Studie zur Vorbeugung von
Darmpolypen mit Grüntee-Extrakt

Participants

The study will be performed nationwide in Germany. Patients will be recruited from gastroenterological centers that are performing a high number of screening and interventional colonoscopies. Participants undergoing screening colonoscopy who are diagnosed with colorectal adenomas will be randomized within 6 months after polypectomy if they give informed consent. Participants who are willing to participate in the trial will undergo a short screening interview and then enter the run-in phase of 4 weeks, in which all participants of the trial will receive verum. This run in-phase is designed to obtain information about potential and unforeseen side effects of green tea extract intake that might affect the well-being of the participants or the blinding of the trial. Randomization will follow after a successful run-in period. Participants who are not compliant to the study protocol or do not tolerate the green tea extract supplementation will not be randomized.

As judged from similar trials, we expect a 15% dropout rate after run-in. Thus, 2941 participants will be included in the run-in phase in order to achieve a total number of 2534 randomized participants (Figure (Figure11).

In Germany, about 500,000 individuals undergo screening colonoscopies each year. A large colonoscopy center typically performs more than 3000 colonoscopies per year. In 10-15% of these screenings, adenomas are detected and removed. We expect that about half of these cases will be eligible for study inclusion. About 30 colonoscopy centers will take part in this study, in order to allowing us to recruit the planned number of participants in the intended 3-year period.

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