Endoscopic Management of Weight Regain post Gastric Bypass

Not Applicable

• Conditions: Bariatric; Weight regain post gastric bypass; Obesity; Diet and Nutrition - Obesity

• Registration Number: ACTRN12619000624189
• Lead Sponsor: Department of Gastroenterology and Hepatology, The Royal Brisbane and Women's Hospital, Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-26
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•Minimal post-operative period of 18 months;
•Regain of at least 10% of lowest weight attained post RYGB
•Anastomotic diameter of at least 12mm
•Able to provide consent for the procedure

Exclusion Criteria

•Inability to give informed consent
•Women who are pregnant or intending to become pregnant in the 12 months after procedure
•Advanced medical comorbidities defined as
oDecompensated cirrhosis
oCardiac failure with NYHA class III and IV symptoms
oCOPD – Stage III and IV
oKidney dysfunction on dialysis
oActive cancer undergoing treatment
oCerebrovascular accident causing significant functional impairment
oSevere nutritional deficiencies
oalcoholism
odrug addiction
orecent neoplasia (less than 5 years)
oHIV seropositivity
•Anti-coagulant or anti-platelet agent, with the exception of Aspirin
•Allergy to medications used for anaesthetics

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight change before and after the endoscopic revision. Digital scales will be used.[Baseline and at 3-, 6-, 9-, 12-, 18-, and 24- months after procedure]

Secondary Outcome Measures

Name	Time	Method
ot applicable[Not applicable]