Prospective randomized trial of ligasure versus harmonic hemostasis technique in thyroidectomy.
ABSTRACT Two surgical devices have become popular in thyroid surgery: a bipolar energy sealing system (B) and ultrasonic coagulation (UC). Retrospective and prospective studies have demonstrated that the use of these surgical devices for thyroidectomy compared with conventional thyroidectomy (clamp-and-tie) techniques reduces operative time and cost. We conducted a prospective randomized clinical trial to determine if there is any difference in operative time and cost between B and UC.
A single-blinded prospective randomized controlled trial was conducted at a tertiary referral center. A total of 90 patients who required a thyroidectomy for thyroid cancer, thyroid nodules, or hyperthyroidism were randomized to either B or UC during thyroidectomy. The operative time and cost of thyroidectomy were compared between the two groups.
There was no statistically significant difference in patient age, gender, body mass index, indication for thyroidectomy and thyroid gland weight between the two groups. There was no statistically significant difference in operating room cost or total cost for thyroidectomy between the B and UC groups. There was also no statistically significant difference in the operative time between the B and UC groups (187.6 vs. 184.2 min, P = 0.48) or in postoperative complication rates. The only statistically significant difference in total cost was between surgeons independent of the device used (P < 0.01).
In thyroid surgery, total cost and operative time were similar between the two surgical devices used.
- SourceAvailable from: Kathrin Grummich
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- "31 vs. 31 vs. 31 51 74 B Total Rahbari 2011  45 vs. 45 47 80 B and M Total and partial+CND Dionigi 2012  "
ABSTRACT: Energized vessel-sealing systems have been proposed to save operation time and reduce post-operative complications. The aim of the present systematic review was to compare operation time and postoperative morbidity for ultrasonic and electrothermal bipolar-activated devices with conventional hemostasis techniques and with each other in open thyroidectomy. A systematic literature search (MEDLINE, Cochrane Library, EMBASE and ISI Web of Science) was performed to identify randomised controlled trials (RCTs) comparing conventional hemostasis techniques, ultrasonic devices (Harmonic® scalpel) and/or electrothermal bipolar-activated vessel sealing systems (Ligasure®) during open thyroidectomy. For the primary endpoint (operation time), a network meta-analysis with Bayesian random effects model was performed. Pairwise meta-analyses with random effects were calculated for primary and secondary endpoints. One hundred sixteen publications were evaluated for eligibility; 35 RCTs (4,061 patients) were included. There was considerable methodological and clinical heterogeneity of included trials. The Harmonic scalpel significantly reduced operation time compared with conventional techniques (22.26 min, 22.7 min in the inconsistency model). The use of Ligasure significantly reduced operation time in total thyroidectomy (13.84 min in the consistency model, 12.18 min in the inconsistency model). In direct comparison, operations with the Harmonic scalpel were faster than with Ligasure (8.42 min in the consistency model, 2.45 min in the inconsistency model). The rates of recurrent nerve palsy and postoperative hypocalcaemia did not significantly differ in the intervention groups. This meta-analysis shows superiority of ultrasonic devices in terms of operation time compared with conventional hemostasis techniques in thyroid surgery, with no detriment to safety outcomes.Langenbeck s Archives of Surgery 11/2013; 398(8). DOI:10.1007/s00423-013-1137-7 · 2.16 Impact Factor
European Annals of Otorhinolaryngology, Head and Neck Diseases 06/2011; 128(4):200-2. DOI:10.1016/j.anorl.2011.02.015
- "According to these three meta-analyses, the Ligasure ® device decreases postoperative pain, but without decreasing hypocalcaemia or blood loss . Two prospective, randomized studies compared the two technologies  . Pons et al. demonstrated a significant 8-minute reduction of operating time with the Harmonic ® device compared to the Ligasure device (P = 0.04). "
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ABSTRACT: Aim: Thyroidectomy is a surgical procedure that requires meticulous dissection, safe anatomical exposure and effective haemostasis. The aim of the present study is to compare the use of the harmonic scalpel with conventional haemostatic techniques in patients with benign thyroid enlargement undergoing total thyroidectomy Method: Consecutive patients treated for thyroid enlargement at our institution were evaluated for inclusion. Participants were randomly allocated to receive total thyroidectomy using harmonic scalpel (HS) or using ligature conventional thyroidectomy (CT), Study variables included operative time, length of incision, operative bleeding, postoperative drainage, hospital stay and complication. Results: one hundred and thirty patients with benign thyroid enlargement were randomized and completed the study. The mean incision length was 5.14±1.13 cm (4 -7 cm) in HS group and 8.78±1.4 cm (6-11 cm) in CT group p=0.04. Operative time was 50.27 ± 8.03 minutes for HS and 102.38 ± 14.63 minutes for CT (p=0.001). There was a significant difference in intraoperative bleeding and postoperative drainage between the two groups. Five patients (7.7%) in CT group and two patients (3.15%) in HS group experienced transient recurrent laryngeal nerve palsy (p= 0.24) .Two patients (3.15%) in HS group suffered from manifested hypocalcaemia and six patients (9.2%) in CT groups. Conclusion: HS is a safe, easier and effective alternative to knot tying technique for total thyroidectomy, allowing for a significant reduction of operative time, shorter incision, less intraoperative bleeding, less postoperative drainage without increasing complication rate.