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Video-assisted Thyroid Surgery and Hypnosis in Thyroid Surgery

Primary Purpose

Surgery

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
video-assisted thyroidectomy
Video-assisted thyroidectomy
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring Videoassited, Thyroidectomy, Minimal invasive surgery, General anesthesia, Hypnosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The selection of patients for MIVAT was achieved according to the size of the gland and nodules provided that the cranio-caudal axis of the lobes does not exceed 7 centimeters and the largest transversal diameter is less than 3.5 centimeters
  • Age >18 years

Exclusion Criteria:

  • No previous neck surgery
  • No known malignancy
  • No history of neck irradiation

Sites / Locations

  • Cliniques Universitaires Saint-Luc. 10 Avenue Hippocrate

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypnosis and local anesthesia

General anesthesia

Arm Description

video-assisted thyroidectomy under hypnosis and local anesthesia.

Video-assisted thyroidectomy under general anesthesia

Outcomes

Primary Outcome Measures

Feasibility
To assess technical feasibility

Secondary Outcome Measures

Operating time
Intraoperative bleeding
Conversion to general anesthesia
Conversion from video-assisted technique to conventional surgery

Full Information

First Posted
October 31, 2012
Last Updated
December 18, 2012
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT01752283
Brief Title
Video-assisted Thyroid Surgery and Hypnosis in Thyroid Surgery
Official Title
Combination of Video-assisted Thyroid Surgery and Hypnosis as a Complete Minimally Invasive Approach: a Comparative Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is aimed to investigate the safety and feasibility of Video-assisted thyroidectomy under hypnosis in comparison to general anesthesia
Detailed Description
Summary of the project video-assisted thyroidectomy (MIVAT): General anesthesia (GA) versus hypnosis (HY) Investigators Prof. Michel Mourad*, Dr. Christine Watremez **, Prof. Fabienne Roelants** * Surgery and Abdominal Transplantation Division ** Department of Anesthesiology, Université Catholique de Louvain, Cliniques Universitaires Saint-Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium Aim The aim of this pilot study is to prospectively investigate, in a consecutive series of patients, the feasibility and safety of MIVAT under HY associated with local anesthesia, compared to GA. Inclusion criteria Adult patients candidates to total or partial thyroidectomy. ASA 1, 2 or 3 One surgeon (MM) Informed consent Exclusion criteria Age <18 years The presence of familial medullary thyroid cancers Suspicious or metastatic lymph nodes Redo surgery ASA 4 patients Patients with chronic pain Deaf people Patients with psychiatric diseases Known recurrent nerve paralysis Outcome evaluation Primary outcomes: safety and feasibility. During surgery, considered events for analysis should include operating time (from skin incision to skin closure), total time in the operating room, intraoperative bleeding, drug consumption, Hemodynamic changes and conversion rates from MIVAT to a conventional approach and from HY to GA. After surgery, comparative variables for analysis should include: drug consumption, hospital stay, calcemia, and vocal cord abnormality on the basis of day-one laryngoscopy performed by an ENT doctor not involved in the study. Patients selection and study groups: Selection of patients for MIVAT is based on the size of the gland and nodules, provided that the craniocaudal axis of the lobes did not exceed 7cm and the largest transversal diameter was less than 3.5cm. All patients who are assigned to undergo MIVAT are instructed about the possibility of conversion to a conventional approach. The patients are left free to choose the type of anesthesia they prefere for their surgical intervention. They have to give informed consent before the procedure. A. General anesthesia group: Premedication: Lorazepam 0.5 mg 1 h before surgery ECG, NIBP, SaO2 VVP + NaCl 0.9 % 500 mL + taradyl 0.5 mg / kg (<30 mg) Induction: Remifentanil 0.05 µg/kg/min Propofol 2 mg/kg Intubation with an armored endotracheal tube specially devised for neuromonitoring of the vocal cords. During surgery: Sevoflurane / Remifentanil B. Hypnosis group: Premedication: Lorazepam 0.5 mg 1 h avant l'intervention ECG, NIBP, SaO2 VVP + NaCl 0.9 % 500 mL + taradyl 0.5 mg / kg (< 30 mg) Induction and during surgery: Remifentanil modified as requested Induction of hypnosis according to Milton Eriksson technique Midazolam (titrated 0.1 mg/0.1mg) if needed as anxiolytic. Local anesthesia mixture (lidocaine 0.5%/ropivacaine 0.25%) to be administered by the surgeon along the incision line 5 minutes before making the skin incision.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery
Keywords
Videoassited, Thyroidectomy, Minimal invasive surgery, General anesthesia, Hypnosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis and local anesthesia
Arm Type
Experimental
Arm Description
video-assisted thyroidectomy under hypnosis and local anesthesia.
Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
Video-assisted thyroidectomy under general anesthesia
Intervention Type
Procedure
Intervention Name(s)
video-assisted thyroidectomy
Intervention Description
Experimental arm: video-assisted thyroidectomy under local anesthesia and hypnosis
Intervention Type
Procedure
Intervention Name(s)
Video-assisted thyroidectomy
Intervention Description
video-assisted thyroidectomy under general anesthesia
Primary Outcome Measure Information:
Title
Feasibility
Description
To assess technical feasibility
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Operating time
Time Frame
during surgery
Title
Intraoperative bleeding
Time Frame
During surgery
Title
Conversion to general anesthesia
Time Frame
During surgery
Title
Conversion from video-assisted technique to conventional surgery
Time Frame
During surgery
Other Pre-specified Outcome Measures:
Title
Hemodynamic changes
Time Frame
During surgery
Title
Drug consumption
Time Frame
During surgery and up to 6 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The selection of patients for MIVAT was achieved according to the size of the gland and nodules provided that the cranio-caudal axis of the lobes does not exceed 7 centimeters and the largest transversal diameter is less than 3.5 centimeters Age >18 years Exclusion Criteria: No previous neck surgery No known malignancy No history of neck irradiation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Mourad, MD, PhD
Organizational Affiliation
Cliniques Universitaires Saint-Luc. 10 Avenue Hippocrate, 10. 1200 Bruxelles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc. 10 Avenue Hippocrate
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

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Video-assisted Thyroid Surgery and Hypnosis in Thyroid Surgery

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