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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014