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| ID | Type | Description | Link |
|---|---|---|---|
| SPA 38461 |
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| Name | Class |
|---|---|
| United States Surgical Corporation | OTHER |
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Laparoscopic gastric bypass surgery is a common procedure being performed for the treatment of morbid obesity. The procedure consists of a creation of a small gastric pouch and rerouting the small bowel to bypass the stomach and duodenum. There are two anastomoses in this procedure: the gastrojejunostomy and the jejunojejunostomy. Potential complications after gastric bypass include gastrointestinal bleeding and leaks. Gastrointestinal bleeding can occur at any staple line including the gastrojejunostomy. Potential methods for prevention of postoperative gastrointestinal bleeding include oversewing of the anastomosis or the use of a smaller stapler height. We hypothesize that the use of staplers with smaller staple height will significantly result in a lower rate of staple line bleeding and possible leaks.
RATIONALE:
HYPOTHESES:
The smaller circular stapler may be associated with a lower rate of intraoperative intraluminal bleeding and postoperative gastrointestinal bleeding than the larger one.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smaller Stapler | Active Comparator | 3.5 mm Circular Stapler |
|
| Larger Stapler | Active Comparator | 4.8 mm Circular Stapler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass | Procedure | The procedure consists of a creation of a small gastric pouch and rerouting the small bowel to bypass the stomach and duodenum. There are two anastomoses in this procedure: the gastrojejunostomy and the jejunojejunostomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postoperative Gastrointestinal Hemorrhage | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
large abdominal ventral hernia
large hiatal hernia,
history of liver cirrhosis
history of venous thrombosis or pulmonary embolism, coagulopathy or
Pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Ninh T Nguyen, MD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine Medical Center | Orange | California | 92868 | United States | ||
| Tampa General Hospital- University of South Florida |
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Patients were recruited within bariatric surgery clinic at each institution
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| ID | Title | Description |
|---|---|---|
| FG000 | Smaller Stapler | 3.5 mm Circular Stapler |
| FG001 | Larger Stapler | 4.8 mm Circular Stapler |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Smaller Stapler | 3.5 mm Circular Stapler |
| BG001 | Larger Stapler | 4.8 mm Circular Stapler |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Postoperative Gastrointestinal Hemorrhage | Posted | Nov 2009 | Number | participants | 30 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Smaller Stapler | 3.5 mm Circular Stapler |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute renal failure | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ninh T. Nguyen, M.D. | UC Irvine Medical Center | 714-456-8580 | ninhn@uci.edu |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
|
| Tampa |
| Florida |
| 33601 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| New York Presbyterian Hospital-Weill Cornell Medical Center | New York | New York | 10021 | United States |
| Ohio State University | Columbus | Ohio | 43210-1228 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390-9156 | United States |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 5 |
| 180 |
| 33 |
| 180 |
| EG001 | Larger Stapler | 4.8 mm Circular Stapler | 14 | 175 | 52 | 175 |
| anastomotic leak/intraadbdominal abscess | Gastrointestinal disorders | Systematic Assessment |
|
| myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| GI obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| pneumonia | Immune system disorders | Systematic Assessment |
|
| pulmonary embolism | General disorders | Systematic Assessment |
|
| GI hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| anastomotic stricture | Gastrointestinal disorders | Systematic Assessment |
|
| cardiac arrhythmia | Cardiac disorders | Systematic Assessment |
|
| superficial wound infection | General disorders | Systematic Assessment |
|
| prolonged diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| peripheral neuropathy/parethesia | General disorders | Systematic Assessment |
|
| marginal ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| dehydration | General disorders | Systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |