- Open Access
Randomized clinical trial of LigaSure versus conventional suture ligation in thyroid surgery
© Schiphorst et al; licensee BioMed Central Ltd. 2012
- Received: 27 December 2011
- Accepted: 18 January 2012
- Published: 18 January 2012
In thyroid surgery vessel division and haemostasis make up an important and time consuming part of the operation. While the presence of the recurrent laryngeal nerve limits the liberal use of diathermia, the many arterial and venous branches to and from the thyroid gland necessitates the use of numerous conventional suture ligatures.This study evaluates the effect of using a vessel sealing system on operation time during thyroid surgery.
A randomized clinical trial was performed between September 2005 and October 2008 in a teaching hospital. Forty patients undergoing total hemithyroidectomy participated in the trial. Twenty were randomized to the intraoperative use of the LigaSure Precise™ vessel sealing system, and twenty to the use of conventional suture ligatures.
The total median operation time was 10 minutes shorter in the LigaSure group (56 versus 66 minutes, P = 0.001). No significant differences in complications were noticed.
Using an electrothermal vessel sealing system during thyroid surgery is time saving.
This trial was registered in the international standard randomized controlled trials number register (ISRCTNR) under number ISRCTNR82389535.
- Operative Surgical Procedures
- Thyroid surgery
- Suture ligation
- Operation time
In thyroid surgery vessel division and haemostasis make up an important and time consuming part of the operation. While the presence of the recurrent laryngeal nerve limits the liberal use of diathermia, the calibre of many arterial and venous branches to and from the thyroid gland necessitates the use of numerous conventional suture ligatures.
Electrothermal bipolar vessel sealing (LigaSure) has proven to be safe and effective for "sealing" medium-sized vessels. A clinically relevant decrease of operative time has been shown in abdominal surgery as well as for haemorrhoidectomy [1–3].
We conducted a randomized trial to assess the effect of LigaSure on operation time in thyroid surgery.
Patients were unaware of allocation to either intraoperative use of the LigaSure Precise™ vessel sealing system (Valleylab, Tyco Healthcare, Boulder, Colorado, USA) or conventional suture ligatures. Randomization was done by shuffled sealed envelopes, opened by the surgeon at the start of anaesthesia. The use of diathermia for smaller vessels was allowed in both treatment arms. No surgical clips or other haemostatic aids were used in either group. All operations were performed by a surgical resident and the senior author (ThvD).
Three phases in the operative procedure were defined:
I, Kochers skin incision, separation and undermining of the strap muscles, sealing of middle thyroid veins
II, ligation of the upper thyroid pole vessels and the ima veins, dissection of the lateral part of the gland to the isthmus and cleavage of the gland in the midline
III, haemostasis and closure.
The total operation time measured from the time of incision to the moment of skin closure was the primary endpoint of the study. The duration of the different phases of the operation, the number of sealed or ligated vessels, and postoperative complications (bleeding necessitating re-operation and recurrent laryngeal nerve palsy) were secondary endpoints.
Chi-square and Mann-Whitney U tests were performed to test differences between the groups (SPSS 11 (SPSS, Chicago, IL)). All tests were 2-sided with a 0.05 cut-off for statistical significance. Sample size was determined with PASS Power analysis software (NCSS, Kaysville, Utah, USA) using simulation; the study had a power of 0.85 to detect a 15 minutes difference in median total operation time given a 2-sided alpha of 0.05.
(n = 20)
(n = 20)
Age (yrs); median (range)
Gender (male vs female)
Indication for operation (n)
Suspicion of malignancy
Operated by resident as first surgeon (%)
Operation time, number of ligated vessels and complications in the LigaSure and conventional ligation Group.
(n = 20)
(n = 20)
Total operation time (min); median (range)
Length of operation phases (min); median (range)
Operation phase I
Operation phase II
Operation phase III
Number of ligated vessels; median (range)
Operation phase I
Operation phase II
Operation phase III
Number of patients with complicated postoperative course
No patient needed a reoperation for postoperative haemorrhage. Two patients in the LigaSure group suffered from transient recurrent laryngeal nerve palsy that resolved spontaneously in both patients after six and seven weeks respectively. This difference was not significant.
In this randomized trial a significant time saving effect of the LigaSure vessel sealing system was observed in thyroid surgery. A median 10 minutes were gained during hemithyroidectomy. As most of the time was saved during the actual dissection of the lobe, this would potentially result in a twenty minutes time saving when a total (bilateral) thyroidectomy is done.
The safety of the Ligasure device is another important issue. We observed two patients with postoperative hoarseness in the Ligasure-arm. In both patients the hoarseness resolved spontaneously within seven weeks. The present trial was not designed or powered to demonstrate a difference or equivalence of safety, but in the aforementioned other trials there was no difference in frequency of recurrent nerve paralysis or postoperative bleeding [4, 5]. A recent meta-analysis showed that electrothermal bipolar vessel sealing systems are safe and efficient in other fields of surgery (even laparoscopic surgery) .
In conclusion, using LigaSure in thyroid surgery leads to a clinically relevant saving of operative time.
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