Objectives: Laparoscopic colorectal surgery is widespread in the wourld, but the rate of rectal cancer, has increased more slowly than that of colon cancer. There are several technical problems in the performance of laparoscopic surgery for rectal cancer. It is technically difficult to precisely transect and anastomose the rectum in patients with a narrow intrapelvic space, with tumors located low in the rectum, or with bulky tumor, all of which have led to a high incidence of anastomotic leakage. We are currently conducting a phase II trial for stage II/III rectal cancer from April 2007. We demonstrate the preliminary results of clinical outcomes of this trial.
Study design: The primary endpoint is the rate of anastomotic leakage. Secondary endpoints are the rate of intraoperative or postoperative complications, the rate of conversion to open surgery, the rate of histologically curative resection, relapse-free survival, overall survival, and short-term clinical outcome. Inclusion criteria are histologically proven adenocarcinoma, tumor located in the rectum, TNM stage II/III, tumor size less than 8 cm, no bowel obstruction, etc. Eighty patients will be recruited for this study.
Results: Eighty-two patients have been registered in this trail. In clinicopathologic data, there were 40 patients (48%) with stage II disease, and 31 (38%) with stage III. In 82 patients with rectal cancer, high anterior resection (HAR) was perfomed in 30, low anterior resection (LAR) in 36, ultra-LAR in 8, and ultra-LAR with inner sphincter resection (ISR) in 8. Mean blood loss was 85 ml, and surgical time was 263 min. The complication rate was 12%, and the rate of anastomotic leakage was 1%. Disease-free survival rate was 96.7% for stage I, 88.8% for stage II, and 79.6% for stage III disease (median follow-up time 21 months).
Conclusions: Our prospective study demonstrates that laparoscopic surgery for stage II/III rectal cancer is feasible and technically safe. Use of surgical techniques based on the various tips and tricks I showed today are effective to help avoid complications. Further elucidation of oncological outcomes of laparoscopic surgery for stage II/III rectal cancer will be required.
Program Number: P119