Phase II trial to evaluate laparoscopic surgery for Stage 0/I rectal carcinoma.
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.
Yamamoto
Seiichiro
S
Division of Colorectal Surgery, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. seyamamo@ncc.go.jp
Yoshimura
Kenichi
K
Konishi
Fumio
F
Watanabe
Masahiko
M
D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery*; D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D005240:Feasibility Studies; D006801:Humans; D007564:Japan; D010535:Laparoscopy; D008875:Middle Aged; D009367:Neoplasm Staging; D018579:Patient Selection; D012004:Rectal Neoplasms / Q000473:pathology / Q000601:surgery*; D012107:Research Design