[Operative standardization in randomized controlled surgical trials. Meeting of the INSECT trial]. / Operative Standardisierung bei randomisiert kontrollierten Studien in der Chirurgie. Studientreffen der INSECT-Studie.
Chirurg
; 77(3): 267-72, 2006 Mar.
Article
em De
| MEDLINE
| ID: mdl-16496099
ABSTRACT
BACKGROUND:
INSECT is an internationally registered, three-armed, multicentre, intraoperatively randomised model trial of the Study Centre of the German Surgical Society. The interventions being compared are running suture technique with slowly absorbable monofilament suture material (PDS vs MonoPlus) and interrupted technique with a braided, rapidly absorbable suture material (Vicryl). The primary endpoint is the rate of incisional hernias 1 year postoperatively. MATERIAL ANDMETHODS:
A total of 25 surgeons from 24 different institutions at all levels of care evaluated the theoretical and practical sessions of the surgical investigator meeting using 25 criteria, including course organisation, content, and speaker evaluation, and a categorical grading system from 1 (very good) to 6 (insufficient).RESULTS:
Distribution of the 625 grades was very good (1) n=367, good (2) n=207, satisfactory (3) n=39, adequate (4) n=2, and "No statement" n=10. The average score for the investigator meeting was 1.5.CONCLUSION:
The participants felt they were successfully prepared theoretically and practically for trial interventions and conduct by attending the meeting. Clear explanation of the measures for treatment equivalence before and during trials is mandatory in randomised controlled surgical trials.
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Base de dados:
MEDLINE
Assunto principal:
Poliglactina 910
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Complicações Pós-Operatórias
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Pesquisadores
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Deiscência da Ferida Operatória
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Suturas
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Protocolos Clínicos
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Técnicas de Sutura
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Desenvolvimento de Pessoal
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Polidioxanona
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Parede Abdominal
Idioma:
De
Ano de publicação:
2006
Tipo de documento:
Article