Clinical Study of Laparoscopic Non Banded Vertical Gastroplasty in Bariatric Surgery
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|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
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Procedure: Laparoscopic Vertical Gastroplasty||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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.
- 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
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
|Dept of Abdominal Surgery and Transplantation, CHU Liège|
|Liège, Belgium, 4000|
|Principal Investigator:||Arnaud De Roover, MD||Dept of Abdominal Surgery and Transplantation CHU Liège Belgium|