NCT03157752

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

May 31, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

December 5, 2017

Status Verified

May 1, 2017

Enrollment Period

1 month

First QC Date

May 15, 2017

Last Update Submit

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

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

Study Officials

  • Elsa MARIS

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

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

Locations