cervical biopsies if necessary to obtain a histological diagnosis of high quality cervical intraepithelial neoplasia (CIN) (2- 3) which, if persistent, can cause cervical cancer. Their results, also in the case of the persistence of a low-level lesion or of a cyto-histological discordance, indicate conization. Conization is a procedure performed by resection of the diathermic grip, allowing a simple and fast gesture compatible with a load under local anesthesia. In order to simplify the overall cost of the patient, more and more conizations of Montpellier and Nimes take place under local anesthesia. .
The main objective of our study is to evaluate the overall satisfaction of patients in the case of conisation under local anesthesia.
The goal is to promote local anesthesia for the management of congested patients, which simplifies overall management, reduces cost and reduces complications associated with general anesthesia.
Read the detailed description
In France the screening is on the regular realization of a papanicolaou test (Pap smear or Pap test) in women aged 25 to 65 years. In the event of abnormal Pap smear discovery, the diagnostic strategy is based in most cases on colscopy to allow for cervical biopsies if necessary to obtain a histological diagnosis for cervical intraepithelial neoplasia (CIN ) High grade (2-3) which, if persistent, may cause cervical cancer. Their findings, also in the case of persistence of low-grade lesion or cyto-histological discordance, indicate conization. The conization is an intervention realized by resection to the diathermic handle, allowing a simple and fast gesture compatible with a charge under local anesthesia. With a view to simplify the overall cost of the patient, more and more conizations of the Montpellier and Nimes are carried out under local anesthesia. A retrospective study found a good overall satisfaction of the patients with conisation under local anesthesia, it is interesting to continue this study by an evaluation of the patient's satisfaction in the prospective way, including validated rankings and to allow a risk assessment And the persistence of lesions.
The main objective of our study is to evaluate the overall satisfaction of the patients in the case of conducting conization under local anesthesia. Secondary endpoints are preoperative anxiety assessed using the Visual Analog Scale (EVA) And the Amsterdam Preoperative Anxiety and Information Scale (APAIS) score, the occurrence of complications during the procedure, surgeon satisfaction, anesthesia tolerance using the Iowa Satisfaction with Anesthesia Scale score (ISAIS), and finally A follow-up at 3 months evaluation of secondary complications, margins of resections and persistence of lesions.
This is a prospective multi-centric study (CHU Nîmes and Montpellier). During the day hospitalization, a questionnaire of satisfaction will be given to the patient. The primary outcome measure is the overall satisfaction of the patient assessed as a question. Secondary endpoints are preoperative anxiety assessed using the visual analog scale (EVA) and the Amsterdam Preoperative Anxiety and Information scale (APAIS) score, the occurrence of complications during gesture, satisfaction of the surgeon , Tolerance of anesthesia using the ISAS score, and finally a 3-month follow-up to evaluate secondary complications, resection margins and lesions persistence. Currently the only study on the subject is a retrospective study of 70 subjects. This study reported a proportion of patients with little or no satisfaction of 11.4%. Recruiting 80 patients will confirm this rate with an accuracy of +/- 7%.
The questionnaire will be given on the day of surgery and completed before surgery, immediately after surgery and before final discharge. Secondarily, the data will be supplemented during a postoperative control visit at 3 months of the intervention. The expected duration of the inclusions is 10 months with follow-up at 3 months
The aim is to promote local anesthesia for the management of congested patients, thus simplifying the overall management, reducing the cost and reducing the complications associated with general anesthesia.
- Conditions
- Local Anaesthetic Complication
- Being tested
- Quality of life questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnaireBehavioural
Quality of life questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfactio
Overall satisfaction of the patient, evaluated by the completion of a questionnaire on the day of the intervention.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start31 May 2017
- Primary completion30 Jun 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Anaesthetic ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes
- Responsible party
- Sponsor
- Investigators
- Elsa MARIS, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157752
- Sponsor's protocol ID
- RECHMPL17_0145
- Acronym
- ESCAL
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Satisfaction of Patients With Conization Under Local Anesthesia, Prospective Study
- ClinicalTrials.gov ID
- NCT03157752
- Acronym / sponsor ID
- ESCAL / RECHMPL17_0145
- Conditions
- Local Anaesthetic Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes
- Study start
- 31 May 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 17 May 2017 (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.
In France, screening involves a routine test of papanicolaou in women aged 25 to 65 years. In the case of an abnormal Pap smear discovery, the diagnostic strategy is based in most cases in colscopy to allow cervical biopsies if necessary to obtain a histological diagnosis of high quality cervical intraepithelial neoplasia (CIN) (2- 3) which, if persistent, can cause cervical cancer. Their results, also in the case of the persistence of a low-level lesion or of a cyto-histological discordance, indicate conization. Conization is a procedure performed by resection of the diathermic grip, allowing a simple and fast gesture compatible with a load under local anesthesia. In order to simplify the overall cost of the patient, more and more conizations of Montpellier and Nimes take place under local anesthesia. .
The main objective of our study is to evaluate the overall satisfaction of patients in the case of conisation under local anesthesia.
The goal is to promote local anesthesia for the management of congested patients, which simplifies overall management, reduces cost and reduces complications associated with general anesthesia.
Detailed description
In France the screening is on the regular realization of a papanicolaou test (Pap smear or Pap test) in women aged 25 to 65 years. In the event of abnormal Pap smear discovery, the diagnostic strategy is based in most cases on colscopy to allow for cervical biopsies if necessary to obtain a histological diagnosis for cervical intraepithelial neoplasia (CIN ) High grade (2-3) which, if persistent, may cause cervical cancer. Their findings, also in the case of persistence of low-grade lesion or cyto-histological discordance, indicate conization. The conization is an intervention realized by resection to the diathermic handle, allowing a simple and fast gesture compatible with a charge under local anesthesia. With a view to simplify the overall cost of the patient, more and more conizations of the Montpellier and Nimes are carried out under local anesthesia. A retrospective study found a good overall satisfaction of the patients with conisation under local anesthesia, it is interesting to continue this study by an evaluation of the patient's satisfaction in the prospective way, including validated rankings and to allow a risk assessment And the persistence of lesions.
The main objective of our study is to evaluate the overall satisfaction of the patients in the case of conducting conization under local anesthesia. Secondary endpoints are preoperative anxiety assessed using the Visual Analog Scale (EVA) And the Amsterdam Preoperative Anxiety and Information Scale (APAIS) score, the occurrence of complications during the procedure, surgeon satisfaction, anesthesia tolerance using the Iowa Satisfaction with Anesthesia Scale score (ISAIS), and finally A follow-up at 3 months evaluation of secondary complications, margins of resections and persistence of lesions.
This is a prospective multi-centric study (CHU Nîmes and Montpellier). During the day hospitalization, a questionnaire of satisfaction will be given to the patient. The primary outcome measure is the overall satisfaction of the patient assessed as a question. Secondary endpoints are preoperative anxiety assessed using the visual analog scale (EVA) and the Amsterdam Preoperative Anxiety and Information scale (APAIS) score, the occurrence of complications during gesture, satisfaction of the surgeon , Tolerance of anesthesia using the ISAS score, and finally a 3-month follow-up to evaluate secondary complications, resection margins and lesions persistence. Currently the only study on the subject is a retrospective study of 70 subjects. This study reported a proportion of patients with little or no satisfaction of 11.4%. Recruiting 80 patients will confirm this rate with an accuracy of +/- 7%.
The questionnaire will be given on the day of surgery and completed before surgery, immediately after surgery and before final discharge. Secondarily, the data will be supplemented during a postoperative control visit at 3 months of the intervention. The expected duration of the inclusions is 10 months with follow-up at 3 months
The aim is to promote local anesthesia for the management of congested patients, thus simplifying the overall management, reducing the cost and reducing the complications associated with general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patient requiring conization on the CHU of Montpellier or Nîmes and having chosen a local anesthesia.
Key inclusion criteria (3 listed)
- Age greater than or equal to 18 years
- Patient requiring conization on the CHU of Montpellier or Nîmes and having chosen a local anesthesia.
- Informed and not opposed to participate in this research
Key exclusion criteria (1 listed)
- Contra-indication to local anesthesia
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 |
|---|---|---|
| Quality of life questionnaireQuality of life questionnaire | Behavioural | – |
Primary outcome
Patient satisfactio
Time frame: 1 day
Overall satisfaction of the patient, evaluated by the completion of a questionnaire on the day of the intervention.
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 5 Dec 2017.
- Individual participant dataSharing planned: Undecided. NC
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.
Elsa MARIS principal investigator
University Hospital, Montpellier
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 Local Anaesthetic Complication, run by University Hospital, Montpellier 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 3 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 5 Dec 2017. 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?
Patient satisfactio (time frame: 1 day). 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 5 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.