Clinical Study of Laparoscopic Non Banded Vertical Gastroplasty in Bariatric Surgery

Phase 4UnknownNCT02050477

University of Liege100 enrolled

Overview

Evaluation of the laparoscopic approach of the Magenstrasse and Mill procedure in a prospective study of 100 patients

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Obesity

Interventions

Laparoscopic Vertical GastroplastyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Dept of Abdominal Surgery and Transplantation, CHU Liège

Liège, Liège, Belgium

Outcomes

Primary Outcomes

Morbidity/Mortality

Time frame: 1 month

Effect of the procedure on weight loss

Evaluation at 1,3,6 and 12 months through clinical evaluation.

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 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

Time frame: 1 year

Data from ClinicalTrials.gov

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