Trial Outcomes & Findings for Evaluation of Endostapled Anastomoses for Laparoscopic Gastric Bypass (EEA-LGB) (NCT NCT00254072)
NCT ID: NCT00254072
Last Updated: 2010-02-18
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
355 participants
Primary outcome timeframe
30 days
Results posted on
2010-02-18
Participant Flow
Patients were recruited within bariatric surgery clinic at each institution
Participant milestones
| Measure |
Smaller Stapler
3.5 mm Circular Stapler
|
Larger Stapler
4.8 mm Circular Stapler
|
|---|---|---|
|
Overall Study
STARTED
|
180
|
175
|
|
Overall Study
COMPLETED
|
180
|
175
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Endostapled Anastomoses for Laparoscopic Gastric Bypass (EEA-LGB)
Baseline characteristics by cohort
| Measure |
Smaller Stapler
n=180 Participants
3.5 mm Circular Stapler
|
Larger Stapler
n=175 Participants
4.8 mm Circular Stapler
|
Total
n=355 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
180 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
355 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
43.1 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
180 participants
n=5 Participants
|
175 participants
n=7 Participants
|
355 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Smaller Stapler
n=180 Participants
3.5 mm Circular Stapler
|
Larger Stapler
n=175 Participants
4.8 mm Circular Stapler
|
|---|---|---|
|
Number of Participants With Postoperative Gastrointestinal Hemorrhage
|
13 participants
|
39 participants
|
Adverse Events
Smaller Stapler
Serious events: 5 serious events
Other events: 33 other events
Deaths: 0 deaths
Larger Stapler
Serious events: 14 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Smaller Stapler
n=180 participants at risk
3.5 mm Circular Stapler
|
Larger Stapler
n=175 participants at risk
4.8 mm Circular Stapler
|
|---|---|---|
|
Gastrointestinal disorders
acute renal failure
|
0.56%
1/180 • Number of events 5
|
0.00%
0/175
|
|
Gastrointestinal disorders
anastomotic leak/intraadbdominal abscess
|
1.1%
2/180 • Number of events 5
|
1.1%
2/175 • Number of events 14
|
|
Cardiac disorders
myocardial infarction
|
0.56%
1/180 • Number of events 5
|
0.00%
0/175
|
|
Gastrointestinal disorders
GI obstruction
|
0.56%
1/180 • Number of events 5
|
2.3%
4/175 • Number of events 14
|
|
Immune system disorders
pneumonia
|
0.00%
0/180
|
0.57%
1/175 • Number of events 14
|
|
General disorders
pulmonary embolism
|
0.00%
0/180
|
1.1%
2/175 • Number of events 14
|
|
Gastrointestinal disorders
GI hemorrhage
|
0.00%
0/180
|
2.9%
5/175 • Number of events 14
|
Other adverse events
| Measure |
Smaller Stapler
n=180 participants at risk
3.5 mm Circular Stapler
|
Larger Stapler
n=175 participants at risk
4.8 mm Circular Stapler
|
|---|---|---|
|
Gastrointestinal disorders
GI hemorrhage
|
3.3%
6/180 • Number of events 33
|
3.4%
6/175 • Number of events 52
|
|
Gastrointestinal disorders
anastomotic stricture
|
3.9%
7/180 • Number of events 33
|
16.0%
28/175 • Number of events 52
|
|
Cardiac disorders
cardiac arrhythmia
|
0.00%
0/180
|
0.57%
1/175 • Number of events 52
|
|
General disorders
superficial wound infection
|
8.9%
16/180 • Number of events 33
|
6.9%
12/175 • Number of events 52
|
|
Gastrointestinal disorders
prolonged diarrhea
|
0.56%
1/180 • Number of events 33
|
0.00%
0/175
|
|
General disorders
peripheral neuropathy/parethesia
|
0.56%
1/180 • Number of events 33
|
0.57%
1/175 • Number of events 52
|
|
Gastrointestinal disorders
marginal ulcer
|
0.56%
1/180 • Number of events 33
|
1.7%
3/175 • Number of events 52
|
|
General disorders
dehydration
|
0.56%
1/180 • Number of events 33
|
1.1%
2/175 • Number of events 52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place