Evaluation of the Satisfaction of Patients With Conization Under Local Anesthesia
ESCAL
1 other identifier
observational
80
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedStudy Start
First participant enrolled
May 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2017
CompletedDecember 5, 2017
May 1, 2017
1 month
May 15, 2017
December 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Patient satisfactio
Overall satisfaction of the patient, evaluated by the completion of a questionnaire on the day of the intervention.
1 day
Interventions
Quality of life questionnaire
Eligibility Criteria
Patient requiring conization on the CHU of Montpellier or Nîmes and having chosen a local anesthesia.
You may qualify if:
- 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
You may not qualify if:
- Contra-indication to local anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uhmontpellier
Montpellier, 34295, France
Study Officials
- PRINCIPAL INVESTIGATOR
Elsa MARIS
University Hospital, Montpellier
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2017
First Posted
May 17, 2017
Study Start
May 31, 2017
Primary Completion
June 30, 2017
Study Completion
September 30, 2017
Last Updated
December 5, 2017
Record last verified: 2017-05