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The is a pilot study to evaluate the safety and efficacy of hybrid transvaginal-transabdominal procedures. Diagnostic peritoneoscopy (visualizing the inside of the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the gallbladder) will be performed through a vaginal incision with an additional small incision in the umbilicus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Cholecystectomy | Experimental | 20 patients in this arm will undergo cholecystectomy, or removal of the gallbladder, through this experimental approach. This arm will compose of patients with symptomatic gallstones (cholelithiasis). |
|
| Endoscopic Appendectomy | Experimental | Participants will with chronic appendicitis will undergo appendectomy through this experimental approach. |
|
| Endoscopic Peritoneoscopy | Experimental | 20 patients in this arm will undergo diagnostic peritoneoscopy with or without biopsy for any indication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Cholecystectomy | Procedure | An incision will be made in the vagina and a flexible surgical camera (endoscope) and instruments will be introduced. The surgical procedure for each given arm will be performed with the aid of an additional surgical instrument inserted through a small incision in the umbilicus. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | intra-operative | |
| Complication | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | intra-operative | |
| Sexual function | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julio Teixeira, MD | St. Luke's-Roosevelt Hospital Center, Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's-Roosevelt Hospital Center | New York | New York | 10025 | United States |
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| ID | Term |
|---|---|
| D042882 | Gallstones |
| D001064 | Appendicitis |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
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| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| Endoscopic Appendectomy | Procedure | An incision will be made in the vagina and a flexible surgical camera (endoscope) and instruments will be introduced. The surgical procedure for each given arm will be performed with the aid of an additional surgical instrument inserted through a small incision in the umbilicus |
|
| Endoscopic Peritoneoscopy | Procedure | A diagnostic peritoneoscopy with or without biopsy for any indication |
|
| D005705 |
| Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |