Prospective Multicenter Human Randomized Controlled Evaluation of NOTES® Cholecystectomy

Inclusion Criteria:

• Competent male or female subjects, between the ages of 18-75 and who present for elective cholecystectomy will be offered participation in this study.
• Male subjects must be willing to have the cholecystectomy by either the laparoscopic or transgastric NOTES approach.
• Female subjects must be willing to have the cholecystectomy by either the laparoscopic or either the NOTES approaches (transgastric and/or transvaginal) being performed at the site.
• Patients offered participation in this study must provide written, informed consent and meet the following criteria prior to randomization.
• Diagnosis of benign gallstone disease which requires cholecystectomy.
• ASA Class 1 or 2.
• Willingness to have laparoscopic cholecystectomy performed and have research data collected for control group.
• Willingness to have abdomen photographed (for cosmesis assessment).

• For sites performing transgastric NOTES approach

  • Willingness to have cholecystectomy performed via NOTES transgastric approach.
  • Willingness to have NOTES procedure videotaped.

• For sites performing transvaginal NOTES approach - Female subjects only

  • Willingness to have cholecystectomy performed via NOTES transvaginal approach.
  • Willingness to have intra-abdominal procedure digitally recorded.
  • Pelvic examination in the past 12 months without significant pathology.

Exclusion Criteria:

• Pregnant women.
• Obese patients (BMI > 35).
• Patients with severe medical comorbidities (ie, NOT ASA Class 1 or 2) will be excluded such as:
• Chronic renal failure
• Chronic liver disease
• Congestive heart failure
• Patients with a presumed gallbladder malignancy.
• Patients with a history of prior open abdominal or laparoscopic or transvaginal surgery. However patients with prior appendectomy, tubal ligation or Cesarean section will be included.
• Patients who are taking immunosuppressive medications and/or immunocompromised.
• Patients with a prior history of perineal trauma leading to significant alteration of vaginal anatomy.
• Patients with a history of ectopic pregnancy, pelvic inflammatory disease, large fibroids or severe endometriosis.
• Patients with known common bile duct stones. (ie, not cleared prior to surgery). Patients with common bile duct stones discovered intra-operatively will remain in the study.
• Patients on anticoagulation drugs other than once daily aspirin. Abnormal blood coagulation tests. Minimal abnormalities may be allowed at the discretion of site principal investigator.
• Gallstones> 2.5cm in diameter.
• Presence of untreated esophageal stricture.
• Surgically altered gastric anatomy or severe uncorrected paraesophageal types 2, 3 or 4.
• Unwillingness to consent to NOTES procedure(s).
• Acute cholecystitis or cholangitis

• For sites performing transgastric NOTES approach

  • Contraindicated for esophagogastroduodenoscopy (EGD).
  • Patients with hypersecretory states.