Neck Dissection Via a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx

Study Overview
=================
Brief Summary
-----------------
The main hypothesis of this study is that it is possible to make a unilateral selective dissection of ganglion levels IIa, III and IV using an endoscopic transaxillary approach via the da Vinci robotic system to reduce scarring, while respecting patient safety. Feasibility will be assessed by two combinded criteria: 1) performance of the surgical procedure respecting the different stages of visualization and dissection of key anatomical elements; 2) obtain a minimum of 9 lymph nodes when analyzing pathological evidence of the dissection.

Detailed Description
-----------------
Secondary objectives include the following: A. Describe certain technical variables: surgical time, extent of blood loss, need for conversion to open surgery, anesthesia procedure used, the level of difficulty and speed associated with each surgical step, length of stay, B. Describe the pathological findings for each patient, C. Evaluate neurological complications (function of cranial nerve pairs X, XI, XII, brachial plexus, cervical sympathetic) D. Identify specific complications, E. Evaluate post-operative pain, F. Evaluate the scar outcome at 6 and 12 months G. Describe the oncological results at 6 and 12 months.

Official Title
-----------------
Unilateral Selective Neck Dissection at Lymph Node Levels IIa, III and IV Using a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx: the First Three Patients

Conditions
-----------------
Carcinoma, Squamous Cell

Intervention / Treatment
-----------------
* Procedure: Neck Dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer of the epi-larynx: (i) ranked T1 or T2 in the TNM classification, (ii) supraglottic or glotto-supraglottic location, (iii) CN0 nodal status Absence of distant metastasis (M0) Decision for unilateral endoscopic axillary neck dissection at lymph node levels IIa, III and IV of the Robins classification is retained in a multidisciplinary meeting The patient is available for 12 months of follow-up The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan Exclusion Criteria: Patient participating in or having participated in another study within the previous 3 months or currently in an exclusion period determined by a previous study Adult under judicial protection or any kind of guardianship Refusal to sign the consent It is impossible to correctly inform the patient The patient is pregnant, parturient, or breastfeeding Preoperative diagnosis of a second location of cancerous disease Body Mass Index > 25 History of cervical spine surgery History of instability of the cervical spine History of surgery in the shoulder or pre-pectoral region History of ipsilateral neck surgery History of cervical radiotherapy History of breast implants

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 patients cancer of the epi larynx<br>3 patients with squamous cell carcinoma of the epi-larynx Intervention: Neck Dissection | Procedure: Neck Dissection<br>* Unilateral Selective Neck Dissection at Lymph Node Levels IIa, III and IV Using a Robot-assisted Transaxillary Approach. The robotic system used is the da Vinci system.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients that had pre-defined key points of the surgical procedure performed | Were all pre-defined key points of the surgical procedure performed? yes/no Description of the key points (includes (i) axillary approach, (ii) robot arm insertion, (iii) dissection, (iv) closing) of the surgical procedure. | Day 0 | 
| Number of lymph nodes dissected | Determined by analysis of excised tissues. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of surgical site preparation | in minutes | Day 0 | 
| The duration of robot installation / preparation | in minutes | Day O | 
| Intervention time (between incision and closure by the surgeon) | in minutes | Day 0 | 
| Time in general anesthesia | in minutes | Day 0 | 
| Surgical time (console time for robot-assisted surgery) | in minutes | Day 0 | 
| The estimated volume of bleeding | in ml | Day 0 | 
| Need for conversion to open surgery | yes/no | Day 0 | 
| The anesthesia protocol used | Full description. | Day 0 | 
| The level of difficulty associated with each surgical step | Qualitative: easy, medium, hard, extremely hard | Day 0 | 
| The level of speed associated with each surgical step | Qualitative: slow, normal, fast | Day 0 | 
| Length of hospital stay in days |  | estimated max of 6 days | 
| Results of pathological analysis of lymph nodes |  | expected between day 7 and day 15 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Squamous Cell Carcinoma of the Epi-larynx