Natural orifice surgery: Initial US experience utilizing the StomaphyX ^TM device to reduce gastric pouches after Roux-en-Y gastric bypass

Introduction: Weight gain after gastric bypass can occur in up to 10% of patients 5 years following and in about 20% of patients 10 years following surgery. The nadir weight is usually reached within the first 2 years after bypass surgery. However, weight may slowly be regained for numerous reasons. This phenomenon has been studied extensively, but there is often no one reason this occurs. Once psychological and dietary reasons have been investigated, revisional surgery may be the only alternative for treatment. Revisional gastric bypass surgery is associated with a much higher morbidity and mortality when compared with a primary gastric bypass procedure. Patients and methods: Thirty-nine patients underwent endoluminal gastric pouch reduction with the StomaphyX^TM device after informed consent. The StomaphyX^TM device is a sterile, single-use device for use in endoluminal transoral tissue approximation and ligation in the gastrointestinal (GI) tract. Results: Average age was 47.8 (29-64) years, and 36/39 (92.3%) patients were female. Average body mass index (BMI) and weight prior to the StomaphyX^TM procedure were 39.8 (22.7-63.2) kg/m² and 108.0 kg (65.90-172.2 kg). The average preprocedure excess body weight was 51.1 kg. Weight loss at 2 weeks (n = 39) was 3.8 kg (7.4% excess body weight loss, EBWL), at 1 month (n = 34) was 5.4 kg (10.6% EBWL), at 2 months (n = 26) was 6.7 kg (13.1% EBWL), at 3 months (n = 15) was 6.7 kg (13.1% EBWL), at 6 months (n = 14) was 8.7 kg (17.0% EBWL), and at 1 year (n = 6) was 10.0 kg (19.5% EBWL). No major complications were observed. The minor complications that were seen included a sore throat lasting less than 48 h in 34/39 patients (87.1%) and epigastric pain that lasted for a few days in 30/39 patients (76.9%). Three patients with chronic diarrhea had their symptoms resolved after the procedure. Eight patients with gastroesophageal reflux disease reported improvement in their symptoms post procedure. Conclusions: Endoluminal revision of gastric bypass patients with weight gain using the StomaphyX^TM procedure may offer an alternative to open or laparoscopic revisional bariatric surgery.