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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. We planned for 120 patients to be randomized 2:1 to multiple full-thickness plications within the gastric pouch and stoma using the StomaphyX device with SerosFuse fasteners or a sham endoscopic procedure and followed up for 1 year. The primary efficacy end point was reduction in pre-RYGB excess weight by 15% or more excess body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) loss and BMI less than 35 at 12 months after the procedure. Adverse events were recorded.


RESULTS
Enrollment was closed prematurely because preliminary results indicated failure to achieve the primary efficacy end point in at least 50% of StomaphyX-treated patients. One-year follow-up was completed by 45 patients treated with StomaphyX and 29 patients in the sham treatment group. Primary efficacy outcome was achieved by 22.2% (10) with StomaphyX vs 3.4% (1) with the sham procedure (P < .01). Patients undergoing StomaphyX treatment experienced significantly greater reduction in weight and BMI at 3, 6, and 12 months (P ≤ .05). There was one causally related adverse event with StomaphyX, that required laparoscopic exploration and repair.


CONCLUSIONS AND RELEVANCE
StomaphyX treatment failed to achieve the primary efficacy target and resulted in early termination of the study.


TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT00939055.