Appendicitis, Cholelithiasis
Conditions
Keywords
appendicitis, cholelithiasis, gallstones
Brief summary
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.
Interventions
PROCEDURETransgastric Appendectomy
The appendix will be removed through an incision in the stomach and pulled out through the mouth
PROCEDURETransgastric Cholecystectomy
The gallbladder will be removed through an incision in the stomach and pulled out through the mouth.
Sponsors
University of California, San Diego
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and efficacy of transgastric NOTES appendectomies and cholecystectomies (through data collection). | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate pain associated with the transgastric approach (through data collection). | 1 year |
Countries
United States
Contacts
Primary ContactSarah Lazar, MPH
Outcome results
None listed