Abstract
BACKGROUND: Early dumping syndrome (DS) and postbariatric surgery hypoglycemia (PBH) are common side effects after Roux-en-Y gastric bypass (RYGB) and may substantially impact patients' quality of life. Established management options provide limited response in many patients. This trial tested the effect of pouch resizing and silicone ring implantation (trial intervention) in patients with dumping symptoms after RYGB. METHODS: The trial intervention was assessed in a prospective single-arm trial including 16 patients. The primary endpoint was the change in Sigstad score 12 months after surgery. Secondary endpoints included Arts dumping score, insulin secretion, and glucose uptake assessed by a mixed meal tolerance test (MMTT), weight loss, quality of life, and safety evaluated by gastroscopy and contrast swallow. RESULTS: The trial intervention led to a significant improvement in Sigstad (preOP: 20.4 (95% CI 17.8-23.1); 12 months: 10.4 (6.7-14.1); P = 0.0002) and Arts dumping score (preOP: 20.3 (16.7-23.9); 12 months: 10 (6.5-13.5); P = 0.0001). Glucose uptake and insulin secretion during MMTT remained largely unchanged (AUC glucose: 21,526 (19,654-23,398) mg/dl*min vs. 12 months 22,294 (20,511-24077) mg/dl*min), P = 0.21; AUC insulin: (preOP 62897 (33,531-92,263) pmol/l*min vs. 12 months 68,974 (40,691-97257) pmol/l*min, P = 0.19). Following the trial intervention, mean weight loss was 5.1% (1.4-8.9%). No ring migration or misplacement occurred during follow-up. CONCLUSIONS: Pouch resizing and silicone ring implantation led to a clinically relevant improvement in symptoms associated with DS and PBH. This was not related to an apparent impact on glycemic regulation.