Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg
Strasbourg, 67000, France
NCT Number: NCT02948621
The endoscopic sleeve gastroplasty allows stomach size reduction through an endoluminal suture approach without any incision. It could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement.
The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity.
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Notify Me18 year–60 year
All sexes
Observational
Strasbourg, 67000, France
Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. Nowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. This could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement.
The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity according to the technique described in the literature: reduction of the gastric pouch into a sleeve structure by modification of the stomach greater curvature thanks to a plication.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Endoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device (Overstitch, Apollo Endosurgery, Austin, Tx. USA). Continuous stitches are placed to create a sleeve-shaped gastric path of 2 cm diameter to reduce stomach volume from the proximal antrum to the oeso-gastric junction.
Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Time frame: 7 days, 1 - 3 - 6 - 9 and 12 months after procedure
Absence of adverse event within 12 months after procedure.
Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Improvement of hyperlipidemia, arterial hypertension, diabetes, reflux, osteoarticular disorders compared with preoperative data.
Time frame: 3 - 12 - 18 and 24 months after procedure
Improvement of quality of life assessed by Moorehead-Ardelt Quality of life II questionnaire and Gastro-intestinal Quality of Life Index questionnaire.
Time frame: 1 - 3 - 6 - 12 - 18 and 24 months after procedure
Satiety assessed by Three Factors Eating Questionnaire - R18.
IHU Strasbourg
Other
Acronym: Endosleeve
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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