Using gastric bypass stents to help patients regain weight after sleeve gastrectomy
The Application of Gastric Bypass Stents in Patients with Weight Regain After Laparoscopic Sleeve Gastrectomy：a Feasibility Study
This study is testing if using gastric bypass stents can help people who have gained weight back after having sleeve gastrectomy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06801496 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the feasibility of using gastric bypass stents in patients who have experienced weight regain after laparoscopic sleeve gastrectomy. It integrates various disciplines, including general surgery, endocrinology, nutrition, sports, and traditional Chinese medicine, to assess the effectiveness of this intervention. The study aims to improve patient outcomes and reduce the medical burden associated with obesity and its related conditions.
Who should consider this trial
Good fit: Ideal candidates include individuals with a BMI of 27.5 or higher who have not achieved weight control through lifestyle changes or medical treatment.
Not a fit: Patients with type 1 diabetes or those whose pancreatic beta-cell function is largely lost may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients struggling with weight regain after bariatric surgery.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1、For those with simple obesity, BMI ≥ 32.5, or 27.5 ≤ BMI \< 32.5, who have difficulty controlling their condition with lifestyle modifications and medical treatment, and who meet at least two criteria for metabolic syndrome components, or have comorbidities. 2、For those with simple obesity, 27.5 ≤ BMI \< 32.5, and with male waist circumference ≥ 90 cm, female waist circumference ≥ 85 cm, and imaging studies suggesting central obesity. 3、For those with type 2 diabetes, BMI ≥ 27.5, who still have some residual insulin secretion capacity. Exclusion Criteria: * 1、Non-obese type 1 diabetes; 2、Those for whom the purpose of treatment is T2DM, but whose pancreatic beta-cell function is largely lost, with a BMI \< 25.0; 3、Age \< 16 years or age \> 65 years; 4、Pregnant women with diabetes and patients with certain special types of diabetes; 5、Those with a cognitive disorder or immature intelligence, and who cannot control their behavior; 6、Those whose expectations for the surgery are not realistic; 7、Those unwilling to assume the risks of potential surgical complications; 8、Those unable to comply with postoperative dietary and lifestyle changes, showing poor compliance; 9、Those in poor general health, who are unable to tolerate general anesthesia or surgery.
Where this trial is running
Beijing
- China-Japan Friendship Hospital, Beijing, Beijing — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Hua Meng, Doctror
- Email: menghuade@hotmail.com
- Phone: 18611457779
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.