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.
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
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
- 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.
- Inclusion criteria
- Adult patients candidates to total or partial thyroidectomy.
- ASA 1, 2 or 3
- One surgeon (MM)
- Informed consent
- 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
- 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.
- 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.
- 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
- 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 group | Role | What they receive |
|---|---|---|
| Hypnosis and local anesthesia | Experimental | video-assisted thyroidectomy under hypnosis and local anesthesia. Receives: Procedure: video-assisted thyroidectomy |
| General anesthesia | Active comparator | Video-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.
Feasibility
To assess technical feasibility
Measured: Intraoperative
Secondary outcomes (4)
Operating time
Measured: during surgery
Intraoperative bleeding
Measured: During surgery
Conversion to general anesthesia
Measured: During surgery
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.
- First posted19 Dec 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mourad, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Michel Mourad, MD, PhD, Principal investigator, Cliniques Universitaires Saint-Luc. 10 Avenue Hippocrate, 10. 1200 Bruxelles
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Video-assisted Thyroid Surgery and Hypnosis as a Complete Minimally Invasive Approach: a Comparative Pilot Study
- ClinicalTrials.gov ID
- NCT01752283
- Acronym / sponsor ID
- Video-Hypnose
- Conditions
- Surgery
- Keywords
- Videoassited, Thyroidectomy, Minimal invasive surgery, General anesthesia, Hypnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is aimed to investigate the safety and feasibility of Video-assisted thyroidectomy under hypnosis in comparison to general anesthesia
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
- 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.
- Inclusion criteria
- Adult patients candidates to total or partial thyroidectomy.
- ASA 1, 2 or 3
- One surgeon (MM)
- Informed consent
- 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
- 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.
- 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.
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis and local anesthesia | Experimental | Procedure: video-assisted thyroidectomyvideo-assisted thyroidectomy under hypnosis and local anesthesia. |
| General anesthesia | Active comparator | Procedure: video-assisted thyroidectomyVideo-assisted thyroidectomy under general anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- No previous neck surgery
- No known malignancy
- No history of neck irradiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video-assisted thyroidectomyExperimental arm: video-assisted thyroidectomy under local anesthesia and hypnosis | Procedure or surgery | General anesthesia, Hypnosis and local anesthesia |
| Video-assisted thyroidectomyvideo-assisted thyroidectomy under general anesthesia | Procedure or surgery | General anesthesia, Hypnosis and local anesthesia |
Primary outcome
Feasibility
Time frame: Intraoperative
To assess technical feasibility
4 secondary outcomes
Operating time
Time frame: during surgery
Intraoperative bleeding
Time frame: During surgery
Conversion to general anesthesia
Time frame: During surgery
Conversion from video-assisted technique to conventional surgery
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Mourad, MD, PhD principal investigator
Cliniques Universitaires Saint-Luc. 10 Avenue Hippocrate, 10. 1200 Bruxelles
1 site in 1 country: see every site and its status.
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.