A procedure called transoral outlet reduction can reverse weight gain after Roux-en-Y gastric bypass (RYGB), according to a controlled clinical trial published in the July issue of Gastroenterology. Although these results were achieved using a superficial suction-based device, greater levels of weight loss could be achieved with newer, full-thickness suturing devices, say the authors of the study.
RYGB is one of the most effective weight loss procedures, increasing patients’ quality of life and reducing major cardiovascular and metabolic risk factors. Although it is not clear exactly how RYGB causes weight loss, its mechanism is likely to be multifactorial, involving restrictive and malabsorptive components.
Nonetheless, approximately 15%–20% of patients regain significant amounts of weight after gastric bypass. Weight regain involves many psychosocial, behavioral, and physiologic parameters, but loss of the restrictive aspect of the RYGB, via enlargement of the gastric pouch or gastrojejunal (GJ) stoma can also contribute. The diameter of the GJ stoma has associated with weight regain after RYGB surgery. During RYGB, the GJ stoma is generally constructed to be less than 15 mm in diameter—diameters of 2 cm or greater can prevent loss of weight or failure to maintain weight loss.
A dilated GJ stoma can be reduced by surgery, but the procedure is technically difficult, with considerable risk for complications. However, endoluminal suturing, first described for bariatric revision in 2004, avoids intra-abdominal dissection and its complications. Several suturing devices, tissue plication platforms, and tissue ablation techniques have shown various degrees of efficacy in managing weight regain after RYGB, but there is no well-defined evidence for the ability of endoluminal procedures to reduce weight regain after RYGB.
Christopher C. Thompson et al. evaluated the safety and efficacy of an endoluminal approach (transoral suturing using the Bard EndoCinch Suturing System, TORe) in 77 patients with weight regain or inadequate loss after RYGB and GJ stomal diameter greater than 2 cm. Fifty patients underwent TORe and 27 received a sham procedure (controls).
Six months later, subjects who received TORe had a greater mean percentage weight loss (3.9%) than controls (0.2%). Weight loss or stabilization was achieved in 96% subjects receiving TORe and 78% of controls. Mean body weight fell from 101.5±16.41 kg before TORe to 95.1±15.22 kg.
Both groups lost weight within the first 6 weeks after the study procedure. However, control patients had a trend toward weight regain between the 6-week and 6-month examinations. In contrast, the mean weight of the TORe group remained relatively stable between the 6-week and 6-month visit (see below figure).
Along with weight loss, the TORe group also had lower total cholesterol, triglyceride and insulin levels, and blood pressure than controls. Furthermore, 85% of the TORe group reported compliance with the healthy lifestyle eating program, compared with 53.8% of controls; 83% of TORe subjects said they would undergo the procedure again, and 78% said they would recommend the procedure to a friend. The groups had similar frequencies of adverse events.
The mean duration of the TORe procedure (from overtube placement to withdrawal) was 107±182.9 minutes. Technical success, defined as the ability to reduce the GJ stoma to 10 mm or less, was achieved for 89.6% of cases.
Thompson et al. conclude that the results from this trial provide Level I evidence for the safety and 6-month effectiveness of the TORe procedure for treatment of inadequate weight loss and/or weight regain after RYGB.
Longer-term follow-up evaluation is needed to determine the long-term effects. The authors state that the next generation of full-thickness suturing devices is likely to further improve outcomes. However, TORe is one approach to avoid weight regain—a longitudinal multidisciplinary approach with dietary counseling and behavioral changes are all required for adequate long-term results.
Read the article online.
Thompson CC, Chand B, Chen YK, et al. Endoscopic suturing for transoral outlet reduction increases weight loss after roux-en-y gastric bypass surgery. Gastroenterology 2013;145:129–137.e3.