Clinical Study of Laparoscopic Non Banded Vertical Gastroplasty in Bariatric Surgery

Phase 4

• Conditions: Obesity
• Interventions: Procedure: Laparoscopic Vertical Gastroplasty

• Registration Number: NCT02050477
• Lead Sponsor: University of Liege

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.

Study Timeline

• Study Start: 2012-06
• Status Verified: 2014-01
• Study First Submitted: 2014-01-25
• Study First Submitted QC: 2014-01-28
• Last Update Submitted: 2014-01-28
• Study First Posted: 2014-01-30
• Last Update Posted: 2014-01-30
• Primary Completion: 2014-07
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic Vertical Gastroplasty	Laparoscopic Vertical Gastroplasty	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dept of Abdominal Surgery and Transplantation, CHU Liège; 🇧🇪 Liège, Belgium