[Multicentric randomised controlled trials in Germany: overview and interim analysis 1 year after inclusion of in the rubric "Clinical Trials"]. / Rekrutierende multizentrische chirurgische Studien in Deutschland : Zwischenbilanz ein Jahr nach Einführung der Rubrik.

ABSTRACT

BACKGROUND: For 1 year now, German surgical multicentric randomised controlled trials (MRCT) in Germany may be included under the heading "Clinical Trials" in our monthly updated trial list. MATERIAL AND METHODS: Quantitative and qualitative analysis of MRCT presented in the trial list was performed to give an overview and interim statement 1 year after implementation of the journal heading "Clinical Trials". RESULTS: In 1 year, the study list increased from four to eleven MRCT and the numbers of randomized patients from 396 to 1511. The MRCT show distinct differences regarding funding sources and reimbursement for participating centres per patient included. The study protocols of four of 11 MRCT were published in scientific journals. CONCLUSION: The new regular heading gives important details about ongoing surgical trials in Germany. The steady growth of trials and recruited patients demonstrates the practicability of randomized controlled trials in surgery.