Clinical Study of Laparoscopic Non Banded Vertical Gastroplasty in Bariatric Surgery

Study Overview
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Brief Summary
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Evaluation of the laparoscopic approach of the Magenstrasse and Mill procedure in a prospective study of 100 patients

Detailed Description
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The laparoscopy is performed under general anesthesia with a 5 ports access under 14mm Hg pressure. After opening of the gastrocolic ligament and division of any adhesions between stomach and pancreas a circular opening is performed at the junction of corpus and antrum of the stomach with a circular stapler. A tubular gastric pouch is then created along a calibration tube at the lesser curvature by a vertical stapling starting from the circular opening to the angle of Hiss.

Official Title
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Laparoscopic Non Banded Vertical (Magenstrasse and Mill) Gastroplasty In Bariatric Surgery. Morbidity and Results on Weight Loss and Associated Co-morbidities

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Laparoscopic Vertical Gastroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Assessment by a multidisciplinary team specialized in bariatric and metabolic surgery including surgeon, endocrinologist, psychologist and/or psychiatrist, dietician BMI>40 BMI>35 with diabetes or sleep apnea syndrome or hypertension treated with 3 drugs for at least one year Male or female patients between 18 and 75 years of age; fertile female patients must use a reliable contraception method; No previous bariatric procedure Informed consent given by patient Exclusion Criteria: Medical contra-indication for a general anesthesia, or abdominal surgery (allergies to anesthetic drugs, cardio-vascular, pulmonary, or renal conditions leading to an unacceptable risk for the procedure Psychological-Psychiatric (boulimia, severe depression, psychotic condition) Non stabilized endocrine disorder, with potential interference on weight and/or diabetic condition Unability to understand goal of the study, plan of treatment and follow-up Large hiatal hernia and/or severe esophageal reflux disease Grazer, Sweet eater behavior

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic Vertical Gastroplasty<br> | Procedure: Laparoscopic Vertical Gastroplasty<br>* The Magenstrasse and Mill procedure is a conservative vertical gastroplasty described in 1987 through a laparotomy. A tubular gastric pouch is created by a vertical stapling extending from the antrum to the angle of Hiss. In this study, we evaluate the laparoscopic technique of the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity/Mortality |  | 1 month | 
| Effect of the procedure on weight loss | Evaluation at 1,3,6 and 12 months through clinical evaluation. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux disease | Evaluation at 1,3,6 and 12 months through clinical evaluation, Gastroscopy if symptoms present. Upper GI opacification at one year will be performed for all patients. | 1 year | 
| Effect of procedure on obesity associated co-morbidities | Co-morbidities include diabetes, hypertension, sleep apnea syndrome, dyslipemia Evaluation at 1,3,6 and 12 months through clinical evaluation and blood assessment | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Obesity, Bariatric, Sleeve, Gastroplasty, Laparoscopy