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SurgeryNCT01752283

Video-assisted Thyroid Surgery and Hypnosis in Thyroid Surgery

A study testing video-assisted thyroidectomy in people with Surgery, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Surgery
What is being tested?
video-assisted thyroidectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteBelgium
Study dates
Jan 2010to Jun 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Cliniques Universitaires Saint-Luc. 10 Avenue Hippocrate

    Brussels, 1200

Other trials in Belgium

About this study

Official title: Combination of Video-assisted Thyroid Surgery and Hypnosis as a Complete Minimally Invasive Approach: a Comparative Pilot Study

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

Read the 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

  1. 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.
  2. Inclusion criteria
  • Adult patients candidates to total or partial thyroidectomy.
  • ASA 1, 2 or 3
  • One surgeon (MM)
  • Informed consent
  1. 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
  1. 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.
  1. 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.

  1. 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
  1. 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.
Conditions
Surgery
Being tested
video-assisted thyroidectomy
Keywords
Videoassited, Thyroidectomy, Minimal invasive surgery, General anesthesia, Hypnosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • video-assisted thyroidectomyProcedure or surgery

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

  • Video-assisted thyroidectomyProcedure or surgery

    video-assisted thyroidectomy under general anesthesia

Study groups in NCT01752283
Study groupRoleWhat they receive
Hypnosis and local anesthesiaExperimentalvideo-assisted thyroidectomy under hypnosis and local anesthesia.
Receives: Procedure: video-assisted thyroidectomy
General anesthesiaActive comparatorVideo-assisted thyroidectomy under general anesthesia
Receives: Procedure: video-assisted thyroidectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility

    To assess technical feasibility

    Measured: Intraoperative

Secondary outcomes (4)
  1. Operating time

    Measured: during surgery

  2. Intraoperative bleeding

    Measured: During surgery

  3. Conversion to general anesthesia

    Measured: During surgery

  4. Conversion from video-assisted technique to conventional surgery

    Measured: During surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2012 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2011
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01752283
Sponsor's protocol ID
Video-Hypnose
Status last verified
Dec 2012
First submitted
31 Oct 2012
Last updated
19 Dec 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing video-assisted thyroidectomy in people with Surgery, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (time frame: Intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2012.

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