Guidelines for healthy weight.
W C Willett, W H Dietz, G A Colditz
https://pubmed.ncbi.nlm.nih.gov/10432328/Actively Recruiting
Led by IHU Strasbourg · Updated on 2025-05-01
100
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying endoscopic sleeve gastroplasty ESG, a less invasive bariatric surgery technique for morbid obesity. This method involves reshaping the stomach with sutures to reduce size, offering weight loss results similar to conventional surgery but with fewer complications and reversible effects. The study aims to evaluate the benefits and costs of an endoscopic revision procedure, where additional sutures may be placed during follow-up if needed, as current data on this revision approach is limited. The study randomly assigns patients who show less than 10% total weight loss or a body mass index BMI over 30 six months after ESG into two groups. One group receives a revision with additional sutures placed during a follow-up gastroscopy, while the control group undergoes only the follow-up endoscopy without any new sutures. Both groups are monitored to assess the impact of this revision on weight loss and related health factors. Participants will have scheduled follow-up consultations and evaluations at 3, 6, 12, 18, and 24 months after the initial ESG procedure. These visits will collect data on total and excess weight loss, BMI, self-esteem, gastrointestinal quality of life, comorbidity changes, and gastric emptying before and seven months after ESG. The study includes safety monitoring and assessment of the revisions effects over two years.
CONDITIONS
Gastric Recalibration After Endoscopic Sleeve Gastroplasty
P
Pierre GOEPFERT
A
Armelle TAKEDA
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IHU Strasbourg
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants undergo Endoscopic Sleeve Gastroplasty (ESG). At 6 months after ESG, participants with a BMI≥30 or total weight loss less than 10% may receive an additional endoscopic placement of sutures if randomized to the revision group. Those in the control group will have follow-up endoscopy without additional sutures.
Follow-up endoscopy visit at 6 months
Duration - Up to 18 months after the 6-month treatment period (total up to 24 months after ESG)
Participants are followed to assess weight loss, BMI, self-esteem, quality of life, and comorbidities at multiple time points after ESG.
Follow-up consultations at 3, 6, 12, 18, and 24 months after ESG
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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