BACKGROUND: This study aimed to compare the results and the oncologic outcomes of transanal endoscopic microsurgery (TEM) with neoadjuvant radiochemotherapy and laparoscopic resection (LR), also with neoadjuvant radiochemotherapy, in the treatment of T(2)-N(0) low rectal cancer. METHODS: The study enrolled 40 patients with T2-N(0) rectal cancer, randomizing 20 to TEM (arm A) and 20 to LR (arm B). RESULTS: After neoadjuvant radiochemotherapy, tumor downstaging was observed for 13 patients (65%) in arm A (7 pT0 and 6 pT1) and in 11 patients (55%) in arm B (7 pT0 and 4 pT1). More than a 50% reduction of the tumor diameter was observed in four arm A cases and in six arm B cases. At a median follow-up period of 56 months (range, 44-67 months) in both arms, one local failure (5%) occurred after 6 months in arm A and one (5%) after 48 months in arm B. Distant metastases occurred in one arm A patient (5%) after 26 months of follow-up evaluation and in one arm B patient (5%) at 31 months. The probability of local or distant failure was 10% for TEM and 12% for laparoscopic resection, whereas the probability of survival was 95% for TEM and 83% for laparoscopic resection. CONCLUSIONS: The findings show comparative results between the two study arms in terms of probability of failure and survival.
RCT Entities:
BACKGROUND: This study aimed to compare the results and the oncologic outcomes of transanal endoscopic microsurgery (TEM) with neoadjuvant radiochemotherapy and laparoscopic resection (LR), also with neoadjuvant radiochemotherapy, in the treatment of T(2)-N(0) low rectal cancer. METHODS: The study enrolled 40 patients with T2-N(0) rectal cancer, randomizing 20 to TEM (arm A) and 20 to LR (arm B). RESULTS: After neoadjuvant radiochemotherapy, tumor downstaging was observed for 13 patients (65%) in arm A (7 pT0 and 6 pT1) and in 11 patients (55%) in arm B (7 pT0 and 4 pT1). More than a 50% reduction of the tumor diameter was observed in four arm A cases and in six arm B cases. At a median follow-up period of 56 months (range, 44-67 months) in both arms, one local failure (5%) occurred after 6 months in arm A and one (5%) after 48 months in arm B. Distant metastases occurred in one arm A patient (5%) after 26 months of follow-up evaluation and in one arm B patient (5%) at 31 months. The probability of local or distant failure was 10% for TEM and 12% for laparoscopic resection, whereas the probability of survival was 95% for TEM and 83% for laparoscopic resection. CONCLUSIONS: The findings show comparative results between the two study arms in terms of probability of failure and survival.
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