Research
Print page Print page
Switch language
Bispebjerg Hospital - a part of Copenhagen University Hospital
Published

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

Research output: Contribution to journalJournal articleResearchpeer-review

DOI

  1. The Danish Myelodysplastic Syndromes Database: Patient Characteristics and Validity of Data Records

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. The association between rhabdomyolysis, acute kidney injury, renal replacement therapy, and mortality

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Fetal Programming of Semen Quality (FEPOS) Cohort - A DNBC Male-Offspring Cohort

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Tomografía computarizada para el diagnóstico de la apendicitis aguda en adultos

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Computed tomography for diagnosis of acute appendicitis in adults

    Research output: Contribution to journalReviewResearchpeer-review

  3. Local recurrence rate in a national Danish patient cohort after curative treatment for rectal cancer

    Research output: Contribution to journalJournal articleResearchpeer-review

View graph of relations

INTRODUCTION: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL trial, comparing demographic characteristics between randomized patients and eligible patients not included in the study.

MATERIALS AND METHODS: COLOFOL was designed as a pragmatic trial with wide inclusion criteria and few exclusion criteria, in order to obtain a sample reflecting the general patient population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24 participating centers, we scrutinized hospital inpatient data to identify all colorectal cancer patients who underwent surgery, in order to ascertain all eligible patients who were not included in the study and to compare them with enrolled patients.

RESULTS: Of a total of 4,445 eligible patients, 2,509 patients were randomized (56.4% inclusion rate). A total of 1,221 eligible patients were identified in the scrutinized hospitals, of which 684 (56%) were randomized. No difference in age or sex distribution was observed between randomized and nonrandomized eligible patients. However, a difference was noted in tumor location and stage distribution, with 5.6% more patients in the randomized group having colon cancer and 6.7% more patients having stage II disease.

CONCLUSION: Patients in the two study arms were not only demographically similar, but also similar to nonincluded eligible patients, apart from stage and localization. The analyses will be stratified by these variables. Taken together, we conclude that our trial results will be robust and possible to extrapolate to the target population.

Original languageEnglish
JournalClinical Epidemiology
Volume8
Pages (from-to)15-21
Number of pages7
ISSN1179-1349
DOIs
Publication statusPublished - 2016

ID: 46339160