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

Study Overview
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Brief Summary
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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
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Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transgastric Appendectomy and Cholecystectomy

Conditions
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Appendicitis, Cholelithiasis

Intervention / Treatment
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* Procedure: Transgastric Appendectomy
* Procedure: Transgastric Cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for the Group #1 transgastric appendectomy: Males and Females between the ages of 18-75 Clinical diagnosis of appendicitis Emergency room evaluation within 36 hours of the onset of pain ASA classification I Mentally competent to give informed consent. Scheduled to undergo a transgastric NOTES appendectomy. Exclusion criteria for group #1 transgastric appendectomy: Pregnant women Morbidly obese patients (Body mass index > 35) Patients who are taking immunosuppressive medications or are immunocompromised Patients who are on Proton Pump Inhibitors (PPI) Patients with evidence of an abdominal abscess or mass on CT scan Patients who present with a clinical diagnosis of sepsis Patients who have a history of open abdominal surgery Patients with diffuse peritonitis Patients on blood thinners or aspirin Inclusion criteria for Group #2 transgastric cholecystectomy: Males and Females between the ages of 18 -75 Diagnosis of gallstone disease that require cholecystectomy ASA classification I Mentally competent to give informed consent. Scheduled to undergo a transgastric NOTES cholecystectomy. Exclusion criteria for Group #2 transgastric cholecystectomy: Pregnant women Patients with a Body mass index > 35 Patients who are taking immunosuppressive medications or are immunocompromised Patients who are on Proton Pump Inhibitors (PPI) Patients with suspicion of gallbladder cancer Patients with a history of open abdominal surgery Patients with known common bile duct stones (gallstones are not limited to the gallbladder) Patients on blood thinners or aspirin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Group #1 NOTES Appendectomy - Transgastric approach | Procedure: Transgastric Appendectomy<br>* The appendix will be removed through an incision in the stomach and pulled out through the mouth<br>|
| 2<br>Group #2 NOTES Cholecystectomy - Transgastric approach | Procedure: Transgastric Cholecystectomy<br>* The gallbladder will be removed through an incision in the stomach and pulled out through the mouth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and efficacy of transgastric NOTES appendectomies and cholecystectomies (through data collection). |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate pain associated with the transgastric approach (through data collection). |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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appendicitis, cholelithiasis, gallstones