Endoscopic Gastric Tubulization

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endoscopic Gastric Tubulization

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Endoscopic gastric tubulization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for an endoscopic gastric tubulization in the Nouvel Hôpital Civil, Strasbourg, France

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoscopic gastric tubulization<br>Endoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). | Procedure: Endoscopic gastric tubulization<br>* Endoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight loss | Change in weight loss measured in kilograms. | 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure | 
| Change in excess weight loss | 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 | 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure | 
| Change in body mass index variation | Change in body mass index variation measured in kg/m². | 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with procedure-related adverse event | Number of patients with procedure-related adverse event within 12 months after procedure. | 7 days, 1 - 3 - 6 - 9 and 12 months after procedure | 
| Comorbidities improvement | Improvement of sleep apnea, arterial hypertension, diabetes, reflux, osteoarticular disorders compared with preoperative data. | 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure | 
| Quality of life improvement | 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. | 3 - 12 - 18 and 24 months after procedure | 
| Gastro-intestinal quality of life improvement | Improvement of quality of life assessed by the Gastro-Intestinal Quality of Life Index questionnaire. A global score > 125 is considered as normal. | 3 - 12 - 18 and 24 months after procedure | 
| Modification in the feeling of satiety | 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. | 1 - 3 - 6 - 12 - 18 and 24 months after procedure | 
| Upper GI tract radiologic evaluation | Upper GI control series. | 1 day, 6 - 12 and 24 months after procedure | 
| Upper GI tract endoscopic evaluation | Upper GI control gastroscopy. | 6 - 12 and 24 months after procedure | 
| Procedure duration | Time required to perform the endoscopic gastric tubulization. | At time of procedure | 
| Number of stitches in place | Number of stitches put in place during the endoscopic gastric tubulization. | At time of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic gastric tubulization, Weight loss, Quality of life