Endoscopic conversion of sleeve gastrectomy to a new bypass method for reflux and obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the feasibility and effectiveness of an endoscopic procedure that converts sleeve gastrectomy to a single anastomosis sleeve-ileal bypass (SASI) using a lumen apposing metal stent (LAMS). It targets patients who have not achieved sufficient weight loss or have experienced weight regain after sleeve gastrectomy. The study proposes a less invasive, incisionless technique compared to traditional revisional laparoscopic surgeries, which carry higher risks of complications. By replicating the physiological effects of SASI, the study seeks to provide a safer alternative for patients struggling with metabolic syndrome and gastroesophageal reflux.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Subject must meet all the inclusion criteria to participate in this study and list each criterion.

1. Age: 21-65 years
2. Patients going for LSG at participating hospitals.
3. Able to provide informed consent

Individuals below age 21 would not be recruited as this is a study in the adult population. Individuals above age 65 are excluded to minimize the procedure risk.

Exclusion Criteria:

1. Patients who were breast feeding or pregnant
2. Severe psychiatric illness
3. Eating disorder
4. Active neoplastic disease
5. End-stage renal disease
6. Patients with bleeding diathesis
7. Patients with pacemakers or implantable cardiac defibrillators
8. Significant cardiovascular disease (e.g., acute myocardial infarction, congestive cardiac failure, ischemic heart disease, atrial fibrillation, sick sinus syndrome, supraventricular tachycardia)
9. Any factors likely to limit adherence to study protocol (e.g., dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other or family members)
10. Treatment with anti-platelet agents that could not be temporarily discontinued

Where it's running

• Changi General Hospital
  Singapore, Singapore Recruiting
• Sengkang General Hospital
  Singapore, Singapore Recruiting
• Singapore General Hospital
  Singapore, Singapore Recruiting

Study contacts

• Principal investigator: Chin Hong Lim, MD — Singapore General Hospital
• Study coordinator: Chin Hong Lim, MD
• Email: lim.chin.hong@singhealth.com.sg
• Phone: 62223322

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Impact of Sleeve Gastrectomy on Bone and Muscle Health in Men and Women

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• Asprosin and miRNA Profiles in Young Women with Metabolic Syndrome

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• 15-year outcomes after sleeve gastrectomy in France

  This study looks at how people who had sleeve gastrectomy have fared over 15 years to see long-term weight changes and health effects.

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• Mother and baby health after bariatric surgery in pregnancy

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  Recruiting at 3 sites Helse Nord-Trøndelag HF · Ålesund, Møre og Romsdal and 2 other locations · NCT07877233

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.