Prospective Evaluation of the Impact of Pre-operative Device on the Personal Experience of Brain Awake Surgery (EVECHE)

Prospective Evaluation of the Impact of Pre-operative Device on the Personal Experience of Brain Awake Surgery: Comparative Study, Randomized

The brain awake surgery has recently boomed in neurosurgical oncology but also in epilepsy surgery. The goal of awake surgery is to allow a more precise localization of sensorimotor functions, languages and cognitive to better respect them. Indeed, the interindividual anatomo-functional variations, the lack of specificity of functional explorations radiological magnetic or nuclear, as well as the reorganization of the areas involved in these functions (mechanisms of brain plasticity) in epileptic patients or patients with cerebral tumor do not allow to identify them in preoperatively. Brain awake surgery allows an analysis and a precise real-time identification of areas and networks involved in these functions through a direct electrical stimulation (inhibitory or activatory). Thus, this surgical technique has become a gold standard in surgery of brain lesions located in functional areas.

However, although the brain awake surgery has been practiced since many years, the confidentiality of these informations until recent years explains probably that very little data to be available on the personal experience of this procedure by patients. Studies that have analyzed the perception of the patient or the satisfaction of the patient after surgery in awake conditions were retrospective and included few patients. The investigators experience of lived of this surgery that the investigators have developed in the investigators team since over four years is that on the whole awake surgery is well tolerated if adequate explanations are provided preoperatively and if a minimum of preoperative precautions are observed.

Thus, the investigators have decided to develop a preoperative device that could improve personal experience and well-being of patients undergoing this surgical approach.

Study Overview

• Status: Unknown
• Conditions: Brain Awake Surgery
• Intervention / Treatment: Device: preoperative adequate explanations about awake surgery; Other: no preoperative explanation

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille cedex 5, France, 13354
    • Recruiting
    • Assistance Publique Hôpitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject with a low grade glioma targeted for intervention in the awake brain surgery;
• Subject able to complete a self-administered questionnaire;
• Subjects who have signed a written informed consent and agreeing to abide by the instructions of the protocol

Exclusion Criteria:

• Minor, pregnant or lactating women, not affiliated to the social security system;
• Subject severe respiratory failure;
• Subjects treated with antipsychotic (neuroleptic or lithium);
• Subjects with cognitive impairment degenerative previously documented (Alzheimer, dementia other);
• subject active addict;
• Subject with personal psychiatric history;

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with preoperative device; patients undergoing brain awake surgery with adequate explanations which are provided preoperatively. Preoperative device corresponds to a pre/ perioperative coaching involving the provision of a comprehensive information support on the awake surgery (short video and information brochure) and an interview with an operating room nurse	Device: preoperative adequate explanations about awake surgery
Active Comparator: Patient with standard procedure; patients undergoing brain awake surgery with standard procedure (without adequate explanations)	Other: no preoperative explanation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative experience evaluated postoperatively using a self-administered questionnaire (EVAN LR)	perioperative experience evaluated postoperatively using a self-administered questionnaire (EVAN LR)	6 days

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: December 5, 2014
• First Posted (Estimate): December 8, 2014

Study Record Updates

• Last Update Posted (Estimate): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 2013-39; RC12_3677 (Registry Identifier: APHM)