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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

Tracking Information
First Submitted Date  ICMJE January 25, 2014
First Posted Date  ICMJE January 30, 2014
Last Update Posted Date January 30, 2014
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2014)
  • Morbidity/Mortality [ Time Frame: 1 month ]
  • Effect of the procedure on weight loss [ Time Frame: 1 year ]
    Evaluation at 1,3,6 and 12 months through clinical evaluation.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2014)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of Laparoscopic Non Banded Vertical Gastroplasty in Bariatric Surgery
Official Title  ICMJE Laparoscopic Non Banded Vertical (Magenstrasse and Mill) Gastroplasty In Bariatric Surgery. Morbidity and Results on Weight Loss and Associated Co-morbidities
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Laparoscopic Vertical Gastroplasty
Intervention: Procedure: Laparoscopic Vertical Gastroplasty
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: January 28, 2014)
100
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2014
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02050477
Other Study ID Numbers  ICMJE B707201214181
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arnaud De Roover, University of Liege
Study Sponsor  ICMJE University of Liege
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arnaud De Roover, MD Dept of Abdominal Surgery and Transplantation CHU Liège Belgium
PRS Account University of Liege
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP