The COLOFOL trial: study design and comparison of the study population with the source cancer population

Figures & data

Table 1 Inclusion and exclusion criteria in the COLOFOL trial

Inclusion criteria	Exclusion criteria
R0 resection	Lynch syndrome or FAP
Age ≤75 years	Local excision (eg, TEM)
Written informed consent	Life expectancy <2 years
Clean colon	Inability or refusal to perform informed consent
Tumor stage II–III	Inability to comply with the control or intense follow-up program
Ability to perform informed consent	Participation in other clinical trials interfering with the COLOFOL study

Abbreviations: FAP, familial adenomatous polyposis; TEM, transanal endoscopic microsurgery.

Figure 1 Consort diagram of the COLOFOL trial.

Figure 2 Randomized and eligible patients per center.

Figure 3 Inclusion rate.

Table 2 Demography of randomized patients and eligible but nonrandomized patients in four major hospitals, n=1,221

Demographic parameters	Randomized patients (N=684)	Nonrandomized eligible patients (N=537)
Median age, years (range)	65 (15–76)	65 (15–75)
Colon cancer, n (%)	385 (56)	272 (51)
Rectal cancer, n (%)	299 (44)	264 (49)
Stage II, n (%)	383 (56)	265 (49)
Stage III, n (%)	301 (44)	272 (51)
Male, n (%)	408 (60)	323 (60)
Female, n (%)	276 (40)	214 (40)