Evaluation of Endostapled Anastomoses for Laparoscopic Gastric Bypass (EEA-LGB)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hand-sewn and Linear-stapled Roux-en-Y Gastric Bypass: Outcomes

NCT03199352

Roux-en-y Anastomosis Site

WITHDRAWN

Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery

NCT03968757

Roux-en-Y Gastric Bypass Obesity

COMPLETED

A Post-market Observational Study With the easyEndoTM Universal Linear Cutting Stapler in Standard Laparoscopic and Robot-assisted Laparoscopic Roux-en-Y Gastric Bypass (RYGB) Surgery

NCT04543526

Obesity Roux-en-Y Gastric Bypass

WITHDRAWN

Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass

NCT01504685

Morbid Obesity

COMPLETED NA

A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy

NCT04808206

Obesity Roux-en-Y Gastric Bypass Gastrostomy +1 more

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Morbid Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Smaller Stapler

3.5 mm Circular Stapler

Group Type ACTIVE_COMPARATOR

3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass

Intervention Type 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.

Larger Stapler

4.8 mm Circular Stapler

Group Type ACTIVE_COMPARATOR

3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

3.5 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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Covidien small 3.5 mm Circular Stapler Covidien large 4.8 mm Circular Stapler

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No