The first clinical study to evaluate the safety and efficacy of a novel laparoscopic compression anastomosis clip (LapCAC) for laparoscopic gastroenterostomy.
The study was approved by the ethics committee of Shanghai Hospital of The Second Military Medical University. After signed informed consent, LapCAC was used for Roux-en-Y side-to-side intestinal anastomosis and gastroenterostomy in three patients. Evaluated parameters included anastomotic complications, return of normal bowel function and time to expulsion of LapCAC.
In March of 2007, one of three patients with gastric cancer underwent a total gastrectomy of which two underwent a distal subtotal gastrectomy. None of the patients had anastomotic complications such as leak, stricture or bowel obstruction after the operation. The intestinal exhaust and defecation was normal. The clip was expelled with stool within 12-18 days. Endoscopic examination after a 6-month follow-up showed a better healing at the compression anastomosis
LapCAC is safe and reliable for laparoscopic gastroenterostomy.
Program Number: P290