Gastric Recalibration After Endoscopic Sleeve Gastroplasty
ConditionMorbid Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorIHU Strasbourg
About this trial
Endoscopic sleeve gastroplasty (ESG) is a technique used for bariatric surgery, with results comparable to conventional surgery, in order to treat morbid obesity. It has also less risks of complications, and it is not an irreversible technique. It can be repeated overtime, regarding the evolution of the gastroplasty. There is little data in the literature on the effectiveness of endoscopic "revision". This study will assess the benefits and costs of a revision during the follow-up endoscopy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 to 75
Patients with morbid obesity (BMI≥ 30 with comorbidities or> 40)
Patients with obesity for more than 2 years
Failure of medical treatment of obesity
Disqualifiers
Patient with a contraindication to perform an ESG
Patient with a history of previous bariatric, gastric or esophageal surgery.
Patient who initiated medical therapy within the last 3 months, with evidence of weight gain.
Patient with an uncontrolled, poorly controlled, or suspected history of eating disorders or psychiatric illness.
Trial design
Design model
Parallel
Treatments tested in this trial
Endoscopic placement of additional sutures
Procedure/SurgeryA new endoscopic suture will be performed in case of a BMI≥30 or total weight loss (TBWL) less than 10%, and relaxation of gastric tubulization during the regular endoscopic follow-up after 6 months from the ESG. The same endoscopic suture technique of the primary ESG will be applied.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: RevisionExperimental treatment 1 intervention
Group B: Without revisionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Total weight loss (TWL)
The primary endpoint is the assessment of weight evolution in terms of total weight loss (TWL) between the two randomized groups ("Control" vs. "Review"). The evolution of the TWL will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.
Time frame
3, 6, 12, 18 and 24 months after the ESGSecondary outcomes
1
Excess weight loss (EWL)
Evaluation of weight loss in terms of excess body weight evolution (EWL) between the two randomized groups ("Control" vs. "Review"). The evolution of the EWL will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.
Time frame
The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG2
Body mass index (BMI)
Evaluation of the weight loss in terms of body mass index (BMI) between the two randomized groups. The evolution of the BMI will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.
Time frame
The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG3
Self-esteem and activities evaluation
Assessment of the self-esteem and activities before and after the ESG, using the 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. The evolution of will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.
Time frame
The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG4
Gastrointestinal quality of life evaluation
Assessment of the gastrointestinal quality of life before and after the ESG, using GIQLI (GastroIntestinal Quality of Life Index) questionnaire. There are 36 questions, each ranged from 0 to 4. A global score \>125 is considered as normal. The evolution of the gastrointestinal quality of life will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.
Time frame
The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESGSponsors and contacts
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Source ClinicalTrials.gov