Local Anaesthetic Complication Clinical Trial
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.
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.
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