Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy

Introduction: Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field of investigational surgery which uses the endoscope as the primary operative tool. The insertion sites for the endoscope include natural orifices such as the mouth, anus, vagina, or urethra. Multiple animal studies utilizing similar techniques are ongoing at several institutions, including Baystate Medical Center. These multidisciplinary teams consist of surgeons and gastroenterologists who are collaborating to develop safe and effective surgical techniques via the natural orifice route in order to avoid surgical incisions.

The NOTES team at Baystate began animal studies in May, 2006. Multiple procedures, including but not limited to uterine horn resection (simulating appendectomy), cholecystectomy, nephrectomy, splenectomy, distal pancreatectomy, small bowel resection, mediastinal exploration, and sleeve gastrectomy have been completed successfully by the team. This work has led to a separate, IRB-approved protocol to perform NOTES pancreatic pseudocystgastrostomy in human patients. To date, 2 patients have successfully undergone entirely transluminal, endoscopic cystgastrostomy with a third case upcoming. The focus of much of our research (as well as that of many other investigators), is to develop a secure closure method for the stomach. Unfortunately, key scientific questions remain regarding this technique and thus have limited human trials to date. Given this, we have begun to explore other access techniques.

Gynecologists have long considered transvaginal access to the peritoneum as a safe route of entry into the abdomen. Transvaginal hysterectomy and transvaginal tubal ligation have indeed become a regular part of the gynecologic armamentarium. NOTES surgeons have learned from this access approach and have begun to employ it as a safe route into the abdomen. In fact, investigators in New York1,2; San Diego3; Strasbourg, France4; Mallorca, Spain5; Hamburg, Germany6, Milan, Italy7; and Rio de Janeiro8,9 and São Paulo10, Brazil have all announced transvaginal NOTES procedures involving the gallbladder. All of these approaches, to date, have utilized one or more laparoscopic trocars for safety reasons.

Primary Objective: The primary objective of this pilot study is to demonstrate that the Natural Orifice Translumenal Endoscopic Surgery (NOTES) transvaginal cholecystectomy technique is as safe and effective as standard laparoscopic surgical technique for the resection of gallbladder.

Hypothesis: Patients who undergo Natural Orifice Translumenal Endoscopic Surgery for treatment of their gallbladder disease will experience effective treatment with less discomfort and with quicker recovery than standard surgical techniques.