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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:
Additional data related to pain and outcomes will be collected at baseline/screening and at follow-up as necessary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Group #1 NOTES Appendectomy - Transgastric approach |
| |
| 2 | Group #2 NOTES Cholecystectomy - Transgastric approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transgastric Appendectomy | Procedure | The appendix will be removed through an incision in the stomach and pulled out through the mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and efficacy of transgastric NOTES appendectomies and cholecystectomies (through data collection). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate pain associated with the transgastric approach (through data collection). | 1 year |
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Inclusion criteria for the Group #1 transgastric appendectomy:
Exclusion criteria for group #1 transgastric appendectomy:
Inclusion criteria for Group #2 transgastric cholecystectomy:
Exclusion criteria for Group #2 transgastric cholecystectomy:
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There will be 2 groups in this study: Of special note, the inclusion criteria clearly states subjects must be seen within 36 hours of the onset of pain and have an ASA Classification of I. This is intended to avoid obtaining informed consent from a subject who is in severe pain and incapable of making an informed decision, as well as avoid coercion. An ASA Classification of I defines a healthy normal individual.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Lazar, MPH | Contact | 619-471-0447 | misresearch@ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Santiago Horgan, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | Recruiting | San Diego | California | 92103 | United States |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| D002769 | Cholelithiasis |
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| Transgastric Cholecystectomy | Procedure | The gallbladder will be removed through an incision in the stomach and pulled out through the mouth. |
|
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D001660 | Biliary Tract Diseases |
| D041761 | Cholecystolithiasis |
| D005705 | Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |