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Video-assisted Thyroid Surgery and Hypnosis in Thyroid Surgery

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ClinicalTrials.gov Identifier: NCT01752283
Recruitment Status : Completed
First Posted : December 19, 2012
Last Update Posted : December 19, 2012
Sponsor:
Information provided by (Responsible Party):
Mourad, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:
The study is aimed to investigate the safety and feasibility of Video-assisted thyroidectomy under hypnosis in comparison to general anesthesia

Condition or disease Intervention/treatment Phase
Surgery Procedure: video-assisted thyroidectomy Procedure: Video-assisted thyroidectomy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination of Video-assisted Thyroid Surgery and Hypnosis as a Complete Minimally Invasive Approach: a Comparative Pilot Study
Study Start Date : January 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Hypnosis and local anesthesia
video-assisted thyroidectomy under hypnosis and local anesthesia.
Procedure: video-assisted thyroidectomy
Experimental arm: video-assisted thyroidectomy under local anesthesia and hypnosis
Procedure: Video-assisted thyroidectomy
video-assisted thyroidectomy under general anesthesia
Active Comparator: General anesthesia
Video-assisted thyroidectomy under general anesthesia
Procedure: video-assisted thyroidectomy
Experimental arm: video-assisted thyroidectomy under local anesthesia and hypnosis
Procedure: Video-assisted thyroidectomy
video-assisted thyroidectomy under general anesthesia



Primary Outcome Measures :
  1. Feasibility [ Time Frame: Intraoperative ]
    To assess technical feasibility


Secondary Outcome Measures :
  1. Operating time [ Time Frame: during surgery ]
  2. Intraoperative bleeding [ Time Frame: During surgery ]
  3. Conversion to general anesthesia [ Time Frame: During surgery ]
  4. Conversion from video-assisted technique to conventional surgery [ Time Frame: During surgery ]

Other Outcome Measures:
  1. Hemodynamic changes [ Time Frame: During surgery ]
  2. Drug consumption [ Time Frame: During surgery and up to 6 hours after surgery ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752283


Locations
Belgium
Cliniques Universitaires Saint-Luc. 10 Avenue Hippocrate
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Michel Mourad, MD, PhD Cliniques Universitaires Saint-Luc. 10 Avenue Hippocrate, 10. 1200 Bruxelles

Responsible Party: Mourad, MD, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01752283     History of Changes
Other Study ID Numbers: Video-Hypnose
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: December 19, 2012
Last Verified: December 2012

Keywords provided by Mourad, Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Videoassited
Thyroidectomy
Minimal invasive surgery
General anesthesia
Hypnosis

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs