Morbid Obesity
Conditions
Keywords
Morbid Obesity, Laparoscopic Gastric Bypass, Staple Line Hemorrhage
Brief summary
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.
Detailed description
RATIONALE: 1. Gastrointestinal (GI) bleeding can occur in up to 4% of cases. GI bleeding is associated with significant morbidity which may include transfusion and possible re-operation 2. Leaks at the gastrojejunostomy can be potentially life threatening and ranged from 1% to 2%. HYPOTHESES: The smaller circular stapler may be associated with a lower rate of intraoperative intraluminal bleeding and postoperative gastrointestinal bleeding than the larger one.
Interventions
PROCEDURE3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass
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.
Sponsors
United States Surgical Corporation
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. BMI between 40-60 kg/m2 2. BMI of 35 kg/m2 with comorbidities
Exclusion criteria
1. large abdominal ventral hernia 2. large hiatal hernia, 3. history of liver cirrhosis 4. history of venous thrombosis or pulmonary embolism, coagulopathy or 5. Pregnant women * All physician, hospital, surgery, and laboratory costs will be billed to the subject or their insurance carriers as customary. The 3.5mm circular stapler is an FDA approved product and it will also be billed to the subject or insurer in the customary fashion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Postoperative Gastrointestinal Hemorrhage | 30 days |
Countries
United States
Participant flow
Recruitment details
Patients were recruited within bariatric surgery clinic at each institution
Participants by arm
| Arm | Count |
|---|---|
| Smaller Stapler 3.5 mm Circular Stapler | 180 |
| Larger Stapler 4.8 mm Circular Stapler | 175 |
| Total | 355 |
Baseline characteristics
| Characteristic | Larger Stapler | Smaller Stapler | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 175 Participants | 180 Participants | 355 Participants |
| Age Continuous | 43.1 years STANDARD_DEVIATION 10.1 | 43.1 years STANDARD_DEVIATION 10.8 | 43.1 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 175 participants | 180 participants | 355 participants |
| Sex: Female, Male Female | 138 Participants | 135 Participants | 273 Participants |
| Sex: Female, Male Male | 37 Participants | 45 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 180 | 52 / 175 |
| serious Total, serious adverse events | 5 / 180 | 14 / 175 |
Outcome results
Primary
Number of Participants With Postoperative Gastrointestinal Hemorrhage
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Smaller Stapler | Number of Participants With Postoperative Gastrointestinal Hemorrhage | 13 participants |
| Larger Stapler | Number of Participants With Postoperative Gastrointestinal Hemorrhage | 39 participants |