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. 2006 Sep 1:7:27.
doi: 10.1186/1745-6215-7-27.

Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery

C M Seiler  1 , 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
Affiliations

Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery

C M Seiler et al. Trials. .

Abstract

Background: Annually, more than 90000 surgical procedures of the thyroid gland are performed in Germany. Strategies aimed at reducing the duration of the surgical procedure are relevant to patients and the health care system especially in the context of reducing costs. However, new techniques for quick and safe hemostasis have to be tested in clinically relevance randomized controlled trials before a general recommendation can be given. The current standard for occlusion of blood vessels in thyroid surgery is ligatures. Vascular clips may be a safe alternative but have not been investigated in a large RCT.

Methods/design: CLIVIT (Clips versus Ligatures in Thyroid Surgery) is an investigator initiated, multicenter, patient-blinded, two-group parallel relevance randomized controlled trial designed by the Study Center of the German Surgical Society. Patients scheduled for elective resection of at least two third of the gland for benign thyroid disease are eligible for participation. After surgical exploration patients are randomized intraoperatively into either the conventional ligature group, or into the clip group. The primary objective is to test for a relevant reduction in operating time (at least 15 min) when using the clip technique. Since April 2004, 121 of the totally required 420 patients were randomized in five centers.

Discussion: As in all trials the different forms of bias have to be considered, and as in this case, a surgical trial, the role of surgical expertise plays a key role, and will be documented and analyzed separately. This is the first randomized controlled multicenter relevance trial to compare different vessel occlusion techniques in thyroid surgery with adequate power and other detailed information about the design as well as framework. If significant, the results might be generalized and may change the current surgical practice.

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References

    1. M A, MJ C, DJ L. Repräsentative Studie zur Erfassung des Jodversorgungszustandes der Bevölkerung Deutschlands. Bundesministerium für Gesundheit (BMG) 1998.
    1. Reiners C, Wegscheider K, Schicha H, Theissen P, Vaupel R, Wrbitzky R, Schumm-Draeger PM. Prevalence of thyroid disorders in the working population of Germany: ultrasonography screening in 96,278 unselected employees. Thyroid. 2004;14:926–932. doi: 10.1089/thy.2004.14.926. - DOI - PubMed
    1. Allan A, Cooper MJ, Leaper DJ. A new absorbable ligating clip for use in cholecystectomy. J R Coll Surg Edinb. 1984;29:53–54. - PubMed
    1. Clarke-Pearson DL, Creasman WT. A clinical evaluation of absorbable polydioxanone ligating clips in abdominal and pelvic operations. Surg Gynecol Obstet. 1985;161:250–252. - PubMed
    1. Voutilainen PE, Haapiainen RK, Haglund CH. Ultrasonically activated shears in thyroid surgery. Am J Surg. 1998;175:491–493. doi: 10.1016/S0002-9610(98)00073-7. - DOI - PubMed