Clinical Study of Laparoscopic Non Banded Vertical Gastroplasty in Bariatric Surgery
Laparoscopic Non Banded Vertical (Magenstrasse and Mill) Gastroplasty In Bariatric Surgery. Morbidity and Results on Weight Loss and Associated Co-morbidities
1 other identifier
interventional
100
1 country
1
Brief Summary
Evaluation of the laparoscopic approach of the Magenstrasse and Mill procedure in a prospective study of 100 patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 obesity
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 25, 2014
CompletedFirst Posted
Study publicly available on registry
January 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJanuary 30, 2014
January 1, 2014
2.1 years
January 25, 2014
January 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Morbidity/Mortality
1 month
Effect of the procedure on weight loss
Evaluation at 1,3,6 and 12 months through clinical evaluation.
1 year
Secondary Outcomes (2)
Reflux disease
1 year
Effect of procedure on obesity associated co-morbidities
1 year
Study Arms (1)
Laparoscopic Vertical Gastroplasty
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept of Abdominal Surgery and Transplantation, CHU Liège
Liège, Liège, 4000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arnaud De Roover, MD
Dept of Abdominal Surgery and Transplantation CHU Liège Belgium
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professeur de Clinique, Chef de Clinique
Study Record Dates
First Submitted
January 25, 2014
First Posted
January 30, 2014
Study Start
June 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
January 30, 2014
Record last verified: 2014-01