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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00117-40 | Other Identifier | RCB number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 patients cancer of the epi larynx | Experimental | 3 patients with squamous cell carcinoma of the epi-larynx Intervention: Neck Dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neck Dissection | Procedure | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The duration of surgical site preparation | in minutes | Day 0 |
| The duration of robot installation / preparation | in minutes | Day O |
| Measure | Description | Time Frame |
|---|---|---|
| The number of ganglions excised at each level. | expected between day 7 and day 15 | |
| The number of metastatic ganglions | expected between day 7 and day 15 | |
| The presence/absence of capsular rupture |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Lallemant, MD, PhD | Centre Hospitalier Universitaire de NÄ«mes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
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| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D037981 | Neck Dissection |
| ID | Term |
|---|---|
| D008197 | Lymph Node Excision |
| D013514 | Surgical Procedures, Operative |
| D013517 | Otorhinolaryngologic Surgical Procedures |
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| 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 |
| expected between day 7 and day 15 |
| Normal functioning of cranial nerve IX: yes/no. | Day 15 |
| Normal functioning of cranial nerve X: yes/no. | Day 15 |
| Normal functioning of cranial nerve XI: yes/no. | Day 15 |
| Normal functioning of cranial nerve XII: yes/no. | Day 15 |
| Normal functioning of the brachial plexus nerve: yes/no. | Day 15 |
| Normal functioning of the cervical sympathetic nerve: yes/no. | Day 15 |
| Normal functioning of cranial nerve IX: yes/no. | Month 6 |
| Normal functioning of cranial nerve X: yes/no. | Month 6 |
| Normal functioning of cranial nerve XI: yes/no. | Month 6 |
| Normal functioning of cranial nerve XII: yes/no. | Month 6 |
| Normal functioning of the brachial plexus nerve: yes/no. | Month 6 |
| Normal functioning of the cervial sympathetic nerve: yes/no. | Month 6 |
| Normal functioning of cranial nerve IX: yes/no. | Month 12 |
| Normal functioning of cranial nerve X: yes/no. | Month 12 |
| Normal functioning of cranial nerve XI: yes/no. | Month 12 |
| Normal functioning of cranial nerve XII: yes/no. | Month 12 |
| Normal functioning of the brachial plexus nerve: yes/no. | Month 12 |
| Normal functioning of the cervical sympathetic nerve: yes/no. | Month 12 |
| Presence/absence of intraoperative complications | Day 0 |
| Presence / absence of complications during the hospitalization period | estimated max of 6 days |
| Presence / absence of complications at the post-operative follow-up visit | day 7 to day 15 |
| Analgesic consumption | Qualitative: Level I, Level II, Level III. | During hospitalization; expected max of 6 days |
| Analgesic consumption | Qualitative: Level I, Level II, Level III. | days 7 to 15 |
| Analgesic consumption | Qualitative: Level I, Level II, Level III. | month 6 |
| Daily visual analog scale for pain | During hospitalization; expected max of 6 days. |
| Visual analog scale for pain | days 7 to 15 |
| Visual analog scale for pain | month 6 |
| Visual analog scale for pain | month 12 |
| Length of axillary scar | day 0 |
| Length of thoracic scar | day 0 |
| Length of axillary scar | month 6 |
| Length of thoracic scar | month 6 |
| Length of axillary scar | month 12 |
| Length of thoracic scar | month 12 |
| Patient satisfaction concerning his/her scar | visual analog scale from 0 to 10 | month 6 |
| Patient satisfaction concerning his/her scar | visual analog scale from 0 to 10 | month 12 |
| Oncological results | Qualitative variable: (A) Living with disease progression, if so: (i) Recurrence: yes / no; (ii) Metastases: yes / no. or (B) Living without recurrence or (C) Deceased; give causes. | month 6 |
| Oncological results | Qualitative variable: (A) Living with disease progression, if so: (i) Recurrence: yes / no; (ii) Metastases: yes / no. or (B) Living without recurrence or (C) Deceased; give causes. | month 12 |
| D018307 |
| Neoplasms, Squamous Cell |