Neck Dissection Via a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx
- Conditions
- Carcinoma, Squamous Cell
- Interventions
- Procedure: Neck Dissection
- Registration Number
- NCT02269020
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 3 patients cancer of the epi larynx Neck Dissection 3 patients with squamous cell carcinoma of the epi-larynx Intervention: Neck Dissection
- Primary Outcome Measures
Name Time Method Number of patients that had pre-defined key points of the surgical procedure performed Day 0 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.
Number of lymph nodes dissected Day 0 Determined by analysis of excised tissues.
- Secondary Outcome Measures
Name Time Method The duration of robot installation / preparation Day O in minutes
Intervention time (between incision and closure by the surgeon) Day 0 in minutes
Time in general anesthesia Day 0 in minutes
The level of difficulty associated with each surgical step Day 0 Qualitative: easy, medium, hard, extremely hard
Results of pathological analysis of lymph nodes expected between day 7 and day 15 The duration of surgical site preparation Day 0 in minutes
Surgical time (console time for robot-assisted surgery) Day 0 in minutes
Need for conversion to open surgery Day 0 yes/no
Length of hospital stay in days estimated max of 6 days The estimated volume of bleeding Day 0 in ml
The anesthesia protocol used Day 0 Full description.
The level of speed associated with each surgical step Day 0 Qualitative: slow, normal, fast
Trial Locations
- Locations (1)
CHRU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, France