NCT Number: NCT03554902
Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.
The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
Strasbourg, 67091, France
Location status: Recruiting
Antonio D'Urso, MD
SUB_INVESTIGATOR
Michel Vix, MD
CONTACT
Michel Vix, MD
PRINCIPAL_INVESTIGATOR
Silvana Perretta, MD, PhD
CONTACT
Silvana Perretta, MD, PhD
PRINCIPAL_INVESTIGATOR
Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. Despite its advantages (long term weight loss, comorbidities related to obesity improvement…), bariatric surgery is risky. In fact, complications putting the patient into a life-threatening condition can occur. Endoscopic approaches are similar to current surgical methods but less invasive, safer and allow ambulatory care.
Nowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. This leads to similar results (gastric restriction, weight loss, quality of life and comorbidities improvement) compared with standard surgical procedure while reducing the risk of complications.
One of the major benefit of this technique is its reversibility. A new surgical or endoscopic procedure is possible at a later stage.
Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.
The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Endoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA).
Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Change in weight loss measured in kilograms.
Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Change in excess weight loss measured in percentage. Excess weight loss = (weight loss at time point / weight loss goal to reach a body mass index of 25 kg/m²) x 100
Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Change in body mass index variation measured in kg/m².
Time frame: 7 days, 1 - 3 - 6 - 9 and 12 months after procedure
Number of patients with procedure-related adverse event within 12 months after procedure.
Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Improvement of sleep apnea, 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 questionnaire II. Score range from -3.0 to 3.0.
Time frame: 3 - 12 - 18 and 24 months after procedure
Improvement of quality of life assessed by the Gastro-Intestinal Quality of Life Index questionnaire. A global score > 125 is considered as normal.
Time frame: 1 - 3 - 6 - 12 - 18 and 24 months after procedure
Satiety assessed by Three Factors Eating Questionnaire - R18. Three dimensions are assessed. The higher the score is, the more important the dimension is.
Time frame: 1 day, 6 - 12 and 24 months after procedure
Upper GI control series.
Time frame: 6 - 12 and 24 months after procedure
Upper GI control gastroscopy.
Time frame: At time of procedure
Time required to perform the endoscopic gastric tubulization.
Time frame: At time of procedure
Number of stitches put in place during the endoscopic gastric tubulization.
Contact information is provided by the study sponsor or research team.
Michel Vix, MD
CONTACT
Silvana Perretta, MD, PhD
CONTACT
IHU Strasbourg
Other
Acronym: Endosleeve
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT05783466
Body Weight, Body Weight Changes
Pierre-Bénite, France
View Trial DetailsNCT05598840
Body Weight, Body Weight Changes
L'Hospitalet de Llobregat, Barcelona, Spain
View Trial DetailsNCT04197336
Body Weight, Body Weight Changes
Baltimore, Maryland, United States
View Trial DetailsNCT04433338
Bariatric Surgery, Body Weight
Arnhem, Gelderland, Netherlands
View Trial Details