The objective of this study is to compare shoulder and neck morbidity and the effectiveness of cervical lateral nodal dissection in patients with differentiated thyroid cancer and lateral metastases between the anterior and posterior approaches to the sternocleidomastoid muscle (SCM)
Patients ≥ 18 years.
Patients with macroscopic lymph node involvement identified by physical examination, imaging or intraoperatively in lateral neck.
Patients with microscopic nodal involvement confirmed by FNAB (definition by the pathologist of suspected or confirmed metastatic papillary carcinoma according to the Bethesda criteria)
Candidates for lateral lymph node dissection due to suspected or confirmed disease metastatic lymph nodes as defined by the treating surgeon.
Patients with a history of previous neck dissection
Histological confirmation of medullary or anaplastic carcinoma
Previous spinal nerve injury
Parallel
Traditional neck dissection approach
Procedure/Surgery.1. A transverse cervical incision is made with horizontal extension towards the affected side. 2. It is dissected through the subplatysmal plane, the posterior edge of the sternocleidomastoid muscle is dissected along its entire length. 3. Identification and dissection of the spinal nerve at Erb's point. 4. Level V nodes are dissected up to the spinal nerve without identifying or dissecting it 5. The jugular chain nodes are identified and the left level IV nodes are dissected with special attention to ligate the lymphatics of this level 6. Identification and dissection of level III nodes 7. Identification and dissection of level IIA and IIB ganglia with identification and preservation of the accessory nerve.
Anterior neck dissection approach
Procedure/Surgery1. A transverse cervical incision is made with horizontal extension towards the affected side. 2. It is dissected through the subplatysmal plane, the anterior edge of the sternocleidomastoid muscle is dissected along its entire length. 3. Level V nodes are dissected up to the spinal nerve without identifying or dissecting it 4. The jugular chain nodes are identified and the left level IV nodes are dissected with special attention to ligate the lymphatics of this level 5. Identification and dissection of level III nodes 6. Identification and dissection of level IIA and IIB nodes with identification and preservation of the accessory nerve.
Shoulder dysfunction
(SPADI shoulder pain and disability questionnaire, validated in Spanish) Minimun score 0, maximun 100, a higher score means higher disability
Cervical disconfort
The Cervical Disability Index (IDC) validated in Spanish Minimun score 0, maximun 50, a higher score means higher disability
Complications
Temporary or permanent accessory nerve injury measured in the physical examination by limitation of the lateral range of movement of the shoulder less than 50% * Bleeding defined by the treating surgeon by physical examination * Wound infection: infection in the first 30 days after surgery, diagnosed with at least one of the following criteria: presence of purulent discharge from the surgical wound, presence of microorganisms isolated by taking a culture of wound discharge , presence of at least one of the signs and symptoms of inflammation (pain, redness, edema, heat). * Chylous fistula defined as milky discharge from the cervical drain with a triglyceride count higher than the serum. * Mortality * Re Operation before 30 days
Total lymph node count.
Total number of resected and compromised lymph nodes according to the histopathology report
Surgical time
Surgical time in minutes according to the surgical report
Lateral lymph node recurrence
Number of participants with presence of tumor in the neck lymph nodes detected during follow-up by physical examination or imaging 6 months or more after primary surgery and confirmed cytopathologically.
Dynamic response
Number of participants with excellent, incomplete biochemical, incomplete structural or undetermined response according to the ATA classification.
Click on the lead sponsor to view all of their trials.
Centro de Excelencia en Enfermedades de Cabeza y Cuello
Lead sponsor
Hospital Alma Mater de Antioquia
Collaborator
Hospital San Vicente Fundación
Collaborator
Clinica Las Vegas- Grupo QuironSalud
Collaborator
