View Clinical Trial (Medical Research Study)
Minimally Invasive Surgery: Using Natural Orifice Translumenal Endoscopic Surgery (NOTES) - NCT00531219-92103(Clinical Trial 185291)
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San Diego |
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State:
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CA |
| Zip Code: |
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92103 |
| Conditions: |
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Appendicitis - Cholelithiasis |
| Purpose: |
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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 openings in the abdomen; place a camera and other instruments, and
remove 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 would like to perform this investigational method of
surgery through the mouth.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
Inclusion criteria for the Group #1 transgastric appendectomy:
1. Males and females between the ages of 18-50
2. Clinical diagnosis of appendicitis emergency room evaluation within 36 hours of the
onset of pain
3. ASA classification I
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 with severe medical comorbidities who not ASA class I or II will be excluded
5. Patients who are on proton pump inhibitors (PPI)
6. Patients with evidence of an abdominal abscess or mass on CT scan
7. Patients who present with a clinical diagnosis of sepsis
8. Patients who have a history of open abdominal surgery
9. Patients with diffuse peritonitis on clinical examination
10. Patients on blood thinners, aspirin, or patients with other coagulation abnormalities
Inclusion criteria for Group #2 transgastric cholecystectomy:
1. Males and females between the ages of 18 -50
2. Diagnosis of gallstone disease that require cholecystectomy
3. ASA classification I
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 with severe medical comorbidities
5. Patients who are on proton pump inhibitors (PPI)
6. Patients with suspicion of gallbladder cancer
7. Patients with a history of open abdominal surgery
8. Patients with known common bile duct stones (gallstones are not limited to the
gallbladder)
9. Patients on blood thinners or aspirin |
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| Study is available at: |
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University of California, San Diego
San Diego, CA 92103
United States
Primary Contact:
Julie A Bosia, BSN
Email: misresearch@ucsd.edu
Phone: 619-471-0447 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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