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. REGISTRATION: 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. CONCLUSION: 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.
RCT Entities:
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. REGISTRATION: 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. CONCLUSION: 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.
Authors: Christoph M Seiler; Markus K Diener; Nuh Rahbari; Hartwig Bauer; Matthias Rothmund; Markus W Büchler Journal: Surgery Date: 2009-04-19 Impact factor: 3.982
Authors: F Hubertus Schmitz-Winnenthal; Simon Schimmack; Ben Lawrence; Uwe Maier; Miriam Heidmann; Markus W Buchler; Moritz von Frankenberg Journal: Langenbecks Arch Surg Date: 2011-08-02 Impact factor: 3.445
Authors: Thomas J Musholt; Thomas Clerici; Henning Dralle; Andreja Frilling; Peter E Goretzki; Michael M Hermann; Jochen Kussmann; Kerstin Lorenz; Christoph Nies; Jochen Schabram; Peter Schabram; Christian Scheuba; Dietmar Simon; Thomas Steinmüller; Arnold W Trupka; Robert A Wahl; Andreas Zielke; Andreas Bockisch; Wolfram Karges; Markus Luster; Kurt W Schmid Journal: Langenbecks Arch Surg Date: 2011-03-22 Impact factor: 3.445
Authors: C M Seiler; B E Fröhlich; J A Veit; E Gazyakan; M N Wente; C Wollermann; A Deckert; S Witte; N Victor; M W Buchler; H P Knaebel Journal: Trials Date: 2006-09-01 Impact factor: 2.279
Authors: S Coiro; F M Frattaroli; F De Lucia; E Manna; F Fabi; J M Frattaroli; G Pappalardo Journal: Langenbecks Arch Surg Date: 2015-01-13 Impact factor: 3.445
Authors: M Maneck; C Dotzenrath; H Dralle; C Fahlenbrach; R Paschke; T Steinmüller; E Tusch; E Jeschke; C Günster Journal: Chirurg Date: 2017-01 Impact factor: 0.955
Authors: Jane Candlish; M Dawn Teare; Munyaradzi Dimairo; Laura Flight; Laura Mandefield; Stephen J Walters Journal: BMC Med Res Methodol Date: 2018-10-11 Impact factor: 4.615