24
Participants
Start Date
September 24, 2023
Primary Completion Date
July 1, 2027
Study Completion Date
July 1, 2027
Endoscopic Sleeve Gastroplasty (ESG)
ESG will be performed under general anaesthesia with orotracheal intubation. The Endomina® suturing system (EndoTools Therapeutics S.A., Gosselies, Belgium) mounted on a single channel endoscope (GIF-H190/GIF-HQ190; Olympus Medical Systems Corp., Tokyo, Japan) will be used. This system allows to obtain full thickness gastric sutures through the gastric wall of the gastric body, leaving the antrum and the gastric fundus free. The ESG starts with the reduction of the gastric body, suturing from distal to proximal and starting from the notch of the angulus and ending at the level of the fundus. 4-8 full thickness stitches will be placed, with 2 passes per stitch. The final effect of ESG is the creation of a gastric tubule thus reducing the volume of the stomach. After the procedure, the final shape will be evaluated, to examine any gaps that would require additional closure, and to exclude bleedings and/or other complications.
RECRUITING
Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER