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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

France1 site
  • Uhmontpellier

    Montpellier, 34295

Other trials in France

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.

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.

  1. 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.

  1. First posted17 May 2017
  2. Study start31 May 2017
  3. Primary completion30 Jun 2017
  4. Study completion30 Sep 2017

Resources

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)
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

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.

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