Purpose: To evaluate the effects of a new natural orifice surgical device to reduce gastric pouches after Roux-en-Y gastric bypass surgery.
Methods: The StomaphyX™ device is a sterile, single-use device that is Food and Drug Administration (FDA) cleared for use in endoluminal trans-oral tissue approximation and ligation in the gastrointestinal (GI) tract. We proposed that this device would be used to reduce the size of the gastric pouch to correct late weight gain following Roux-en-Y gastric bypass surgery.
Results: Twenty-four patients underwent the StomaphyX™ procedure. Mean age was 46, average pre-StomaphyX™ weight was 111.8 kg, and average Body Mass Index (BMI) was 41.9. Ninety-five percent of the patients were female with an average of 54.9% Excess Body Weight Loss (EBWL) after their initial bariatric operation. Two, four, eight, and twelve weeks follow-up were conducted. Average weight loss at 2 weeks was 2.8 kg (6.3 % EBWL), at 4 weeks was 4.8 kg. (10.6 % EBWL), at 8 weeks was 5.7 kg (11.5% EBWL) and at 12 weeks was 8.0 kg ( 18.1 % EBWL) . No major complications were observed. Two patients with chronic diarrhea for many years had their symptoms resolve after the procedure. Three patients with gastroesophageal reflux disease (GERD) were symptom free post-procedure and were taken off their Proton Pump Inhibitors (PPIs).
Conclusion: Endoluminal gastric pouch reduction is a safe and feasible procedure. Natural orifice surgery utilizing the StomaphyX™ procedure may offer an alternative to open or laparoscopic revisional bariatric surgery. The possibility of conducting long term randomized studies is being investigated.
Program Number: P031