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Video-assisted Thyroid Surgery and Hypnosis in Thyroid Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mourad, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01752283
First received: October 31, 2012
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Surgery
 Procedure: video-assisted thyroidectomy
Procedure: Video-assisted thyroidectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid
U.S. FDA Resources

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Feasibility [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]
    To assess technical feasibility


Secondary Outcome Measures:
  • Operating time [ Time Frame: during surgery ] [ Designated as safety issue: Yes ]
  • Intraoperative bleeding [ Time Frame: During surgery ] [ Designated as safety issue: Yes ]
  • Conversion to general anesthesia [ Time Frame: During surgery ] [ Designated as safety issue: Yes ]
  • Conversion from video-assisted technique to conventional surgery [ Time Frame: During surgery ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Hemodynamic changes [ Time Frame: During surgery ] [ Designated as safety issue: Yes ]
  • Drug consumption [ Time Frame: During surgery and up to 6 hours after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 130
Study Start Date: January 2010
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: October 31, 2012
Last Updated: December 18, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by 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
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013