BACKGROUND: Meticulous hemostasis is a critical and often time-consuming step of safe thyroid surgery. The LigaSure system (Valleylab, Boulder, CO) is a diathermy hemostasis method that fuses vessel walls to form a collagen seal. Previous studies have shown reduced operative times in thyroidectomy using the LS system. The primary objective of the study was to compare operative times using the LS system to conventional titanium clips and surgical ties (CLTs). Secondary outcomes included vocal cord dysfunction, scores on the Voice Handicap Index (VHI), postoperative hypocalcemia, and operative costs between the two groups. METHODS: Twenty-eight patients were block randomized to thyroidectomy with either the LS system or CLTs. Patient demographics, operative times, pre- and postoperative VHI scores, vocal cord endoscopy, and operative costs were collected on all patients. Patients were also monitored for clinically significant hypocalcemia postoperatively. RESULTS: The mean operative time for CLTs was 68.6 minutes (SD 14.56) versus 68.5 minutes (SD 27.47) for the LS system, which was not statistically significant. VHI scores differed between CLTs and the LS system for the postoperative score only: CLT 19.83 (SD 19.81) versus LS 6.57 (SD 10.83). This was statistically significant, with p = .041. No difference was detected for hypocalcemia rates or endoscopic vocal cord dysfunction. The operative cost for the LS system was $387.15 (SD $11.93) and for the CLTs was $73.60 (SD $27.72), which was statistically significant (p < .001). CONCLUSION: The use of the LS system in thyroidectomy did not reduce overall operative time by a clinically significant level, indicating limited utility in terms of cost reduction contradictory to current literature.
RCT Entities:
BACKGROUND: Meticulous hemostasis is a critical and often time-consuming step of safe thyroid surgery. The LigaSure system (Valleylab, Boulder, CO) is a diathermy hemostasis method that fuses vessel walls to form a collagen seal. Previous studies have shown reduced operative times in thyroidectomy using the LS system. The primary objective of the study was to compare operative times using the LS system to conventional titanium clips and surgical ties (CLTs). Secondary outcomes included vocal cord dysfunction, scores on the Voice Handicap Index (VHI), postoperative hypocalcemia, and operative costs between the two groups. METHODS: Twenty-eight patients were block randomized to thyroidectomy with either the LS system or CLTs. Patient demographics, operative times, pre- and postoperative VHI scores, vocal cord endoscopy, and operative costs were collected on all patients. Patients were also monitored for clinically significant hypocalcemia postoperatively. RESULTS: The mean operative time for CLTs was 68.6 minutes (SD 14.56) versus 68.5 minutes (SD 27.47) for the LS system, which was not statistically significant. VHI scores differed between CLTs and the LS system for the postoperative score only: CLT 19.83 (SD 19.81) versus LS 6.57 (SD 10.83). This was statistically significant, with p = .041. No difference was detected for hypocalcemia rates or endoscopic vocal cord dysfunction. The operative cost for the LS system was $387.15 (SD $11.93) and for the CLTs was $73.60 (SD $27.72), which was statistically significant (p < .001). CONCLUSION: The use of the LS system in thyroidectomy did not reduce overall operative time by a clinically significant level, indicating limited utility in terms of cost reduction contradictory to current literature.
Authors: Pietro Contin; Käthe Gooßen; Kathrin Grummich; Katrin Jensen; Hubertus Schmitz-Winnenthal; Markus W Büchler; Markus K Diener Journal: Langenbecks Arch Surg Date: 2013-11-16 Impact factor: 3.445