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An interim analysis of recruitment to the COLOFOL trial
Author(s) -
WilleJørgensen P.,
Laurberg S.,
Påhlman L.,
Carriquiry L.,
Lundqvist N.,
Smedh K.,
Svanfeldt M.,
Bengtson J.
Publication year - 2009
Publication title -
colorectal disease
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.029
H-Index - 89
eISSN - 1463-1318
pISSN - 1462-8910
DOI - 10.1111/j.1463-1318.2008.01668.x
Subject(s) - medicine , interim analysis , inclusion and exclusion criteria , randomized controlled trial , interim , colorectal cancer , inclusion (mineral) , population , multicenter trial , clinical trial , stage (stratigraphy) , surgery , cancer , general surgery , multicenter study , alternative medicine , pathology , gender studies , paleontology , environmental health , archaeology , sociology , biology , history
Objective To analyse the ongoing process of recruiting patients into a multicenter randomized trial on follow‐up after curative surgery for colorectal cancer. The trial is registered in Clinical Trials Registration. Method Prospective registration of all operated patients as well as inclusions (curative resection, stage II or III disease, ≤ 75 years, clean colonand exclusions of the individual patients in eight participating departments. Results Between January 2006 and September 2007, 1309 patients have been operated upon. Of these 502 (38.3 %) met the inclusion criteria, 148 (29.5%) had exclusion criteria. Of the final eligible patients 241 (68.1 %) were randomized. No specific barriers to inclusion were identified. Conclusion Of an overall population of patients operated for colorectal cancer about one in five were randomized. Bearing the rigorous inclusion and exclusion criteria in mind, this is considered satisfactory, and the investigated population may be representative of patients meeting the inclusion criteria.