Vascular clips versus ligatures in thyroid surgery--results of a multicenter randomized controlled trial (CLIVIT Trial).
BACKGROUND
New techniques using vascular clips or ultrasonically activated shears have been suggested to shorten operation time without compromising safety. The objective of the CLIVIT Trial was to compare ligatures with vascular clips for hemostasis in elective benign thyroid surgery.


METHODS
This multicenter, randomized, controlled, parallel group superiority trial was conducted in 13 German surgical centers. Patients scheduled for at least subtotal resection bilaterally were intraoperatively randomized. The primary endpoint was resection time. Secondary endpoints were the amount of postoperative bleeding, reoperation due to bleeding, wound infection, temporary (reversal within 12 months) and permanent (over 1 year) recurrent laryngeal nerve (RLN) paralysis, length of hospital stay, and safety.


BACKGROUND
ISRCTN 96901396.


RESULTS
Two hundred fifty patients were treated with ligatures and 241 with vascular clips. No differences in patients' baseline and surgical characteristics were observed. No difference was detected for mean resection time (clip 63.5 min ± 29.6, ligature 66.1 min ± 29.3, P = 0.258). Postoperative bleeding (mean 86 ml ± 93), reoperation due to bleeding (clips 4, ligature 2), wound infections (clips 4, ligature 4), postoperative hospital stay (mean 3.0 ± 1.9), and safety data also did not vary significantly. The rates of temporary and permanent RLN paralysis were 6.9 % (34/491) and 2.9 % (14/491), respectively. Not using a surgical drain (123 patients) was not associated with a higher rate of complications.


CONCLUSIONS
Vascular clips did not reduce the resection time. However, a 2.9 % rate of permanent RLN paralysis is of concern. Drains in elective surgery may be of no benefit.
Study Center of the German Surgical Society and Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.
Markus K
MK
Diener
Christoph M
CM
Seiler
Moritz
M
von Frankenberg
Kathleen
K
Rendel
Silke
S
Schüle
Katja
K
Maschuw
Stefan
S
Riedl
Jens C
JC
Rückert
Christian
C
Eckmann
Uwe
U
Scharlau
Alexis
A
Ulrich
Thomas
T
Bruckner
Hanns-Peter
HP
Knaebel
Matthias
M
Rothmund
Markus W
MW
Büchler
D000704:Analysis of Variance; D016063:Blood Loss, Surgical / Q000706:statistics & numerical data; D005260:Female; D005858:Germany / Q000453:epidemiology; D006042:Goiter / Q000601:surgery*; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data; D008026:Ligation; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D061226:Recurrent Laryngeal Nerve Injuries / Q000453:epidemiology; D013525:Surgical Instruments; D013965:Thyroidectomy / Q000379:methods*; D016896:Treatment Outcome