Obesity Clinical Trial
Official title:
A Prospective Study to Evaluate the Safety and Feasibility of an Endoluminal Suturing Device (Endominav2Mini) as an Aid for Pouch Reduction After Roux-And-Y-Gastric-Bypass Surgery
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.
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