Alvaro Sanabria1,2,3,4,5, Carlos Betancourt-Agüero1,3,4,5, Juan G Sánchez-Delgado1,2,3,4,5, Carlos García-Lozano1,2,3,4,5. 1. Department of Surgery, School of Medicine, Universidad de Antioquia, Medellín, Colombia. 2. Head and Neck Service, IPS Universitaria - Clínica Leon XIII, Medellín, Colombia. 3. Head and Neck Service, Hospital Universitario San Vicente Fundacion, Medellín, Colombia. 4. Head and Neck Service, Clínica Las Vegas - Grupo Quironsalud, Medellín, Colombia. 5. CEXCA Centro de Excelencia en Enfermedades de Cabeza y Cuello, Medellín, Colombia.
Abstract
OBJECTIVE: To evaluate the effectiveness of T + prophylactic CND (T+CND) compared to T alone on locoregional recurrence in patients with PTC. SUMMARY BACKGROUND DATA: Few RCTs have assessed the risks and benefits of prophylactic CND in patients with PTC. Most recommendations are still based on meta-analyses that include observational studies, which are prone to selection bias. METHODS: We included RCTs involving adult patients with clinically negative neck (cN0) PTC that compared T versus T+CND. The main outcomes assessed were structural and biochemical recurrence and complications. For methodological quality assessment, we used the Revised Cochrane risk-of-bias tool for randomized trials instrument, and for robustness, we used the fragility index. RESULTS: Five RCTs with 763 patients were included (354 in the T group and 409 in the T+CND group). Most studies were classified as having a low risk of bias. Publication bias was not found. Structural recurrence occurred in 11/409 (2.7%) patients in the T+CND group and 9/354 (2.5%) patients in the T group, with a risk difference (RD) =0% [95% confidence interval (CI) -2% to 2%]. For biochemical recurrence, the RD was 0% (95% CI -5% to 4%). The number needed to treat was 500. The rate of permanent hypoparathyroidism was higher in the T+CND group than in the T group [RD 3% (95% CI 0%-6%)]. CONCLUSIONS: We did not find a beneficial effect of prophylactic CND associated with T on locoregional or biochemical recurrence but did confirm a higher risk of permanent hypoparathyroidism associated with this procedure.
OBJECTIVE: To evaluate the effectiveness of T + prophylactic CND (T+CND) compared to T alone on locoregional recurrence in patients with PTC. SUMMARY BACKGROUND DATA: Few RCTs have assessed the risks and benefits of prophylactic CND in patients with PTC. Most recommendations are still based on meta-analyses that include observational studies, which are prone to selection bias. METHODS: We included RCTs involving adult patients with clinically negative neck (cN0) PTC that compared T versus T+CND. The main outcomes assessed were structural and biochemical recurrence and complications. For methodological quality assessment, we used the Revised Cochrane risk-of-bias tool for randomized trials instrument, and for robustness, we used the fragility index. RESULTS: Five RCTs with 763 patients were included (354 in the T group and 409 in the T+CND group). Most studies were classified as having a low risk of bias. Publication bias was not found. Structural recurrence occurred in 11/409 (2.7%) patients in the T+CND group and 9/354 (2.5%) patients in the T group, with a risk difference (RD) =0% [95% confidence interval (CI) -2% to 2%]. For biochemical recurrence, the RD was 0% (95% CI -5% to 4%). The number needed to treat was 500. The rate of permanent hypoparathyroidism was higher in the T+CND group than in the T group [RD 3% (95% CI 0%-6%)]. CONCLUSIONS: We did not find a beneficial effect of prophylactic CND associated with T on locoregional or biochemical recurrence but did confirm a higher risk of permanent hypoparathyroidism associated with this procedure.