Short-term Outcomes of Laparoscopic Intersphincteric Resection From Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/i Rectal Carcinoma: Japan Society of Laparoscopic Colorectal Surgery Lap Rc (nct00635466)

Shoichi Fujii, MD PhD, Seiichiro Yamamoto, MD PhD, Masaaki Ito, MD PhD, Shigeki Yamaguchi, MD PhD, Kazuhiro Sakamoto, MD PhD, Yusuke Kinugasa, MD PhD, Yukihito Kokuba, MD PhD, Junji Okuda, MD PhD, Kenichi Yoshimura Kenichi Yoshimura, MD PhD, Masahiko Watanabe, MD PhD. Japan Society of Laparoscopic Colorectal Surgery


(Introduction) To examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma, we conducted a phase II trial to evaluate laparoscopic surgery for stage 0/I rectal carcinoma in patients with a preoperative diagnosis of stage 0/I rectal carcinoma. Intersphincteric resection (ISR) is a promising method of sphincter-preserving surgery for very low rectal cancer. Laparoscopic ISR (LISR) is still not an established technique, and its safety and feasibility were unclear. The aim of this study was to clarify the safety and feasibility of LISR in a prospective multicenter study of laparoscopic surgery for clinical Stage 0/I rectal cancer in Japan (Lap RC). (Method) Only accredited surgeons specialized in laparoscopic surgery for the colon and rectum from 43 institutions in Japan participated in the study. Eligibility criteria included histologically proven rectal carcinoma; clinical stage 0/I; tumor size ?8 cm; patient age 20-75 years; no bowel obstruction; no prior chemotherapy or radiotherapy; written informed consent. The planned sample size was 490. Between February 2008 and September 2010, 495 patients with rectal cancer underwent laparoscopic surgery in 43 hospitals throughout Japan. All data of patient’s background, operative and postoperative outcomes were recorded prospectively. (Results) A total of 495 patients were registered, and of those, 78 patients (15.8%) underwent LISR. Mean age was 58.9 years (31-77), male was 52 patients (66.7%) and female was 26 patients (33.3%). Diverting stoma was performed in 69 patients (88.5%). Conversion to open surgery occurred in 4 patients (5.1%). Reason for conversion in 2 patients (2.6%) was uncontrollable bleeding, and it for other 2 patients (2.6%) was necessity of pelvic side wall lymph node dissection. There was no mortality. Median operative time was 345 minutes (198-565), amount of blood loss was 100 ml (0-1760), and 3 patients (3.9%) were transfused intraoperatively. Median number of dissected lymph node was 14 (3-33), and all (proximal, distal and vertical) pathological cut margins were negative. Postoperative surgical complication of Grade2 or more was detected in 12 patients (15.4%), including anastomotic leakage in 5 patients (6.4%), bowel obstruction in 5 patients (6.4%) and surgical site infection in 2 patients (2.6%). Abdominal drainage and diversion of intestine were necessary in 2 patients (2.6%) due to anastomotic leakage. Median length of postoperative hospital stay was 13 days (7-167).
(Conclusion) LISR was feasible and safe for clinical Stage 0/I rectal cancer with favorable short-term outcome. The safety of this procedure requires confirmation through prospective accumulation of more cases.

Session Number: SS20 – Colorectal
Program Number: S108

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