Morbid ObesityEEA-LGBNCT00254072
Evaluation of Endostapled Anastomoses for Laparoscopic Gastric Bypass (EEA-LGB)
A study testing 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass in people with Morbid Obesity, run by University of California, Irvine at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2007to Apr 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI between 40-60 kg/m2
- BMI of 35 kg/m2 with comorbidities
Who cannot join
- large abdominal ventral hernia
- large hiatal hernia,
- history of liver cirrhosis
- history of venous thrombosis or pulmonary embolism, coagulopathy or
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Ohio State University
Columbus, Ohio, 43210-1228
UT Southwestern Medical Center
Dallas, Texas, 75390-9156
New York Presbyterian Hospital-Weill Cornell Medical Center
New York, New York, 10021
University of California, Irvine Medical Center
Orange, California, 92868
Tampa General Hospital- University of South Florida
Tampa, Florida, 33601
About this study
Official title: Evaluation of Endostapled Anastomoses for Laparoscopic Gastric Bypass (EEA-LGB)a Prospective Randomized Comparison of the 3.5 mm vs 4.8 mm Circular Stapler for Creation of the Gastrojejunostomy in Prevention of Staple Line Hemorrhage During Laparoscopic Gastric Bypass
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.
Read the detailed description
RATIONALE:
- 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
- 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.
- Conditions
- Morbid Obesity
- Being tested
- 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass
- Keywords
- Morbid Obesity, Laparoscopic Gastric Bypass, Staple Line Hemorrhage
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric BypassProcedure or surgery
Also called Covidien small 3.5 mm Circular Stapler, Covidien large 4.8 mm Circular Stapler
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.
| Study group | Role | What they receive |
|---|---|---|
| Smaller Stapler | Active comparator | 3.5 mm Circular Stapler Receives: Procedure: 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass |
| Larger Stapler | Active comparator | 4.8 mm Circular Stapler Receives: Procedure: 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Postoperative Gastrointestinal Hemorrhage
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startJan 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Surgical Corporation
- Investigators
- Ninh T Nguyen, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254072
- Sponsor's protocol ID
- HS 2005 4474
- Other IDs
- SPA 38461
- Acronym
- EEA-LGB
- Status last verified
- Feb 2010
- First submitted
- 31 Oct 2005
- Last updated
- 18 Feb 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endostapled Anastomoses for Laparoscopic Gastric Bypass (EEA-LGB)a Prospective Randomized Comparison of the 3.5 mm vs 4.8 mm Circular Stapler for Creation of the Gastrojejunostomy in Prevention of Staple Line Hemorrhage During Laparoscopic Gastric Bypass
- ClinicalTrials.gov ID
- NCT00254072
- Acronym / sponsor ID
- EEA-LGB / HS 2005 4474
- Conditions
- Morbid Obesity
- Keywords
- Morbid Obesity, Laparoscopic Gastric Bypass, Staple Line Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- United States Surgical Corporation
- Study start
- Jan 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Posted 18 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smaller Stapler | Active comparator | Procedure: 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass3.5 mm Circular Stapler |
| Larger Stapler | Active comparator | Procedure: 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass4.8 mm Circular Stapler |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI between 40-60 kg/m2
- BMI of 35 kg/m2 with comorbidities
Key exclusion criteria (6 listed)
- large abdominal ventral hernia
- large hiatal hernia,
- history of liver cirrhosis
- history of venous thrombosis or pulmonary embolism, coagulopathy or
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric BypassAlso: Covidien small 3.5 mm Circular Stapler, Covidien large 4.8 mm Circular StaplerThe 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. | Procedure or surgery | Larger Stapler, Smaller Stapler |
Primary outcome
Number of Participants With Postoperative Gastrointestinal Hemorrhage
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Morbid Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ninh T Nguyen, MD principal investigator
University of California, Irvine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass in people with Morbid Obesity, run by University of California, Irvine at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Postoperative Gastrointestinal Hemorrhage (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2010.