Overview

This trial is active, not recruiting.

Condition obesity
Treatment laparoscopic vertical gastroplasty
Phase phase 4
Sponsor University Hospital of Liege
Start date June 2012
End date July 2014
Trial size 100 participants
Trial identifier NCT02050477, B707201214181

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.

Primary Outcomes

Measure
Morbidity/Mortality
time frame: 1 month
Effect of the procedure on weight loss
time frame: 1 year

Secondary Outcomes

Measure
Reflux disease
time frame: 1 year
Effect of procedure on obesity associated co-morbidities
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Laparoscopic Non Banded Vertical (Magenstrasse and Mill) Gastroplasty In Bariatric Surgery. Morbidity and Results on Weight Loss and Associated Co-morbidities
Principal investigator Arnaud De Roover, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University Hospital of Liege.