Clinical Study of Laparoscopic Non Banded Vertical Gastroplasty in Bariatric Surgery

Obesity Clinical Trial

Official title:

Laparoscopic Non Banded Vertical (Magenstrasse and Mill) Gastroplasty In Bariatric Surgery. Morbidity and Results on Weight Loss and Associated Co-morbidities

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02050477
• Other study ID #: B707201214181
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 25, 2014
• Last updated: January 28, 2014
• Start date: June 2012
• Est. completion date: July 2014

Study information

• Verified date: January 2014
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Belgium	Dept of Abdominal Surgery and Transplantation, CHU Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity/Mortality		1 month	Yes
Primary	Effect of the procedure on weight loss	Evaluation at 1,3,6 and 12 months through clinical evaluation.	1 year	No
Secondary	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.	1 year	No
Secondary	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	1 year	No