Endoscopic Gastric Tubulization
ConditionMorbid Obesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorIHU Strasbourg
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients scheduled for an endoscopic gastric tubulization in the Nouvel Hôpital Civil, Strasbourg, France
Disqualifiers
None
Trial population
Patients over 18 years old requiring a treatment for morbid obesity.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Endoscopic gastric tubulization
Procedure/SurgeryEndoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA).
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Endoscopic gastric tubulization1 intervention
Trial outcomes
Primary outcomes
1
Change in weight loss
Change in weight loss measured in kilograms.
Time frame
7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure2
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
Time frame
7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure3
Change in body mass index variation
Change in body mass index variation measured in kg/m².
Time frame
7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedureSecondary outcomes
1
Number of patients with procedure-related adverse event
Number of patients with procedure-related adverse event within 12 months after procedure.
Time frame
7 days, 1 - 3 - 6 - 9 and 12 months after procedure2
Comorbidities improvement
Improvement of sleep apnea, arterial hypertension, diabetes, reflux, osteoarticular disorders compared with preoperative data.
Time frame
7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure3
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.
Time frame
3 - 12 - 18 and 24 months after procedure4
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.
Time frame
3 - 12 - 18 and 24 months after procedureSponsors and contacts
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Source ClinicalTrials.gov