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

Trials

Volumn 7, Issue , 2006, Pages

  Seiler, Christoph M ^a   Fröhlich, Boris E ^a   Veit, Johannes A ^a   Gazyakan, E ^a   Wente, Moritz N ^a   Wollermann, C ^a   Deckert, A ^a   Witte, S ^a   Victor, N ^a   Buchler, Markus W ^a   Knaebel, Hanns Peter ^a  

^a UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

POLYGLACTIN;

ARTICLE; BLOOD VESSEL OCCLUSION; CLINICAL PRACTICE; CLINICAL PROTOCOL; CLINICAL TRIAL; CLIP; DATA ANALYSIS; ELECTIVE SURGERY; GERMANY; HEALTH CARE SYSTEM; HEMOSTASIS; HUMAN; INTERMETHOD COMPARISON; MEDICAL DOCUMENTATION; MEDICAL EXPERT; MEDICAL SOCIETY; METHODOLOGY; OPERATION DURATION; OUTCOME ASSESSMENT; PATIENT SELECTION; SAFETY; SUBTOTAL THYROIDECTOMY; SURGEON; SURGICAL TECHNIQUE; SUTURING METHOD; SYSTEMATIC ERROR; THYROID DISEASE; THYROID SURGERY; THYROIDECTOMY;

EID: 33749343788     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-7-27     Document Type: Article

References (20)

1. M A, MJ C, DJ L: Repräsentative Studie zur Erfassung des Jodversorgungszustandes der Bevölkerung Deutschlands. Bundesministerium für Gesundheit (BMG) 1998.
2. 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.
3. Allan A, Cooper MJ, Leaper DJ: A new absorbable ligating clip for use in cholecystectomy. J R Coll Surg Edinb 1984, 29:53-54.
4. 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.
5. Voutilainen PE, Haapiainen RK, Haglund CH: Ultrasonically activated shears in thyroid surgery. Am J Surg 1998, 175:491-493.
6. Voutilainen PE, Haglund CH: Ultrasonically activated shears in thyroidectomies: a randomized trial. Ann Surg 2000, 231:322-328.
7. Bergamaschi R, Becouarn G, Ronceray J, Arnaud JP: Morbidity of thyroid surgery. Am J Surg 1998, 176:71-75.
8. Roher HD, Goretzki PE, Hellmann P, Witte J: [Complications in thyroid surgery. Incidence and therapy]. Chirurg 1999, 70:999-1010.
9. Thomusch O, Machens A, Sekulla C, Ukkat J, Lippert H, Gastinger I, Dralle H: Multivariate analysis of risk factors for postoperative complications in benign goiter surgery: prospective multicenter study in Germany. World J Surg 2000, 24:1335-1341.
10. Thomusch O, Machens A, Sekulla C, Ukkat J, Brauckhoff M, Dralle H: The impact of surgical technique on postoperative hypoparathyroidism in bilateral thyroid surgery: a multivariate analysis of 5846 consecutive patients. Surgery 2003, 133:180-185.
11. Koperna T: How long do we need teaching in the operating room? The true costs of achieving surgical routine. Langenbecks Arch Surg 2004, 389:204-208.
12. Friess H, Kleeff J, Buchler P, Hartwig W, Schmidt J, Radnic S, Auer S, Buchler MW: [Central patient management in surgery]. Chirurg 2002, 73:111-117.
13. Siperstein AE, Berber E, Morkoyun E: The use of the harmonic scalpel vs conventional knot tying for vessel ligation in thyroid surgery. Arch Surg 2002, 137:137-142.
14. Knaebel HP, Diener MK, Wente MN, Bauer H, Buchler MW, Rothmund M, Seiler CM: The Study Centre of the German Surgical Society-rationale and current status. Langenbecks Arch Surg 2005, 390:171-177.
15. Chan AW, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG: Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004, 291:2457-2465.
16. Boutron I, Tubach F, Giraudeau B, Ravaud P: Methodological differences in clinical trials evaluating nonpharmacological and pharmacological treatments of hip and knee osteoarthritis. JAMA 2003, 290:1062-1070.
17. Tresallet C, Chigot JP, Menegaux F: [How to prevent recurrent nerve palsy during thyroid surgery?]. Ann Chir 2006, 131:149-153.
18. Nies C, Celik I, Lorenz W, Koller M, Plaul U, Krack W, Sitter H, Rothmund M: [Outcome of minimally invasive surgery. Qualitative analysis and evaluation of the clinical relevance of study variables by the patient and physician]. Chirurg 2001, 72:19-28.
19. Victor N: On clinically relevant differences and shifted null hypotheses. Methods Inf Med 1987, 26:109-116.
20. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB: Clinical trial registration: a statement from the International Comittee of Medical Journal Editors. Lancet 2004, 364:911-912.