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Clinical Study of Laparoscopic Non Banded Vertical Gastroplasty in Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02050477
Recruitment Status : Unknown
Verified January 2014 by Arnaud De Roover, University of Liege.
Recruitment status was:  Active, not recruiting
First Posted : January 30, 2014
Last Update Posted : January 30, 2014
Sponsor:
Information provided by (Responsible Party):
Arnaud De Roover, University of Liege

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

Condition or disease Intervention/treatment Phase
Obesity Procedure: Laparoscopic Vertical Gastroplasty Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Non Banded Vertical (Magenstrasse and Mill) Gastroplasty In Bariatric Surgery. Morbidity and Results on Weight Loss and Associated Co-morbidities
Study Start Date : June 2012
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Laparoscopic Vertical Gastroplasty 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.




Primary Outcome Measures :
  1. Morbidity/Mortality [ Time Frame: 1 month ]
  2. Effect of the procedure on weight loss [ Time Frame: 1 year ]
    Evaluation at 1,3,6 and 12 months through clinical evaluation.


Secondary Outcome Measures :
  1. Reflux disease [ Time Frame: 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.

  2. Effect of procedure on obesity associated co-morbidities [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050477


Locations
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Belgium
Dept of Abdominal Surgery and Transplantation, CHU Liège
Liège, Belgium, 4000
Sponsors and Collaborators
University of Liege
Investigators
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Principal Investigator: Arnaud De Roover, MD Dept of Abdominal Surgery and Transplantation CHU Liège Belgium

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Responsible Party: Arnaud De Roover, Professeur de Clinique, Chef de Clinique, University of Liege
ClinicalTrials.gov Identifier: NCT02050477    
Other Study ID Numbers: B707201214181
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: January 30, 2014
Last Verified: January 2014
Keywords provided by Arnaud De Roover, University of Liege:
Obesity
Bariatric
Surgery
Sleeve
Gastroplasty
Laparoscopy
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms