Researchers from Obesity Center Máxima, Máxima Medical Center, Department of Surgery, Eindhoven/Veldhoven, in the Netherlands, have initiated the ‘Banded Roux-en-Y gastric bypass in patients with superobesity (BRandY-study)’ to assess the added value of the banded Roux-en-Y gastric bypass in patients with super-obesity (BMI>50) on long-term weight loss outcomes. The outline paper describing the study, ‘Banded Roux-en-Y gastric bypass in patients with super morbid obesity (BRandY-study): protocol of a cohort study with 10 year follow-up’, was published in BMC Surgery.
This single centre study is evaluating 142 patients with superobesity who receive a non-banded Roux-en-Y gastric bypass (NB-RYGB) and a banded Roux-en-Y gastric bypass (B-RYGB). Data from the NB-RYGB group will be collected in retrospect, consisting of patients that were operated between January 2017 and November 2019. At December 2019, the B-RYGB was introduced in at the study centre as standard of care. From that point on, data is collected prospectively.
When performing a B-RYGB, a 7.0–8.0 cm silastic ring (MiniMizer, Bariatric Solutions International) will be placed proximal to the gastrojejunostomy. It is hypothesized that the MiniMizer hampers a large food bolus to enlarge the pouch and stoma in time, thereby preventing secondary non-response. Furthermore, it may delay food passage through the pouch resulting in decreased food intake, thereby preventing primary and secondary non-response.
Laparoscopic placement of the MiniMizer Ring involves a small perigastric tunnel made in which the silastic ring is entered. The ring is placed around the pouch 2cm proximally to the gastrojejunostomy. The ring is closed at either 7.0, 7.5 or 8.0cm depending on the size of the gastric pouch. By inserting a gastric tube of 34-French before locking the ring, it is tested whether the ring is not too tight.
After locking, the tip of the ring is cut and removed. The ring is fixed by two non-absorbable stitches placed at the gastric wall. Petersen space is routinely closed, while the mesodefect of the enteroenterostomy is only closed on indication. For closure of defects, a non-absorbable suture is placed in a running fashion. In case of a hiatal hernia, a laparoscopic crural repair is performed with sutures and/or mesh placement. This repair is performed during the same procedure as the gastric bypass. If the hernia is too large and therefore inoperable, the patient does not receive a MiniMizer.
The main outcomes of this study are weight loss and non-response during a ten-year follow-up period. Secondary outcomes are reduction of obesity related comorbidities and medication, (ring-related) morbidity and mortality, complications, re-operations, patient satisfaction and health-related quality of life. The researchers believe the study will help establish the clinical utility of the B-RYGB in superobese patients.
Data will be collected by from baseline (pre-operatively) and at 30 days, on year, 18 months and each year thereafter out to ten years after surgery, and includes patient demographics, comorbidities and medication use, operating time, length of hospital stay, (ring-related) morbidity and mortality, complication and re-operations. Comorbidities that are taken into account are hypertension, dyslipidaemia, type 2 diabetes, sleep apnoea syndrome, osteoarthritis and gastroesophageal reflux.
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