Minimally Invasive Surgery: Using Natural Orifice Translumenal Endoscopic Surgery (NOTES)

University of California San Diego

Status: Unknown

Conditions: Appendicitis; Cholelithiasis

Treatments: Procedure: Transgastric Appendectomy; Procedure: Transgastric Cholecystectomy

Study type: Observational

Funder types: Other

Identifiers

NCT00531219

071114, 140016

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

20 participants in 2 patient groups

1

Description:

Group #1 NOTES Appendectomy - Transgastric approach

Treatment:

Procedure: Transgastric Appendectomy

2

Description:

Group #2 NOTES Cholecystectomy - Transgastric approach

Treatment:

Procedure: Transgastric Cholecystectomy