Clinical Study of Laparoscopic Non Banded Vertical Gastroplasty in Bariatric Surgery

University of Liege

Status and phase

Unknown

Phase 4

Conditions

Obesity

Treatments

Procedure: Laparoscopic Vertical Gastroplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT02050477

B707201214181

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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