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This is an observational study of pain and outcomes from females undergoing transvaginal NOTES removal of their appendix or gallbladder. Female subjects who elect to have a transvaginal 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 - Transvaginal approach |
| |
| 2 | Group #2 NOTES Cholecystectomy - Transvaginal approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transvaginal Appendectomy | Procedure | The appendix will be removed via an incision in the vagina. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and efficacy of transvaginal NOTES appendectomies and cholecystectomies (through data collection). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate pain associated with the transvaginal approach (through data collection). | 1 year |
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Inclusion criteria for transvaginal appendectomy:
Exclusion criteria for transvaginal appendectomy:
Inclusion criteria for transvaginal cholecystectomy:
Exclusion criteria for transvaginal cholecystectomy:
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Group #1: NOTES Appendectomy - Transvaginal approach:
Subjects will be female between the ages of 18-75 who present to the emergency room and are subsequently diagnosed with acute appendicitis. Following diagnosis, investigators will determine if the procedure can be completed via the transvaginal approach. If the patient satisfies the listed criteria then researchers will present study information and offer participation.
Group # 2: NOTES Cholecystectomy - Transvaginal approach:
Female subjects, between the ages of 18-75 who present in the UCSD surgery clinic for elective cholecystectomy will be offered participation in this study.
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| 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 | 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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| Transvaginal Cholecystectomy |
| Procedure |
The gallbladder will be removed via an incision in the vagina. |
|
| 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 |