MiniMizer Ring and pouch resizing effective for symptom control in patients with dumping syndrome and post-bariatric surgery hypoglycemia
- owenhaskins
- 9 hours ago
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Implanting a silicone ring (MiniMizer Ring, Bariatric Solutions) and pouch resizing offer an effective therapeutic strategy for symptom control in patients with dumping syndrome (DS) and post-bariatric surgery hypoglycemia (PBH) independent of effects on glycaemic dynamics, according to the results of a prospective single-arm trial by researchers from the University of Freiburg, Freiburg, Germany. However, they cautioned that complete resolution of dumping symptoms is only possible for a minority of patients.
The researchers noted that DS and PBH occur in up to 40% after bariatric surgery. The former is triggered by osmotic pressure of nutrients and subsequent diffusion of fluid into the bowel lumen, while the latter is caused by consumed carbohydrates resulting in exaggerated insulin/GLP-1 release and subsequent hypoglycemia. In most patients, symptoms can be controlled by consumption of small meals with a low carbohydrate content. However, some 2.5% of patients develop substantially impaired quality of life. Therefore, unless bypass anatomy as precondition for both conditions is reversed, efficient treatment for these patients is challenging.
A previous study reported that endoscopic pouch outlet reduction led to resolution of DS in 57% of patients two years following the procedure1, whilst a retrospective single-centre series primarily analysing revisionary surgery for weight regain after Roux-en-Y gastric bypass (RYGB) demonstrated a relief of dumping symptoms in 58% following the implantation of a silicone ring implantation2.
Therefore, the researchers designed a single-centre, open-label, single-arm trial including patients suffering from DS or PBH following RYGB to assess whether silicone ring implantation (MiniMizer Ring) and pouch resizing can lead to improvements in the clinical symptoms of DS/PBH. Clinical outcome measurements included Sigstad score and Arts dumping severity scale determined at inclusion, three and 12 months post-operatively.
In total, 16 patients were included in the study who had undergone a failed conservative approach for dumping treatment and were indicated for pouch resizing, plus silicone ring placement. Among the 16 patients recruited, RYGB was the primary bariatric operation in 15 patients (one patient had been previously converted from a sleeve gastrectomy to a RYGB due to severe reflux). Patients received a complete adhesiolysis of the pouch and gastrojejunostomy (GJ). Pouch dilatation was assessed by air insufflation. Silicone ring implantation was conducted at 56 (42.4–69.7) months after RYGB. Gastric pouch was resized in 15 patients (one patient with a narrow pouch did not require resizing).
Outcomes
The researchers reported that Sigstad score decreased from 20.4 (17.8–23.1) to 10.4 (6.7–14.1; p=0.0002). The median calculated score difference was −12 (−16 to −2). Sigstad score diminished by 50% in 88% of patients three months after revision and in 56% after 12 months. Only four patients presented with formally non-pathological Sigstad score values (score < 7). Hiatoplasty or candy cane resection had no influence on Sigstad score improvement.
They also found that Arts dumping severity scale globally decreased by a median of 11.5 (−13 to −7; p=0.0001) points. Score value dropped from 20.3 (16.7–23.9) to 10 (6.5–13.5). Interestingly, they noted that intervention was equally effective reducing score values for DS (12.9 (10.8–15.0) to 6.3 (3.9–8.7); p=0.0001) and PBH (7.4 (CI 4.9–10) to 3.7 (1.7–5.6); p=0.0018).
Nadir total weight loss (TWL) after RYGB was 36%. Prior to silicone ring implantation, TWL had decreased to 21.5%. Eight patients regained >20% of body weight, four patients >30% and excess weight loss was 50% in eight patients. Twelve months following the study intervention, mean weight loss was 5.1% (p=0.03) or 5.2 kg (p=0.02). Six patients did not experience any weight loss; five patients lost > 10%. Weight loss after silicone ring implantation correlated with weight regained from nadir weight (Pearson r 0.55).
Surgical complications Clavien-Dindo Class I occurred in two patients - one patient experienced a postoperative staple line bleeding which required operative revision (Clavien-Dindo IIIb) and reflux esophagitis (grade A) was detected in one patient before revision and persisted in the control gastroscopy. There were no instances of ring migration or displacement, regurgitation was present in five (31.3%) patients pre-operatively and after silicone ring implantation (three patients with persisting regurgitation and two patients with newly diagnosed symptoms).
“This is the first prospective trial analysing symptoms of DS and PBH following silicone ring augmentation. This intervention led to a sustained Sigstad score improvement by 50% or more at 12 months in 56% of patients. The improvement in Arts dumping score suggested a similar effect on symptoms of DS and PBH. Full dumping symptom resolution was achieved in 25% of patients,” the authors stated. “In contrast, one-year retrospective data on silicone ring implantation without pouch resizing in 24 patients demonstrated a resolution of 58%. However, dumping symptoms were measured only semi-quantitatively in this trial. For TORe, resolution of dumping was described in 67% at one year in a set of patients with a considerably lower initial Sigstad score.”
The findings were reported in the paper, 'Ring Augmentation and Pouch Resizing for the Treatment of Dumping Syndrome After Roux‑en‑Y Gastric Bypass: A Prospective Single‑Center Trial', published in Obesity Surgery. To access this paper, please click here
References
Pontecorvi V, Matteo MV, Bove V, et al. Long-term outcomes of transoral outlet reduction (TORe) for dumping syndrome and weight regain after Roux-en-Y gastric bypass. Obes Surg. 2023;33(4):1032–9. https://doi.org/10.1007/s11695-023-06466-w
Linke K, Schneider R, Gebhart M, et al. Outcome of revisional bariatric surgery for insufficient weight loss after laparoscopic Roux-en-Y gastric bypass: an observational study. Surg Obes Relat Dis. 2020;16(8):1052–9. https://doi.org/10.1016/j.soard.2020.04.009