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Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Short-term outcomes of laparoscopic intersphincteric resection from a phase II trial to evaluate laparoscopic surgery for stage 0/I rectal cancer: Japan Society of Laparoscopic Colorectal Surgery Lap RC.
Surgical Endoscopy 2012 November
BACKGROUND: Laparoscopic intersphincteric resection (Lap ISR) is not yet an established technique and its safety and feasibility are unclear. Our aim was to clarify the safety and feasibility of Lap ISR for clinical stage 0/I rectal cancer (Lap RC) in a prospective multicenter study of laparoscopic surgery in Japan.
METHODS: To examine the technical and oncological feasibility of laparoscopic surgery for rectal cancer, we conducted a confirmatory phase II trial to evaluate laparoscopic surgery for preoperative clinical stage 0/I rectal cancer. Eligibility criteria included histologically proven carcinoma, size ≤ 8 cm, age 20-75 years, no bowel obstruction, and no prior chemotherapy or radiotherapy. Between February 2008 and September 2010, 495 patients with rectal cancer underwent laparoscopic surgery at 43 institutions. Patients' background characteristics and operative and postoperative outcomes were recorded prospectively.
RESULTS: Seventy-seven patients (15.6 %) underwent Lap ISR. A diverting stoma was created in 69 patients (89.6 %). Conversion to open surgery occurred in 4 patients (5.2 %): 2 patients were converted because of uncontrollable bleeding, and the other 2 patients because of the need for pelvic side wall lymphadenectomy. There was no mortality. Median operative time was 345 min (range = 198-565), median amount of blood loss was 100 ml (range = 0-1760), and three patients (3.9 %) were transfused intraoperatively. The median number of dissected lymph nodes was 14 (range = 3-33), and all (proximal, distal, and vertical) pathological cut margins were negative. Postoperative complications of grade 2 or more were detected in 17 patients (22.1 %), including anastomotic leakage in 5 (6.4 %), bowel obstruction in 5 (6.5 %), and surgical site infection in 2 (2.6 %). Abdominal drainage and diverting stoma were necessary in two patients (2.6 %) due to anastomotic leakage. Median length of postoperative hospital stay was 13 days (range = 7-167).
CONCLUSION: Lap ISR was feasible and safe for clinical stage 0/I rectal cancer with favorable short-term outcome.
METHODS: To examine the technical and oncological feasibility of laparoscopic surgery for rectal cancer, we conducted a confirmatory phase II trial to evaluate laparoscopic surgery for preoperative clinical stage 0/I rectal cancer. Eligibility criteria included histologically proven carcinoma, size ≤ 8 cm, age 20-75 years, no bowel obstruction, and no prior chemotherapy or radiotherapy. Between February 2008 and September 2010, 495 patients with rectal cancer underwent laparoscopic surgery at 43 institutions. Patients' background characteristics and operative and postoperative outcomes were recorded prospectively.
RESULTS: Seventy-seven patients (15.6 %) underwent Lap ISR. A diverting stoma was created in 69 patients (89.6 %). Conversion to open surgery occurred in 4 patients (5.2 %): 2 patients were converted because of uncontrollable bleeding, and the other 2 patients because of the need for pelvic side wall lymphadenectomy. There was no mortality. Median operative time was 345 min (range = 198-565), median amount of blood loss was 100 ml (range = 0-1760), and three patients (3.9 %) were transfused intraoperatively. The median number of dissected lymph nodes was 14 (range = 3-33), and all (proximal, distal, and vertical) pathological cut margins were negative. Postoperative complications of grade 2 or more were detected in 17 patients (22.1 %), including anastomotic leakage in 5 (6.4 %), bowel obstruction in 5 (6.5 %), and surgical site infection in 2 (2.6 %). Abdominal drainage and diverting stoma were necessary in two patients (2.6 %) due to anastomotic leakage. Median length of postoperative hospital stay was 13 days (range = 7-167).
CONCLUSION: Lap ISR was feasible and safe for clinical stage 0/I rectal cancer with favorable short-term outcome.
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