NCT01752283

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 19, 2012

Completed
Last Updated

December 19, 2012

Status Verified

December 1, 2012

Enrollment Period

1.9 years

First QC Date

October 31, 2012

Last Update Submit

December 18, 2012

Conditions

Surgery

Keywords

VideoassitedThyroidectomyMinimal invasive surgeryGeneral anesthesiaHypnosis

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    To assess technical feasibility

    Intraoperative

Secondary Outcomes (4)

  • Operating time

    during surgery

  • Intraoperative bleeding

    During surgery

  • Conversion to general anesthesia

    During surgery

  • Conversion from video-assisted technique to conventional surgery

    During surgery

Other Outcomes (2)

  • Hemodynamic changes

    During surgery

  • Drug consumption

    During surgery and up to 6 hours after surgery

Study Arms (2)

Hypnosis and local anesthesia

EXPERIMENTAL

video-assisted thyroidectomy under hypnosis and local anesthesia.

Procedure: video-assisted thyroidectomy

General anesthesia

ACTIVE COMPARATOR

Video-assisted thyroidectomy under general anesthesia

Procedure: video-assisted thyroidectomy

Interventions

Video-assisted thyroidectomyPROCEDURE

Experimental arm: video-assisted thyroidectomy under local anesthesia and hypnosis

General anesthesiaHypnosis and local anesthesia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc. 10 Avenue Hippocrate

Brussels, 1200, Belgium

Location

Study Officials

  • Michel Mourad, MD, PhD

    Cliniques Universitaires Saint-Luc. 10 Avenue Hippocrate, 10. 1200 Bruxelles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 31, 2012

First Posted

December 19, 2012

Study Start

January 1, 2010

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

December 19, 2012

Record last verified: 2012-12

Locations

BE(1)