Roux-en-Y gastric bypass (raRYGB) with the MiniMIZER gastric ring (Bariatric Solutions International) resulted in enhanced weight loss over five years and reduced the incidence and severity of recurrent weight gain, according to researchers from the Netherlands. Despite the additional risk of ring-related complications, the investigators said this could be “a fair trade-off” when considering the number of patients who will not have secondary surgery for suboptimal clinical response. The findings were reported in the paper, ‘Ring Augmentation of the Roux‑en‑Y Gastric Bypass: A Propensity Score Matched Analysis of 5‑Year Follow‑Up Results’, published in Obesity Surgery.
The study authors sought to compare the five-year results of the RYGB with and without ring augmentation using a prefabricated gastric ring, applying propensity score matching to create balanced groups with population-based data. Only RYGB and raRYGB procedures with similar biliopancreatic (BPL) and alimentary limb (AL) lengths were included to ensure fair comparison and to estimate the isolated effect of adding a ring. They examined data were obtained from the Dutch Audit for Treatment of Obesity (DATO), which is a mandatory national quality registry for BMS.
A silicone ring specifically designed to be added to bariatric procedures, the MiniMIZER gastric ring, was used in all raRYGB cases. This flexible, but sturdy ring, is loosely placed around the newly created pouch so that it will not cause any restriction. Its placement is estimated to require approximately 3 to 5 minutes. Depending on the pouch size, the circumference of the ring can be adjusted from 6.5 to 8 cm. In the current study, the pouch was calibrated around a 40 Charrière gastric tube in all cases.
All raRYGB cases were performed with BPL lengths of 60cm and AL lengths of 120cm and only primary RYGB with BPL lengths of 50–70cm and AL lengths of 100–150cm were considered eligible for inclusion in the reference group.
The primary outcome was %TWL at five years after surgery, both on a continuous scale and dichotomised as achieving at least 25%TWL. Secondary outcomes included two weight-related adverse outcomes: excessive weight loss (i.e., dropping below a BMI of 20 kg/m2 at any time point) and recurrent weight gain (RWG) of>30% from the initial weight loss. Patients experiencing RWG at any time-point up to five years were considered to have experienced RWG, regardless of their actual weight loss status at five years.
Outcomes
In total, 507 patients underwent raRYGB during the specified period and 4,514 patients who received RYGB with similar intestinal limb lengths were identified. From these, 301 and 1,227 patients, had five-year follow-up data available. Matching resulted in 296 matched patients per treatment group with balanced baseline characteristics. The median BPL length in the RYGB group was 60cm and the median AL length was 150cm. In the raRYGB group, all patients had BPL lengths of 60cm and AL lengths of 120cm and the rings were closed at a circumference of 6.5–7.5 cm.
The mean %TWL at five years was 28.0% for RYGB and 31.5% for raRYGB (p<0.01), with patients receiving raRYGB having higher odds to achieve≥25% TWL (p<0.01). In addition, patients receiving raRYGB had lower odds to experience RWG (p=0.01). Excessive weight loss occurred in seven patients receiving raRYGB and four patients receiving RYGB which was not statistically different.
There were no significant differences in improvement of obesity complications at five years, except for raRYGB having lower odds to result in improvement of hypertension. Patients who underwent raRYGB had lower odds to experience prolonged length of stay (p<0.01). No statistically significant differences were found regarding postoperative complications and readmission rates.
There were 13 (4.4%) ring-related complications, all leading to reoperation. The median time between primary surgery and reoperation was 32 months (range 6–56). In seven (2.4%) patients, the ring was removed; in all others, the ring was replaced with a wider circumference, compared to the initial placement. Dysphagia was the most common complication among the ring-related complications (8/13). Of the patients with dysphagia, four had a ring size of 6.5 cm, three had 7 cm and one had 7.5 cm. After reoperation, the ring-related complaints were resolved in all patients. No erosions of the ring were seen in this study group.
raRYGB resulted in more %TWL at each point of follow-up, but these lines do not diverge over time. When focusing on the 20% of patients with the highest RWG in each treatment group, the amount of RWG was lower for patients receiving raRYGB.
The researchers said that future research should concentrate on which action mechanisms ring augmentation results in enhanced weight loss and less RWG, as well as exploring the combination of a longer BPL with raRYGB and the effect on obesity complication improvement. Importantly, they urged a focus on patient-reported outcomes to ensure that the ring has no negative impact on quality of life.
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