ORLANDO, Fla. — Patients who regain weight after gastric bypass may benefit from transoral outlet reduction, according to data presented at Digestive Disease Week.
Researchers randomly assigned 25 patients who had experienced weight regain after Roux-en-Y gastric bypass (RYGB) to transoral outlet reduction (TORe) with a suction-based suture device (n=16) or a sham procedure (n=9). All participants had dilated gastrojejunal anastomosis (GJA; mean diameter, 27.3 mm in both groups) before the procedure.
“Weight regain after Roux-en-Y gastric bypass is common, occurring in 30% of patients within 2 years and almost two-thirds of patients within 4 years,” researcher Nitin Kumar, MD, gastroenterology fellow at Brigham & Women’s Hospital, said. “Weight regain after Roux-en-Y is correlated with dilated gastrojejunal anastomosis. … Trans-oral outlet reduction potentially offers a safe and effective modality for management of dilated GJA.”
The mean procedure time was 96.3 ± 9.3 minutes for TORe recipients, resulting in a mean GJA reduction to 3.6 ± 0.3 mm and a mean pouch reduction to 38.8 ± 2.5 mm in diameter. These participants experienced significantly more excess weight loss at 3 (20.7 ± 4.7% vs. –2.1 ± 3.4%; P=.02) and 6 months (23.1 ± 7% vs. –0.1 ± 3.3%; P=.03) than sham group patients. TORe group patients also experienced greater reduction in waist size (–8.1 ± 1.9 cm vs. –1.9 ± 1.1; P=.04 at 3 months and –6.5 ± 2.3 cm vs. 1.2 ± 0.9 cm; P=.03 at 6 months).
TORe recipients trended toward improved satiety, as indicated by change to a 10-point visual analog scale from pre-procedure values (2.3 ± 0.8 in the TORe group vs. –0.4 ± 1 in the sham group; P=.06). No incidence of adverse outcomes or device-related complications was observed. The number-needed-to-treat to achieve 15% excess weight loss was calculated as three patients.
“[TORe recipients] demonstrate significantly higher weight loss and more waist size reduction than patients undergoing a sham procedure,” Kumar said, noting a lack of long-term data on weight-loss results within the cohort. “This study provides evidence of the effectiveness of TORe in reversal of weight regain after Roux-en-Y gastric bypass.”
Disclosure: Researcher Christopher C. Thompson, MD, MHES, reported numerous financial disclosures.
For more information:
Kumar N. #306: Randomized Double-Blind Sham-Controlled Trial of Transoral Outlet Reduction for Weight Regain After Roux-en-Y Gastric Bypass: Single-Center Results. Presented at: Digestive Disease Week 2013; May 18-21, Orlando, Fla.