Minimally Invasive Surgery: Using Natural Orifice Translumenal Endoscopic Surgery (NOTES)
NCT ID: NCT00531219
Last Updated: 2018-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2008-02-29
2020-02-29
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Group #1 NOTES Appendectomy - Transgastric approach
Transgastric Appendectomy
The appendix will be removed through an incision in the stomach and pulled out through the mouth
2
Group #2 NOTES Cholecystectomy - Transgastric approach
Transgastric Cholecystectomy
The gallbladder will be removed through an incision in the stomach and pulled out through the mouth.
Interventions
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Transgastric Appendectomy
The appendix will be removed through an incision in the stomach and pulled out through the mouth
Transgastric Cholecystectomy
The gallbladder will be removed through an incision in the stomach and pulled out through the mouth.
Eligibility Criteria
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Inclusion Criteria
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.
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
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
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
18 Years
75 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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Santiago Horgan
Professor of Surgery
Principal Investigators
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Santiago Horgan, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of California, San Diego
San Diego, California, United States
Countries
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Central Contacts
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Other Identifiers
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071114, 140016
Identifier Type: -
Identifier Source: org_study_id
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