StomaphyX vs a sham procedure for revisional surgery to reduce regained weight in Roux-en-Y gastric bypass patients : a randomized clinical trial.

Importance: Revisional laparoscopic surgery after Roux-en-Y gastric bypass (RYGB) has been linked to substantial complications and morbidity.

Objective: To investigate the safety and effectiveness of endoscopic gastric plication with the StomaphyX device vs a sham procedure for revisional surgery in RYGB patients to reduce regained weight.

Design, Setting, And Participants: A prospective, single-center, randomized, single-blinded study from July 2009 through February 2011, evaluating revisional surgery using StomaphyX was conducted in patients with initial weight loss after RYGB performed at least 2 years earlier.