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| ID | Type | Description | Link |
|---|---|---|---|
| Project 60009927 | |||
| Award GRT00006515 | |||
| IRB 2007H0045 |
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| Name | Class |
|---|---|
| Stryker SA | INDUSTRY |
| Natural Orifice Surgery Consortium for Assessment and Research | OTHER |
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During surgery for obesity, minimally invasive endoscopy can be performed and can assist the surgeon in determining surgical incision sites.
Transgastric endoscopic access, without laparoscopic guidance, to the peritoneal cavity can be performed safely and guide trocar placement in morbidly obese patients undergoing Roux-en-y gastric bypass.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 10 patients with no previous abdominal surgeries, pre-insufflation of the abdomen using a veress needle (standard procedure for insufflating the abdomen for laparoscopic surgery) |
|
| 2 | Active Comparator | 10 patients with history of previous abdominal surgeries, pre-insufflation of the abdomen using veress needle (standard procedure for insufflating the abdomen for laparoscopic surgery) |
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| 3 | Active Comparator | 10 patients with no previous history of abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically) |
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| 4 | Active Comparator | 10 patients with history of previous abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically) |
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| 5 | Active Comparator | 10 patients, all with no previous mid to upper abdominal surgeries, no Veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transgastric access to the abdomen | Procedure | Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The achievement of safe transgastric access to the abdomen; the ability to visualize the abdominal wall to assist in safe trocar placement in the morbidly obese patient. | At surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial contamination analysis; results compared to previous study. | Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey W Hazey, MD | The Ohio State University Medical Center/Center for Minimally Invasive Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Medical Center/Center for Minimally Invasive Surgery | Columbus | Ohio | 43210 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 6 | Active Comparator | 10 patients, all with previous mid-to-upper abdominal surgeries, no Veress needle pre-insufflation, endoscopic take-down of intra-abdominal adhesions (if identified) |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |