Background and Objectives: 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.
Methods: 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.
Results: 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.
Conclusions: Technically, laparoscopic surgery can be used for safe and radical resection of clinical stage 0/I rectal carcinoma. (ClinicalTrials.gov No. NCT00635466.)
A single-arm phase II trial to evaluate laparoscopic surgery for stage 0/I rectal carcinoma was conducted. Accredited surgeons from 43 institutions in Japan participated, and a total of 495 patients were registered. Technically, laparoscopic surgery can be used for the safe and radical resection of clinical stage 0/I rectal carcinoma.
*Division of Colorectal Surgery, National Cancer Center Hospital, Tokyo
†Colorectal Surgery Division, National Cancer Center Hospital East, Chiba
‡Department of General and Gastroenterological Surgery, Osaka Medical College, Osaka
§Department of Surgery, Gastroenterological Center, Yokohama City University, Yokohama
¶Department of Gastroenterological Surgery, Saitama Medical University International Medical Center, Saitama
‖Translational Research Center, Kyoto University Hospital, Kyoto
**Department of Surgical Oncology, Tokyo Medical and Dental University, Tokyo
††Department of Surgery, Kitasato University Hospital, Kanagawa, Japan.
Reprints: Seiichiro Yamamoto, MD, PhD, Division of Colorectal Surgery, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. E-mail: email@example.com.
Disclosure: This study was supported by the Japanese Society for Cancer of the Colon and Rectum. The authors declare no conflicts of interest.
Trial registration: ClinicalTrials.gov: NCT00635466.