Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy
Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy
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.
 Multidisciplinary teams of surgeons and gastroenterologists collaborate to develop safe and
 effective surgical techniques via the natural orifice route in order to avoid surgical
 incisions. Early studies have focused on transvaginal surgery as the access route to the
 abdomen as it sidesteps troubling questions about infection and closure of the organ. This
 study is a pilot study to test the feasibility to NOTES transvaginal cholecystectomy using
 conventional surgical and endoscopic tools.
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.

 Introduction: The NOTES team (surgeon and gastroenterologist) at Baystate has extensive
 experience with animal work in developing novel techniques with commercially available
 products. Despite performing cholecystectomies in porcine models both through a transgastric
 and transvaginal approach, we have yet to perform a human case. The surgeons on the team have
 performed well over a thousand laparoscopic cholecystectomies; the gastroenterologist is a
 recognized advanced therapeutic endoscopist; and the gynecologist is an expert in
 transvaginal surgery. We believe that our combination of human experience and animal research
 will lead to safe attempts to perform the procedure described herein.

 Methods: There will be a total of 3 patients undergoing this experimental surgical procedure
 once meeting all entry criteria and subsequent to obtaining informed consent These patients
 will be recruited from the Baystate ambulatory surgery clinics.. Preoperative laboratory
 testing, such as blood work (liver function tests, amylase and lipase, a white blood cell
 count, and a pregnancy test), as well as ultrasound of the liver to document gallbladder
 disease will be performed as is the standard for patients undergoing surgical removal of the
 gallbladder. In this procedure, after the induction of general anesthesia and creation of a
 culdotomy, a sterile endoscope would be inserted into the vagina and then into the abdomen.
 Following the insertion of the endoscope, a retraction stitch will be passed through the
 abdominal wall and into the gallbladder to retract the fundus of the gallbladder in a
 cephalad direction. A 5-mm trocar will be placed in the umbilicus and will serve two
 functions: one, to allow for a laparoscope in case the view becomes compromised or
 substandard; and two, to allow a clip applier to be placed in the abdomen for clipping the
 cystic artery and cystic duct. Dissection of the gallbladder can commence using endoscopic
 tools and removal of the specimen will be directly through the culdotomy and out through the
 vagina. Utilizing this technique, as many as three surgical incisions can be avoided.

 Postoperatively, the patient will be kept in the hospital overnight. After discharge,
 follow-up examination will be conducted at 3-5 days (by telephone), 1 week, and 6 weeks
 following the procedure to determine the success of the procedure. Longer term follow-up will
 be determined by the patient's overall condition. For at least the first 3 procedures, a
 laparoscopic camera will be available on the sterile field and at least one laparoscopic
 trocar will be employed. As with any operation, we would revert to the next least invasive
 modality should patient safety and/or degree of difficulty dictate that it be so. In this
 case, should we encounter difficulties during transvaginal cholecystectomy, we would have a
 low threshold to revert to laparoscopic cholecystectomy or even to open cholecystectomy as
 needed.

 Safety Monitoring: Due to the novelty of the procedure, safety information will be monitored
 on a continuous basis. Complications that deviate from expected outcomes from standard
 laparoscopic cholecystectomy would result in, the study being terminated prematurely or
 temporarily suspended while we assess the events. A member of the general surgery department
 will be appointed as a safety monitor and will review all the cases and report to the IRB
 after the first and third case.

 Risks and Benefits: The anticipated risks associated with this type of surgery include:

 Bleeding, infection, need for open surgery, bile leak, bile duct injury, and bowel injury.
 Risks specific to the transvaginal NOTES approach include infection of the vagina,
 dyspareunia. A vaginal incision has no known adverse effects on either fertility or
 subsequent childbirth, even within a few weeks of the procedure. The anticipated benefits
 include a decrease in the amount of pain experienced with laparoscopic cholecystectomy, as
 well as a more cosmetically acceptable result.

 Statistics: As this is a purely descriptive study of feasibility of a new technique, there
 are no specific statistics to be monitored.

 Data Storage: The identifiable data collected will be kept in a locked filing cabinet in the
 primary investigator's office. Only the PI will have access to this file.

 It is anticipated that there will be more similar "natural orifice-type" surgeries in the
 future for a variety of procedures and a multitude of reasons (no incision, less pain, and
 less time in the hospital). These surgeries will be some of the first transvaginal
 cholecystectomies performed in the world.
Inclusion Criteria:

 1. Adult female (18 years old or over) patients who are able to provide informed consent
 for this surgical procedure

 2. Patients scheduled to undergo non-emergent surgical removal of the gallbladder

 Exclusion Criteria:

 1. Inability to provide informed consent

 2. Patients who have a history of prior pelvic surgery (excluding Caesarian sections,
 tubal ligations, or non-operative pelviscopy)

 3. Patients who have acute cholecystitis, gallstone pancreatitis, or who have had a
 percutaneous cholecystotomy tube placed

 4. Patients with a BMI > 40 kg/m2

 5. Pregnancy

 6. Male gender

 7. History of PID