Endomina Post RYGB
Endomina Post RYGB
Surgery is the only effective treatment for morbid obesity and can be divided into
 restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary
 pancreatic deviation and duodenal switch) or a combination of both (RYGBP).

 This later technique is the most common and most effective surgical procedure performed
 worldwide and has been processed to be an effective treatment of morbid obesity and its
 complications, achieving excess weight loss of 65 to 80 % ; 1-2 years after surgery.1
 However, after the initial weight loss induced by RYGBP; 50 % of patients regain some weight
 2 and approximately 20 % of the patients will reach again a BMI of 35 at 10 years , defined
 as a failure rate.3 The reasons for weight regain are multiple but the most two potential
 contributing factors are related with the loss of the restrictive effect of the RYGBP by
 stretching of the gastric pouch and/or the gastrojejunal anastomosis (GJA), leading to
 increased satiety.

 Surgical options available for treating weight regain after RYGBP include placement of
 adjustable gastric band, Redo of the anastomosis or Reconstruction of the pouch.4 These
 procedures are technically difficult especially in patients who had previous single or
 multiple surgical interventions leading to a morbidity of around 15 % and a mortality of 1 %;
 Which is twice the one of the original surgery. This justifies the interest in less invasive,
 peroral revisions that include injection of sclerosant or suturing the anastomosis using
 Endoluminal gastroplication device (EndoCinch; Bard) 5,6 They have been however of marginal
 effectiveness compared to the medical treatment may be because their effect is limited to the
 anastomosis and doesn't reduce the size of the stretched gastric pouch. StomaphyX
 (Endogastric Solutions, Redmond, WA) is another systems aiming to reduce the gastric pouch
 has proved initial efficacy but are disappointing on the long term by a lack of persistence
 of the plicators. 7, 8 Endomina (Endo Tools Therapeutics, Nivelles, Belgium) is CE mark robot
 driven device that may be attached to an endoscope inside the body and allows remote
 manipulation of the arms of devices during a peroral intervention. It offers the
 possibilities of making transoral surgical full thickness sutures and may allow performing,
 via a transoral route, an intervention combining anastomoses reduction and gastric pouch
 reduction. It might be an effective treatment option for patients regaining weight after
 RYGBP and having a stretched pouch and or anastomosis.
Inclusion Criteria:

 1. Age between 21-64 years;

 2. BMI > 30 Kg/m2

 3. Previous gastric bypass with limited results

 4. Must be able to comply with all study requirements for the duration of the study as
 outlined in the protocol. This includes complying with the visit schedule as well as
 study specific procedures such as: clinical assessment , endoscopy, radiography, as
 well as laboratory investigations.

 5. Must be able to understand and be willing to provide written informed consent.

 Exclusion Criteria:

 1. Achalasia and any other esophageal motility disorders

 2. Heart diseases: unstable angina, myocardial infarction within the past year, or heart
 disease classified within the New York Heart Association's Class III or IV functional
 capacity.

 3. Hypertension: uncontrolled hypertension during last 3 month

 4. Severe renal, hepatic, pulmonary disease or cancer;

 5. GIT stenosis or obstruction

 6. Pregnancy or breastfeeding

 7. Impending gastric surgery 60 days post intervention;

 8. Currently participating in other study