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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
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.
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
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.
Time frame: Day 0
Number of lymph nodes dissected
Determined by analysis of excised tissues.
Time frame: Day 0
The duration of surgical site preparation
in minutes
Time frame: Day 0
The duration of robot installation / preparation
in minutes
Time frame: Day O
Intervention time (between incision and closure by the surgeon)
in minutes
Time frame: Day 0
Time in general anesthesia
in minutes
Time frame: Day 0
Surgical time (console time for robot-assisted surgery)
in minutes
Time frame: Day 0
The estimated volume of bleeding
in ml
Time frame: Day 0
Need for conversion to open surgery
yes/no
Time frame: Day 0
The anesthesia protocol used
Full description.
Time frame: Day 0
The level of difficulty associated with each surgical step
Qualitative: easy, medium, hard, extremely hard
Time frame: Day 0
The level of speed associated with each surgical step
Qualitative: slow, normal, fast
Time frame: Day 0
Length of hospital stay in days
Time frame: estimated max of 6 days
Results of pathological analysis of lymph nodes
Time frame: expected between day 7 and day 15
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