Prospective Evaluation of Quality of Life in Patient With Rectal Cancer
Eligibility criteria: Italian people with adenocarcinoma of rectum. Exclusion criteria
consisted of age younger than 18 years, history of psychiatric illness, and preoperative
radiotherapy.
Outcome measures: patient was carried out using a EORTC QLQ-C30/C38 questionnaire.To
determine how surgery affects QoL, we divided patients into two groups: first rectal cancer
submitted to rectal anterior resection(RAR) and latter rectal cancer submitted to rectal
anterior resection with stomia(RARS). Differences in QoL between the two groups were
analyzed during three time: first preoperative, second postoperative and latter six month
later of after the stoma reconversion in RARS patients
Observational
Observational Model: Cohort, Time Perspective: Prospective
Questionnaire number 1, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
Two cohort in preoperative time: first EORTC QLQ-C30/C38 questionnaire in rectal cancer submitted to RAR and latter in rectal cancer submitted to RARS.
three month: first admission in hospital preoperative time
No
alberto vannelli, MD
Study Director
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Italy: Ethics Committee
INT-D176768
NCT01181557
September 2008
December 2009
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