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Pilot Study for Thyroid Surgery by Preoperative Video Support and Personalized and Secure Web Platform (AMEDOP)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Enrolling

Conditions

Thyroid

Treatments

Other: access to the internet information platform

Study type

Interventional

Funder types

Other

Identifiers

NCT04571736
RECHMPL19_0085 (7782)
2019-A02241-56 (Other Identifier)

Details and patient eligibility

About

The medical information delivered to the patient before any surgery constitutes an essential and compulsory step during the initial management of the operated patient.

There are different reasons for the quantity and quality of medical information retained by the patient. An internet platform with personalized and secure access has been developed. This platform contains, among other things, an explanatory video of thyroid surgery and allows the patient to have access to information on surgical management at any time.

The investigators believe that unlimited access for the duration of the study to this platform could reduce the preoperative anxiety level of patients.

Full description

The objective is to assess the impact of additional, personalized and accessible preoperative medical information via a secure internet platform on the anxiety level of patients before their surgery. For this, patients agreeing to participate in the study will be randomized (drawn at random) during the inclusion visit and divided into one of the following two groups:

  • The control group: patients included in this group will receive the usual medical information as part of the surgery performed;
  • The experimental group: the patients included in this group will have, in addition to the usual medical information, personalized and secure access to a platform so that they can have additional information on the surgery performed.

Enrollment

220 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age between 18 and 75,
  • Indication of lobo-isthmectomy or total thyroidectomy
  • Compliance for the completion of self-questionnaires
  • Person affiliated or beneficiary of a social security scheme.
  • Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion criteria

  • Difficulty understanding the French language
  • Lack of internet access
  • Persons placed under the protection of justice,
  • Person under guardianship or curatorship
  • Person participating in another research including an exclusion period still in progress,
  • Subject with severely impaired physical and / or psychological health, which, according to the investigator, may affect the compliance of the study participant
  • Pregnant / lactating woman

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

220 participants in 2 patient groups

access to the internet information platform
Active Comparator group
Description:
usual preoperative information and access to the internet information platform
Treatment:
Other: access to the internet information platform
usual preoperative information
No Intervention group
Description:
medical information delivered to the patient before any surgery

Trial contacts and locations

1

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Central trial contact

Cesar Cartier, PI; Susana Leornard, CRA

Data sourced from clinicaltrials.gov

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