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Post-RYGB weight regain

TORe reduces weight regain after RYGB

provides Level I evidence that TORe reduces weight regain after RYGB

Transoral outlet reduction (TORe) can reverse weight gain after Roux-en-Y gastric bypass (RYGB), according to the results of a controlled clinical trial published in Gastroenterology. The authors estimate that up to 20% of patients who have RYGB surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost, and they theorised that one possible explanation is that the opening between the stomach pouch and the intestine becomes stretched (thereby allowing food to pass from the stomach to the intestine too quickly causing patients to feel less full after eating).

As a result, the investigators evaluated the safety and efficacy of an endoluminal approach (transoral suturing using the Bard EndoCinch Suturing System, TORe), as an alternative to revision surgery.

They recruited 77 patients with weight regain or inadequate loss after RYGB and gastrojejunostomy stomal diameter greater than 2cm. Fifty patients underwent TORe and 27 received a sham procedure (controls). They assessed intraoperative performance, safety, weight loss, and clinical outcomes.

All participants had dilated gastrojejunal anastomosis (mean diameter, 27.3mm in both groups) before the procedure.

Results

The outcomes showed that patients who received TORe had a significantly greater mean percentage weight loss from baseline (3.5%; 95% confidence interval, 1.8%−5.3%) than controls (0.4%; 95% confidence interval, 2.3% weight gain to 3.0% weight loss) (p=0.021), using a last observation carried forward intent-to-treat analysis. Mean body weight fell from 101.5±16.41 before TORe to 95.1±15.22.

As-treated analysis also showed greater mean percentage weight loss in the TORe group than controls (3.9% and 0.2%, respectively; p=0.014). Weight loss or stabilization was achieved in 96% subjects receiving TORe and 78% of controls (p=0.019).

The TORe group also had reduced systolic and diastolic blood pressure (p<0.001) and a trend toward improved metabolic indices. In addition, 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 10mm or less, was achieved for 89.6% of cases.

“A multi-centre randomised trial provides Level I evidence that TORe reduces weight regain after RYGB,” concluded the authors. “These results were achieved using a superficial suction-based device; greater levels of weight loss could be achieved with newer, full-thickness suturing devices.”

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