Morbid Obesity
Conditions
Keywords
Endoscopic gastric tubulization, Weight loss, Quality of life
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEndoscopic gastric tubulization
Endoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA).
Sponsors
IHU Strasbourg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for an endoscopic gastric tubulization in the Nouvel Hôpital Civil, Strasbourg, France
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight loss | 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure | Change in weight loss measured in kilograms. |
| Change in excess weight loss | 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 |
| Change in body mass index variation | 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure | Change in body mass index variation measured in kg/m². |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastro-intestinal quality of life improvement | 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. |
| Modification in the feeling of satiety | 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. * Restrained eating: score from 6 to 24 * Uncontrolled eating: score from 9 to 36 * Emotional eating: score from 3 to 12. |
| Upper GI tract radiologic evaluation | 1 day, 6 - 12 and 24 months after procedure | Upper GI control series. |
| Number of patients with procedure-related adverse event | 7 days, 1 - 3 - 6 - 9 and 12 months after procedure | Number of patients with procedure-related adverse event within 12 months after procedure. |
| Procedure duration | At time of procedure | Time required to perform the endoscopic gastric tubulization. |
| Number of stitches in place | At time of procedure | Number of stitches put in place during the endoscopic gastric tubulization. |
| Upper GI tract endoscopic evaluation | 6 - 12 and 24 months after procedure | Upper GI control gastroscopy. |
| Comorbidities improvement | 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. |
| Quality of life improvement | 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. * Score from -3.0 to -2.1: very poor quality of life * Score from -2.0 to -1.1: poor quality of life * Score from -1.0 to 1.0: fair quality of life * Score from 1.1 to 2.0: good quality of life * Score from 2.1 to 3.0: very good quality of life. |
Countries
France
Contacts
Primary ContactSilvana Perretta, MD, PhD
Backup ContactMichel Vix, MD
Outcome results
None listed