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The purpose of this national study was to examine the long-term results of transanal excision compared with major surgery of T1 rectal cancer.This prospective study from the Norwegian Rectal Cancer Project included all 291 patients with a T1M0 tumor within 15 cm from the anal verge treated by anterior resection, abdominoperineal resection, Hartmann's procedure, or transanal excision in the period from November 1993 to December 1999.Two hundred fifty-six patients were treated by major surgery and 35 patients by transanal excision. None of the patients had neoadjuvant therapy. Macroscopic tumor remnants (R2) occurred in 17 percent (6/35) of the transanal excisions, while major surgery obtained 100 percent R0 resections. Eleven percent of the patients treated with major surgery had glandular involvement. There were no significant differences according to tumor localization, size, or differentiation between Stage I and Stage III tumors. Patients treated with transanal excision were older than patients having major surgery (mean age, 77vs. 68 years,P< 0.001). After curative resection (R0, R1, Rx) the five-year rate of local recurrence was 12 percent (95 percent confidence interval, 0-24) in the transanal excision group compared with 6 percent (95 percent confidence interval, 2-10) after major surgery (P= 0.010). The overall five-year survival was 70 percent (95 percent confidence interval, 52-88) in the transanal excision group compared with 80 percent (95 percent confidence interval, 74-85) in the major surgery group (P= 0.04) and the five-year disease-free survival was 64 percent (95 percent confidence interval, 46-82) in the transanal excision group compared with 77 percent (95 percent confidence interval, 71-83) in the major surgery group (P= 0.01).The main problem of transanal excision for early rectal cancer in the present study was the inability to remove all the malignancy. Patients treated with transanal excision had significantly higher rates of local recurrence compared with patients who underwent major surgery. Patients who had transanal excision had inferior survival, but they were older than those who had major surgery.