Obesity
Conditions
Keywords
Obesity, Bariatric, Surgery, Sleeve, Gastroplasty, Laparoscopy
Brief summary
Evaluation of the laparoscopic approach of the Magenstrasse and Mill procedure in a prospective study of 100 patients
Detailed description
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.
Interventions
PROCEDURELaparoscopic Vertical Gastroplasty
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.
Sponsors
University of Liege
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity/Mortality | 1 month | — |
| Effect of the procedure on weight loss | 1 year | Evaluation at 1,3,6 and 12 months through clinical evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reflux disease | 1 year | 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. |
| Effect of procedure on obesity associated co-morbidities | 1 year | Co-morbidities include diabetes, hypertension, sleep apnea syndrome, dyslipemia Evaluation at 1,3,6 and 12 months through clinical evaluation and blood assessment |
Countries
Belgium
Outcome results
None listed