Prospective trial evaluating new circular and linear stapler devices for gastrointestinal anastomosis: preliminary data.

Several commercial models of stapler devices are available. This study evaluated the ease of use, effectiveness and safety of new commercial stapling devices for gastrointestinal anastomosis. A total of 11 patients (5 men) requiring surgical therapy for benign or malignant disease of the digestive tract were recruited between July and October 2006. Eleven patients were treated with KYGW circular stapler or KYFB linear stapler (Changzhou Kangdi Medical Stapler). In these patients, 14 staplers were used and 21 stapled sutures (16 linear, 5 circular) were performed. Number of anastomoses successfully completed, postoperative anastomotic fistula or dehiscence, days to take fluid and normal diet, length of hospital stay and anastomotic stenosis were recorded. A 10-point questionnaire enquiring about the instrument and anastomotic features was administered to surgeons immediately after the operation in the study group and in 10 control patients treated with standard CDH circular and SDH linear staples (Ethicon Endo-Surgery). Mean scores on the questionnaire for the experimental and control groups were good (>7.5) and did not significantly differ for handling, closing ease, bleeding, and overall satisfaction. No case of intra-abdominal sepsis, leakage or intestinal obstruction was recorded in the study group. In the 5 patients with colorectal anastomosis, the anastomotic lumen at 15 days was wide open and at 3 months there were no strictures. These new instruments are valuable for performing gastrointestinal anastomosis and are in conformity with clinical requirements; their use is simple and seems to be safe.