An interventional study of Endoscopic placement of additional sutures in Morbid Obesity, sponsored by IHU Strasbourg. Recruiting at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by IHU Strasbourg · Not applicable, Interventional, and Other
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.
Obesity is a health dilemma with an increased risk of premature death. Bariatric surgery is considered to be the most effective and durable treatment for morbid obesity as compared to other available options. However, only the most severe cases, namely class III or class II patients with obesity-related comorbidities fit the criteria for bariatric surgical interventions and are offered these options. Endoscopic sleeve gastroplasty (ESG) is a restrictive procedure based on the tubulization and shortening of the stomach, achieved by means of multiple full-thickness sutures applied endoscopically. ESG offers the possibility to obtain results (weight loss, improvement of comorbidities and quality of life) comparable to conventional surgery while reducing the risk of complications. One of the major advantages of this technique is that it does not make irreversible changes to gastric anatomy and function and can be repeated overtime if needed placing additional sutures. ESG appearance might be subject to changes overtime. In fact, depending on the sutures' integrity, the gastroplasty can be regarded as tight, partially open or completely open. Very little data currently exists in the literature on the effectiveness of endoscopic "revision" with the placement of additional sutures on weight loss and its impact on co-morbidities. In order to objectively assess the benefits and costs of a revision during the follow-up endoscopy patients who present a TWL \<10% or a BMI greater than 30 at 6 months from the primary ESG, will be randomized into 2 groups: a "Revision" group in which a revision will be performed systematically in the event of suture disruption at the control EGD, and a "Control" group which will only benefit of a control endoscopy regardless of the state of the gastroplasty.
Exclusion Criteria:
BMI≥30 or total weight loss (TBWL) \< 10% and relaxation of gastric tubulisation at 6 months after ESG. Additional stitches will be placed during the follow-up gastroscopy at 6 months.
Procedure: Endoscopic placement of additional sutures
The control gastroscopy will be performed without any additional procedure (no additional stitches).
A 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.
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 ESG
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 ESG
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 ESG
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 ESG
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 ESG
Comorbidity evolution
Assessment of comorbidities by comparing the evolution of comorbidities (hypertension, diabetes, sleep apnea syndrome, GERD with the questionnaire "GERD-Health Related Quality of Life Questionnaire GERD-HRQL", knee osteoarthritis) before and after the ESG. GERD-HRQL questionnaire contains 16 questions, ranged from 0 to 5. The higher the score is, the more important the gastroesophageal reflux is. The evolution of comorbidities 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 ESG
Gastric Emptying evaluation
Evaluation of gastric volume and emptying changes before and after ESG. The evaluation will be carried out performing a dynamic MRI before and 7 months after ESG. Dynamic MRI changes will be put in correlation with weight modifications (TWL, EWL and BMI).
Time frame: The data will be collected before and 7 months after the ESG
Gastric Emptying evaluation
Evaluation of gastric volume and emptying changes before and after ESG. The evaluation will be carried out performing a dynamic MRI before and 7 months after ESG. Dynamic MRI changes will be put in correlation with changes in secretion of intestinal hormones and glycemic profile (blood sugar, HbA1c, insulin, ghrelin, C-peptide, GLP-1 and Glucagon).
Time frame: The data will be collected before and 7 months after the ESG
Gastric Emptying evaluation
Evaluation of changes in gastric volume and gastric emptying comparing the results obtained by dynamic MRI between the two randomized groups ("Control" vs. "Revision"), with an additional correlation study of these results with weight loss: total weight lost (TWL%), excess weight loss (EWL%) and change in BMI. The data will be collected before ESG, and at 3, 6, 12, 18 and 24 months after ESG
Time frame: The data will be collected before and 7 months after the ESG
Gastric Emptying evaluation
Evaluation of changes in gastric volume and gastric emptying comparing the results obtained by dynamic MRI between the two randomized groups ("Control" vs. "Revision"), with an additional correlation study of these results with changes in secretion of intestinal hormones and glycemic profile (blood sugar, HbA1c, insulin, ghrelin, C-peptide, GLP-1 and Glucagon). The data will be collected before and 7 months after the ESG.
Time frame: The data will be collected before and 7 months after the ESG
Plan to share: No
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