by Matthew L. Brengman, MD, FASMBS, and Gregory L. Schroder, MD, FACS, FASMBS
Objective: To evaluate safety and outcomes at 12 months, including anchor durability, with use of an endolumenal tissue approximation system for repair of dilated gastro-jejunal stoma and gastric pouch tissue after Roux-en-Y gastric bypass surgery.
Conclusion: Incisionless revision of stoma and pouch dilatation with this flexible, incisionless operating platform was performed safely and without complication at 12 months. Weight loss in this patient subset was demonstrated. This endolumenal approach has potential to effectively address weight regain post-Roux-en-Y bypass in a safe, less invasive, and durable manner.
ClinicalTrials.gov Identifier: NCT01003743
Twenty to 30 percent of patients who undergo Roux-en-Y gastric bypass (RYGB) will experience significant weight regain.[1,2] The significantly increased morbidity and mortality with open or laparoscopic revision of the RYGB as compared to the primary procedure[3,4] often dissuades the clinician from performing, and the patient from seeking, surgical reintervention, despite of the documented benefits of this intervention on comorbidity and quality of life.[5,6] This is borne out by data that suggest that 3 to 10 percent of RYGB surgeries are revised yearly, despite the higher rate of weight regain post-bypass. Considering there have been over 100,000 bariatric surgeries performed yearly in the United States alone over the last decade[8,9] (most of which were RYGB surgeries), the number of patients needing revision is likely to rise significantly in the coming years.
Mechanical restriction of the stomach by decreasing gastric size/volume is an important component of the RYGB. Although weight regain post RYGB is multifactorial, most patients with weight regain post-RYGB do have evidence of outlet and/or pouch dilation as compared to their immediate post-RYGB result.
The ability to restore that restriction endoscopically through reducing the dilated pouch and gastric stoma is potentially a safer approach to addressing this common complication of RYGB surgery. A dilated pouch and/or stoma enlargement have been correlated with weight gain after primary RYGB surgery.[11,12]
Incisionless revision of stoma and pouch dilatation for weight regain following RYGB is achievable using IOP. We had good operative and postoperative safety. Mean weight loss at 12 months was significant with 100-percent adherence in this challenging patient subset. Anchor durability at 12 months was demonstrated. Based on our single site data, we feel this technological approach can offer patients another choice when considering their treatment options for weight regain post RYGB. We expect that with more experience with this platform, outcomes will improve. We hope larger studies will validate our one-year, single-site results.