K Verónica Chavez1, E Manuel Barajas1, Jaqueline Ramírez2, Juan Pablo Pantoja1, Mauricio Sierra1, David Velázquez-Fernandez1, Miguel F Herrera3. 1. Service of Endocrine Surgery, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, México City, México. 2. Otolaryngology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, México City, México. 3. Service of Endocrine Surgery, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, México City, México. Electronic address: miguelfherrera@gmail.com.
Abstract
BACKGROUND: Advanced bipolar and ultrasonic devices have shown significant reduction in the surgical time of thyroid operations. This randomized, controlled trial assessed if operative time and other relevant outcomes are different for thyroidectomies performed either with a second-generation advanced bipolar device or traditional tie and suture technique. METHODS: Forty-one patients were randomized into 2 groups (advanced bipolar device and traditional tie and suture). Secondary end points included estimated blood loss, postoperative hemorrhage or hematoma requiring operative reintervention, recurrent laryngeal nerve injury, hypoparathyroidism, pain intensity, number of ligatures, analgesia usage, and loss of signal during recurrent laryngeal nerve monitoring. RESULTS: Preoperative characteristics were similar between both groups. Mean operative time in the advanced bipolar device group was reduced by 32.5 minutes compared with the traditional tie and suture group (P = .006). Intraoperative blood loss was similar in both groups. Four patients presented postoperative vocal cord dysmotility, 3 in the traditional tie and suture group and 1 in the advanced bipolar device group (P = ns). Two of these 4 patients also had a >50% amplitude decrease during continuous intraoperative neuromonitoring, 1 in each group. Pain intensity, 12 hours after operation, was significantly greater in the traditional tie and suture group (P = .015), even though pain medication requirements during the initial 24 hours after operation were similar between groups (P = .97). There were no cases of postoperative hemorrhage or hematoma requiring reintervention. Postoperative, symptomatic hypocalcemia occurred in 6 patients, 4 in the traditional tie and suture, and 2 in the advanced bipolar device group. One of them developed permanent hypocalcemia. CONCLUSION: The use of an advanced bipolar device in thyroid operation reduces operative time by >30 minutes, with a similar postoperative outcome profile when compared with the traditional tie and suture technique.
RCT Entities:
BACKGROUND: Advanced bipolar and ultrasonic devices have shown significant reduction in the surgical time of thyroid operations. This randomized, controlled trial assessed if operative time and other relevant outcomes are different for thyroidectomies performed either with a second-generation advanced bipolar device or traditional tie and suture technique. METHODS: Forty-one patients were randomized into 2 groups (advanced bipolar device and traditional tie and suture). Secondary end points included estimated blood loss, postoperative hemorrhage or hematoma requiring operative reintervention, recurrent laryngeal nerve injury, hypoparathyroidism, pain intensity, number of ligatures, analgesia usage, and loss of signal during recurrent laryngeal nerve monitoring. RESULTS: Preoperative characteristics were similar between both groups. Mean operative time in the advanced bipolar device group was reduced by 32.5 minutes compared with the traditional tie and suture group (P = .006). Intraoperative blood loss was similar in both groups. Four patients presented postoperative vocal cord dysmotility, 3 in the traditional tie and suture group and 1 in the advanced bipolar device group (P = ns). Two of these 4 patients also had a >50% amplitude decrease during continuous intraoperative neuromonitoring, 1 in each group. Pain intensity, 12 hours after operation, was significantly greater in the traditional tie and suture group (P = .015), even though pain medication requirements during the initial 24 hours after operation were similar between groups (P = .97). There were no cases of postoperative hemorrhage or hematoma requiring reintervention. Postoperative, symptomatic hypocalcemia occurred in 6 patients, 4 in the traditional tie and suture, and 2 in the advanced bipolar device group. One of them developed permanent hypocalcemia. CONCLUSION: The use of an advanced bipolar device in thyroid operation reduces operative time by >30 minutes, with a similar postoperative outcome profile when compared with the traditional tie and suture technique.