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Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma

2008; Oxford University Press; Volume: 38; Issue: 7 Linguagem: Inglês

10.1093/jjco/hyn054

1465-3621

S Yamamoto, Kenichi Yoshimura, Fumio Konishi, Masahiko Watanabe,

Colorectal and Anal Carcinomas

Recently reported randomized controlled trials demonstrated that laparoscopic surgery (LS) was comparable or superior to open surgery with regard to the long-term outcome for colon and rectosigmoidal carcinoma; however, controversy persists with regard to the appropriateness of LS for patients with rectal carcinoma. To examine the technical and oncological feasibility of LS for rectal carcinoma, a phase II trial was started in patients with a preoperative diagnosis of Stage 0/I rectal carcinoma, under the direction of the Japan Society of Laparoscopic Colorectal Surgery. Surgeons in 39 specialized institutions will recruit 350 patients. The primary end-point in the first stage is the anastomotic leakage rate by double-stapling technique and that in the second stage is overall survival. Secondary end-points are relapse-free survival, short-term clinical outcome, adverse events, the rate of histologically curative operation, the proportion of completion of LS and the conversion rate.