International Quality Assurance in Colorectal Carcinoma

The international multicenter study "Quality Assurance in Colorectal Carcinoma" is conducted as a joint project between the Department of General, Visceral and Vascular Surgery and the Institute for Quality Assurance in Operative Medicine at the University of Magdeburg in Germany. The study was started in 2000 and has registered up to now over 60,000 patients. Since the end of 2007 hospitals from Poland take part in the project, and further European enlargement has been initiated.

The collected data represents the current state of treatment of patients in routine clinical practice, and it covers the entire spectrum of hospital types. A total of over 370 institutions providing treatment at all levels take part in the study. The individual data is recorded on a standardised questionnaire at each participating hospital. This questionnaire comprises 71 questions to record the important aspects of perioperative management of the patient: demographic characteristics, pre and postoperative tumour status, tumour location, details of the operation and perioperative treatment, pathological findings, hospital mortality, the patient's status upon discharge from hospital, and further treatment planned. Since the beginning of 2009 the paper questionnaires are not used any more; the data is entirely entered via bilingual internet platforms. Plausibility checks are conducted live during data entry as well as quality control by the study monitor after completion of the online questionnaire.

The study is conducted in accordance with the Declaration of Helsinki.
Participation in the study is voluntary, and data is recorded anonymously.
All the patients give written consent to the acquisition and anonymised evaluation of their data. The double anonymity of patients and hospitals is warranted.

Long-term outcome data are obtained with the help of a second questionnaire completed online either by the patient's general practitioner or by the hospital at which the operation took place; this includes last contact with the patient, quality of life status or cause of death (tumour-related, tumour-independent), any local recurrence, distal metastasis, and as appropriate the time of recurrence and the method of detection (biopsy, endoscopy, imaging).

Since 2009 the project is under the direction of Dr. Pawel Mroczkowski, who can be contacted for further information by e-mail:
, phone:+49 391 6715504 or fax +49 391 67 290212.