Omentectomy and Metabolic Syndrome

Study Overview
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Brief Summary
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The aim of the present study was to evaluate the additional effect of sudden visceral fat reduction by omentectomy on Metabolic Syndrome, acute phase reactants and inflammatory mediators in patients with morbid obesity undergoing Laparoscopic Roux-en-Y Gastric Bypass.

Detailed Description
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Although weight loss controls Metabolic Syndrome and reduces the level of inflammatory markers in patients with Morbid Obesity, patients may enjoy the benefit achieving metabolic control before significant weight loss occurs.

Official Title
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Effect of Omentectomy on Metabolic Syndrome, Acute Phase Reactants & Inflammatory Mediators in Patients Undergoing LRYGBP: A Randomized Trial

Conditions
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Metabolic Syndrome, Morbid Obesity

Intervention / Treatment
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* Procedure: Laparoscopic Roux-en-Y Gastric Bypass
* Procedure: Omentectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > 35 Kg/m2 Metabolic syndrome diagnosed Exclusion Criteria: Type 1 diabetes Uncontrolled type 2 diabetes Cirrhosis or active hepatitis Pregnancy Recent MI or stroke

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Roux-en-Y Gastric Bypass/Omentectomy<br>Laparoscopic Roux-en-Y Gastric Bypass with omentectomy | Procedure: Laparoscopic Roux-en-Y Gastric Bypass<br>* Laparoscopic Roux-en-Y Gastric Bypass was performed according to the following standards: Gastric pouch was constructed using the lesser curvature of the stomach. A 45mm stapler was initially fired horizontally 2 to 3 cm below the gastroesophageal junction and then 2 o 3 additional fires towards the angle of His and against a 32 French intragastric tube completed the vertical transection. Lengths of the biliopancreatic and alimentary limbs were approximately 50, and 150 cm respectively. An antecolic and antegastric gastrojejunostomy, 1.0 to 1.5 cm in size was hand sewn and the jejuno-jejunostomy was completed in a latero-lateral fashion using one fire of 45 mm lineal stapler with hand sewn closure of the common enterotomy.<br>Procedure: Omentectomy<br>* After laparoscopic gastric bypass, the greater omentum was divided in the middle from the free edge to the colonic margin using ultrasonic energy. Attachments between the omentum and the transverse colon were dissected. The omentum was detached from the stomach transecting the vessels between the right gastroepiploic vessels and the greater curvature of the stomach. Once the omentum was freed from the stomach, the duodenum and the lower pole of the spleen, it was extracted from the abdominal cavity in a sterile plastic bag.<br>|
| Active Comparator: Roux-en-Y Gastric Bypass alone<br> | Procedure: Laparoscopic Roux-en-Y Gastric Bypass<br>* Laparoscopic Roux-en-Y Gastric Bypass was performed according to the following standards: Gastric pouch was constructed using the lesser curvature of the stomach. A 45mm stapler was initially fired horizontally 2 to 3 cm below the gastroesophageal junction and then 2 o 3 additional fires towards the angle of His and against a 32 French intragastric tube completed the vertical transection. Lengths of the biliopancreatic and alimentary limbs were approximately 50, and 150 cm respectively. An antecolic and antegastric gastrojejunostomy, 1.0 to 1.5 cm in size was hand sewn and the jejuno-jejunostomy was completed in a latero-lateral fashion using one fire of 45 mm lineal stapler with hand sewn closure of the common enterotomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Components of Metabolic Syndrome (Body Mass Index) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | Basal | 
| Components of Metabolic Syndrome (Body Mass Index) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 month | 
| Components of Metabolic Syndrome (Body Mass Index) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 3 months | 
| Components of Metabolic Syndrome (Body Mass Index) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 6 months | 
| Components of Metabolic Syndrome (Body Mass Index) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 year | 
| Components of Metabolic Syndrome (Systolic Blood Pressure) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | Basal | 
| Components of Metabolic Syndrome (Systolic Blood Pressure) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 month | 
| Components of Metabolic Syndrome (Systolic Blood Pressure) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 3 months | 
| Components of Metabolic Syndrome (Systolic Blood Pressure) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 6 months | 
| Components of Metabolic Syndrome (Systolic Blood Pressure) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 year | 
| Components of Metabolic Syndrome (Diastolic Blood Pressure) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | Basal | 
| Components of Metabolic Syndrome (Diastolic Blood Pressure) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 month | 
| Components of Metabolic Syndrome (Diastolic Blood Pressure) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 3 months | 
| Components of Metabolic Syndrome (Diastolic Blood Pressure) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 6 months | 
| Components of Metabolic Syndrome (Diastolic Blood Pressure) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 year | 
| Components of Metabolic Syndrome (Glucose) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | Basal | 
| Components of Metabolic Syndrome (Glucose) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 month | 
| Components of Metabolic Syndrome (Glucose) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 3 months | 
| Components of Metabolic Syndrome (Glucose) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 6 months | 
| Components of Metabolic Syndrome (Glucose) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 year | 
| Components of Metabolic Syndrome (Insulin) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | Basal | 
| Components of Metabolic Syndrome (Insulin) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 3 months | 
| Components of Metabolic Syndrome (Insulin) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 6 months | 
| Components of Metabolic Syndrome (Insulin) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 year | 
| Components of Metabolic Syndrome (Total Cholesterol) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | Basal | 
| Components of Metabolic Syndrome (Total Cholesterol) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 month | 
| Components of Metabolic Syndrome (Total Cholesterol) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 3 months | 
| Components of Metabolic Syndrome (Total Cholesterol) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 6 months | 
| Components of Metabolic Syndrome (Total Cholesterol) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 year | 
| Components of Metabolic Syndrome (Triglycerides) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | Basal | 
| Components of Metabolic Syndrome (Triglycerides) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 month | 
| Components of Metabolic Syndrome (Triglycerides) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 3 months | 
| Components of Metabolic Syndrome (Triglycerides) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 6 months | 
| Components of Metabolic Syndrome (Triglycerides) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 year | 
| Components of Metabolic Syndrome (Low-Density Lipoproteins) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | Basal | 
| Components of Metabolic Syndrome (Low-Density Lipoproteins) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 month | 
| Components of Metabolic Syndrome (Low-Density Lipoproteins) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 3 months | 
| Components of Metabolic Syndrome (Low-Density Lipoproteins) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 6 months | 
| Components of Metabolic Syndrome (Low-Density Lipoproteins) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 year | 
| Components of Metabolic Syndrome (High-Density Lipoproteins) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | Basal | 
| Components of Metabolic Syndrome (High-Density Lipoproteins) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 month | 
| Components of Metabolic Syndrome (High-Density Lipoproteins) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 3 months | 
| Components of Metabolic Syndrome (High-Density Lipoproteins) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 6 months | 
| Components of Metabolic Syndrome (High-Density Lipoproteins) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement | Basal | 
| Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 3 months | 
| Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 6 months | 
| Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 year | 
| Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement | Basal | 
| Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 3 months | 
| Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 6 months | 
| Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement | 1 year | 
| Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | Basal | 
| Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 3 months | 
| Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement | 6 months | 
| Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 year | 
| Acute Phase Reactants and Inflammatory Mediators (Leptin) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | Basal | 
| Acute Phase Reactants and Inflammatory Mediators (Leptin) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 3 months | 
| Acute Phase Reactants and Inflammatory Mediators (Leptin) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 6 months | 
| Acute Phase Reactants and Inflammatory Mediators (Leptin) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 year | 
| Acute Phase Reactants and Inflammatory Mediators (Adiponectin) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | Basal | 
| Acute Phase Reactants and Inflammatory Mediators (Adiponectin) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 3 months | 
| Acute Phase Reactants and Inflammatory Mediators (Adiponectin) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 6 months | 
| Acute Phase Reactants and Inflammatory Mediators (Adiponectin) | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omentectomy, metabolic syndrome, acute phase reactants