Clinical trial NCT03554902: Endoscopic Gastric Tubulization
Official title: Endoscopic Gastric Tubulization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Morbid Obesity
Keywords: Endoscopic gastric tubulization
Weight loss
Quality of life
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years old requiring a treatment for morbid obesity.

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.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for an endoscopic gastric tubulization in the Nouvel Hôpital Civil, Strasbourg, France

Primary outcomes:
measure: Change in weight loss
timeFrame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
measure: Change in excess weight loss
timeFrame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
measure: Change in body mass index variation
timeFrame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Secondary outcomes:
measure: Number of patients with procedure-related adverse event
timeFrame: 7 days, 1 - 3 - 6 - 9 and 12 months after procedure
measure: Comorbidities improvement
timeFrame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
measure: Quality of life improvement
timeFrame: 3 - 12 - 18 and 24 months after procedure
measure: Gastro-intestinal quality of life improvement
timeFrame: 3 - 12 - 18 and 24 months after procedure
measure: Modification in the feeling of satiety
timeFrame: 1 - 3 - 6 - 12 - 18 and 24 months after procedure
measure: Upper GI tract radiologic evaluation
timeFrame: 1 day, 6 - 12 and 24 months after procedure
measure: Upper GI tract endoscopic evaluation
timeFrame: 6 - 12 and 24 months after procedure
measure: Procedure duration
timeFrame: At time of procedure
measure: Number of stitches in place
timeFrame: At time of procedure
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Study officials:
affiliation: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
name: Silvana Perretta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
name: Michel Vix, MD
role: PRINCIPAL_INVESTIGATOR
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