Minimally Invasive Surgery: Using Natural Orfices (NOTES)

A research study to find out more about an investigational approach to perform surgery that has not been done in humans before at this institution. Normally this type of surgery would be done laparoscopically or open. Laparoscopic surgery is where the doctor would make several (3-6) small opening in the abdomen; places a camera and other instruments and removes the gallbladder through a small incision in the lower right abdomen. Open surgery is where the doctor makes approximately a 6 inch incision into the abdomen and removes the gallbladder. This investigational procedure is called Natural Orifice Translumenal Endoscopic Surgery (NOTES). This means that surgery would be done through the mouth, vagina or rectum. In this study, the doctor will perform this investigational method of surgery through the vagina.

• Appendicitis
• Cholelithiasis
• Gallstones

• Procedure: Transvaginal Appendectomy
  The appendix will be removed via an incision in the vagina.
• Procedure: Transvaginal Cholecystectomy
  The gallbladder will be removed via an incision in the vagina.

• Active Comparator: 1
  Group #1 NOTES Appendectomy - Transvaginal approach
  Intervention: Procedure: Transvaginal Appendectomy
• Active Comparator: 2
  Group #2 NOTES Cholecystectomy - Transvaginal approach
  Intervention: Procedure: Transvaginal Cholecystectomy

Inclusion Criteria:

• Group #1 NOTES Appendectomy - Transvaginal approach:

Inclusion criteria for transvaginal appendectomy:

1. Females between the ages of 18-65.
2. Clinical diagnosis of appendicitis
3. Emergency room evaluation within 48 hours of the onset of pain
4. ASA Classification 1

Exclusion criteria for transvaginal appendectomy:

1. Pregnant women (need to have negative icon in ER)
2. Morbidly obese patients (BMI >35)
3. Patients who are taking immunosuppressive medications or are immunocompromised
4. Patients with evidence of an abdominal abscess or mass
5. Patients who present with a clinical diagnosis of sepsis or peritonitis
6. Patients who have a history of prior open abdominal surgery or prior transvaginal surgery. Patients with prior laparoscopic surgery will be included.
7. Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
8. Patients with diffuse peritonitis on clinical exam
9. Previous trauma to the perineal area
10. Patients on blood thinners or aspirin or abnormal blood coagulation tests.

Group #2 NOTES Cholecystectomy - Transvaginal approach:

Inclusion criteria for transvaginal cholecystectomy:

1. Females between the ages of 18 and 65
2. Diagnosis of gallstone disease which requires cholecystectomy
3. ASA class 1

Exclusion criteria for transvaginal cholecystectomy:

1. Pregnant women
2. Morbidly obese patients (BMI > 35)
3. Patients who are taking immunosuppressive medications and/or immunocompromised
4. Patients with severe medical comorbidities will be excluded.
5. Patients with a presumed gallbladder polyps, mass or tumor
6. Patients with a history of prior open abdominal or transvaginal surgery. Patients with prior laparoscopic surgery will be included.
7. Patients with a prior history of peritoneal or vaginal trauma
8. Patients with a history of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis
9. Patients with known common bile duct stones
10. Patients on blood thinners or aspirin or abnormal blood coagulation tests