Abstract:Objective: To evaluate the safety and utility of domestic disposable double stapling device in anus-preserving operation for mid/low rectal cancer. Methods: The clinical data of 63 patients with mid/low rectal cancer undergoing anus-preserving operation from May 2005 to December 2010 by using domestic disposable double stapling device were retrospectively analyzed. Results: Of the patients, 40 were male and 23 were female. The average age was 64.5±1.7 (34–85) years, the median distance between the tumor lower edge and anal verge was 6.0 (4.0–10.0) cm and the median tumor size was 4.0 (1.3–11.0) cm. The TNM stages were stage I (9 cases, 14.3%), stage II (17 cases, 27.0%), stage III (28 cases, 44.4%) and stage IV (9 cases, 14.3%). All the 63 patients underwent a single anastomosis without reinforcement. All staple lines were intact and complete without breakdown. Complications occurred in 6 cases after surgery (2 cases of anastomotic leakage, 1 case each of anastomotic stricture, wound infection, pneumonitis and gastric retention, respectively) and there was no perioperative death. Fifty-two patients (82.5%) were followed up with a median period of 32 (7–67) months, during which time, 13 cases died from distant metastases. The 3- and 5-year survival rate was 82.7% and 62.3%, respectively. Conclusion: Domestic disposable double stapling device is safe and feasible for sphincter-preserving operation of mid/low rectal cancer.