Summary

for people ages 18-75 (full criteria)
at UCSD
study started
estimated completion
Santiago Horgan (ucsd)

Description

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.

Official Title

Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transgastric Appendectomy and Cholecystectomy

Keywords

Appendicitis Cholelithiasis gallstones Cholecystolithiasis Transgastric Appendectomy Transgastric Cholecystectomy

Eligibility

You can join if…

Open to people ages 18-75

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.

You CAN'T join if...

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

Location

  • University of California, San Diego accepting new patients
    San Diego California 92103 United States

Lead Scientist

  • Santiago Horgan (ucsd)
    Dr. Santiago Horgan is an internationally recognized expert in robot-assisted surgery and other minimally invasive surgical techniques. Dr. Horgan is among the first surgeons trained to perform the Lap-Band Adjustable Gastric Banding System procedure used for the treatment of obesity.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT00531219
Study Type
Observational
Last Updated