Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorSingapore Health Services

About this trial

The aim of this study is to determine the feasibility and effectiveness of endoscopic anastomosis of sleeve gastrectomy to ileum with a lumen apposing metal stent (LAMS) after a failed sleeve gastrectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 21-65 years

Patients going for LSG at participating hospitals.

Able to provide informed consent

Disqualifiers

Patients who were breast feeding or pregnant

Severe psychiatric illness

Eating disorder

Active neoplastic disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Endoscopic SASI

    Procedure/Surgery

    Endoscopic conversion to sleeve gastrectomy to SASI

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total amount of weight loss

Amount of weight loss after endoscopic conversion to SASI will be measured in kg and will be reported in percentage (%).

Time frame
6 months

Secondary outcomes

1

HbA1c

HbA1c levels will be measured and reported in percentage (%)

Time frame
6 months
2

GERD symptoms

Quality of Life in Reflux And Dyspepsia (QoLRAD) is a questionnaire used to assess how gastroesophageal reflux disease (GERD) and dyspepsia (indigestion) affects a person's quality of life. The total score will be calculated from the questionnaire and a reduction in QoLRAD score over time will demonstrate improvement.

Time frame
6 months

Other outcomes

1

Feasibility & Safety

Technical success rate \& procedure related complications. Number of adverse events will be recorded at all times to determine the feasibility and safety of the study procedure.

Time frame
30 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Singapore Health Services

Lead sponsor

Changi General Hospital

Collaborator

Sengkang General Hospital

Collaborator