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Ann Surg. 2013 Aug;258(2):283-8. doi: 10.1097/SLA.0b013e318283669c.

Laparoscopic surgery for stage 0/I rectal carcinoma: short-term outcomes of a single-arm phase II trial.

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Division of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan.



To examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma, we conducted a single-arm phase II trial to evaluate laparoscopic surgery for stage 0/I rectal carcinoma, and short-term surgical outcomes were evaluated.


Accredited surgeons from 43 institutions in Japan participated in the study. Eligibility criteria included histologically proven rectal carcinoma; clinical stage 0/I; tumor size 8 cm or smaller; patient age 20 to 75 years; no bowel obstruction; and written informed consent. Patients were registered preoperatively. The planned sample size was 490. Surgical outcomes were evaluated.


A total of 495 patients were registered between February 2008 and August 2010. Five patients were ineligible after registration. Conversion to open surgery was needed for 8 (1.6%) patients. Sphincter-preserving procedures were performed in 477 (97%) patients. Median operative time was 270 minutes, and median blood loss was 28 mL. Postoperative median intervals until liquid and solid intake were 1 and 3 days, respectively, and the median postoperative hospital stay was 12 days. The positive resection margin rate was 0.4% (2/490), and 68.6% (336/490) of the patients were graded stage 0/I. There were no perioperative mortalities. Twenty-four intraoperative and 160 postoperative complications occurred, and the morbidity rate was 23.9% (117/490). The anastomotic leakage rate in patients who underwent anterior resection was 8.3% (33/400), and that in patients who underwent intersphincteric resection was 9.1% (7/77). Nineteen (3.9%) patients underwent reoperation.


Technically, laparoscopic surgery can be used for safe and radical resection of clinical stage 0/I rectal carcinoma. ( No. NCT00635466.).

[Indexed for MEDLINE]

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