Minimally Invasive Surgery: Using Natural Orifice Translumenal Endoscopic Surgery (NOTES)
Minimally Invasive Surgery: Using Natural Orifice Translumenal Endoscopic Surgery (NOTES)
This is an observational study of pain and outcomes from patients undergoing transgastric
 NOTES removal of their appendix or gallbladder. Subjects who elect to have a transgastric
 NOTES removal of their appendix or gallbladder and agree to be in this study (through
 signature on the informed consent form) will be followed per standard of care, with
 additional follow-up for data collection including the following:

 -  Subjects will complete a 7 day pain/temperature log after surgery

 -  Subjects will receive a phone call at 6 months and at 1 year after surgery to capture
 data related to safety, adverse events, hospitalizations and patient satisfaction

 Additional data related to pain and outcomes will be collected at baseline/screening and at
 follow-up as necessary.
Inclusion criteria for the Group #1 transgastric appendectomy:

 1. Males and Females between the ages of 18-75

 2. Clinical diagnosis of appendicitis Emergency room evaluation within 36 hours of the
 onset of pain

 3. ASA classification I

 4. Mentally competent to give informed consent.

 5. Scheduled to undergo a transgastric NOTES appendectomy.

 Exclusion criteria for group #1 transgastric appendectomy:

 1. Pregnant women

 2. Morbidly obese patients (Body mass index > 35)

 3. Patients who are taking immunosuppressive medications or are immunocompromised

 4. Patients who are on Proton Pump Inhibitors (PPI)

 5. Patients with evidence of an abdominal abscess or mass on CT scan

 6. Patients who present with a clinical diagnosis of sepsis

 7. Patients who have a history of open abdominal surgery

 8. Patients with diffuse peritonitis

 9. Patients on blood thinners or aspirin

 Inclusion criteria for Group #2 transgastric cholecystectomy:

 1. Males and Females between the ages of 18 -75

 2. Diagnosis of gallstone disease that require cholecystectomy

 3. ASA classification I

 4. Mentally competent to give informed consent.

 5. Scheduled to undergo a transgastric NOTES cholecystectomy.

 Exclusion criteria for Group #2 transgastric cholecystectomy:

 1. Pregnant women

 2. Patients with a Body mass index > 35

 3. Patients who are taking immunosuppressive medications or are immunocompromised

 4. Patients who are on Proton Pump Inhibitors (PPI)

 5. Patients with suspicion of gallbladder cancer

 6. Patients with a history of open abdominal surgery

 7. Patients with known common bile duct stones (gallstones are not limited to the
 gallbladder)

 8. Patients on blood thinners or aspirin