Clinical Study of Laparoscopic Non Banded Vertical Gastroplasty in Bariatric Surgery

NCT ID: NCT02050477

Last Updated: 2014-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-07-31

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic Vertical Gastroplasty

Group Type: EXPERIMENTAL

Laparoscopic Vertical Gastroplasty

Intervention Type: PROCEDURE

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.

Interventions

Laparoscopic 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Arnaud De Roover

Professeur de Clinique, Chef de Clinique

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arnaud De Roover, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Abdominal Surgery and Transplantation CHU Liège Belgium

Locations

Dept of Abdominal Surgery and Transplantation, CHU Liège

Liège, Liège, Belgium

Countries

Belgium

Other Identifiers

B707201214181

Identifier Type: -

Identifier Source: org_study_id