Prospective Study Assessing Thyroidectomy Using Robot

NCT ID: NCT02839655

Last Updated: 2018-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2022-08-31

Brief Summary

The robot-assisted surgery for benign and malignant thyroid tumors was widely developed in Asia and begins to spread in Western countries. The main advantage of the technique is to avoid a scar in the neck by placing it either in the axilla or at the hairline behind the ear to improve esthetic consequences and body image. It is not surgery minimally invasive but rather a way of remote access surgery.

Data from the literature including cohort studies and meta-analyzes attest the security of the procedure in comparison with classic thyroid surgery (which remains the "gold standard"). However there is few data on the effectiveness of the technique in terms of the completeness of the surgery, according to the routine standard criteria used in endocrinology and endocrine cancer, and no French medico-economic study has been performed.

Conditions

Patients With Thyroid Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Da Vinci Xi

Group Type: EXPERIMENTAL

Da Vinci Xi

Intervention Type: DEVICE

Interventions

Da Vinci Xi

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Benign thyroid nodule or follicular or suspicious cytological (Bethesda classifications 2, 3, 4, or 5) requiring thyroid lobectomy or total thyroidectomy therapeutic or diagnostic

2. Differentiated thyroid cancers - CN0 (no suspicious lymph node in the central or lateral compartments on preoperative ultrasound - CN1A / b with lymph node metastases <or = 10 mm in areas VI, III and / or IV, detected on preoperative ultrasound - For which the indication of a lobectomy or total thyroidectomy, with or without dissection of the central compartment and / or lateral neck was put in multidisciplinary meeting

3. Patient with no cons-indication to thyroid surgery or without dissection

4. Patient general condition of WHO grade 0-1

5. Patient age > 18 years and able to comply with the protocol visits

6. Patient agreeing to undergo robot-assisted surgery, the incision being at patient choice, depending on the wishes concerning the location of the scar (Axillary or behind the ear channel)

7. Patient Information or his legal representative and signed consent enlightened

8. Patient affiliated to a system of social security or beneficiary of such a scheme

Exclusion Criteria

1. A history of cervical surgery or external beam radiation therapy

2. Anomaly craniocervical hinge or symptomatic cervical spondylosis

3. Congenital or acquired shoulder or ipsilateral upper limb surgery (for axillary )

4. paralysis preoperatively ( a laryngoscopic examination will be performed systematically preoperatively )

5. tumors with obvious extra- thyroid extension or suspected during preoperative ( cT3T4 )

6. metastatic cervical lymphadenopathy > 10 mm during the preoperative

7. Pregnant women or during lactation

8. patient already included in another clinical trial with a molecule experimental

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gustave Roussy

Villejuif, Val De Marne, France

Countries

France

Other Identifiers

2015/2273

Identifier Type: OTHER

Identifier Source: secondary_id

2015-A00989-40

Identifier Type: -

Identifier Source: org_study_id