Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery

Christopher C. Thompson, Bipan Chand, Yang K. Chen, Daniel C. Demarco, Larry Miller, Michael Schweitzer, Richard I. Rothstein, David B. Lautz, James Slattery, Michele B. Ryan, Stacy Brethauer, Phillip Schauer, Mack C. Mitchell, Anthony Starpoli, Gregory B. Haber, Marc F. Catalano, Steven Edmundowicz, Annette M. Fagnant, Lee M. Kaplan, Mitchell S. Roslin

Research output: Contribution to journalArticle

62 Citations (Scopus)

Abstract

Background & Aims: Weight regain or insufficient loss after Roux-en-Y gastric bypass (RYGB) is common. This is partially attributable to dilatation of the gastrojejunostomy (GJ), which diminishes the restrictive capacity of RYGB. Endoluminal interventions for GJ reduction are being explored as alternatives to revision surgery. We performed a randomized, blinded, sham-controlled trial to evaluate weight loss after sutured transoral outlet reduction (TORe). Methods: Patients with weight regain or inadequate loss after RYGB and GJ diameter greater than 2 cm were assigned randomly to groups that underwent TORe (n = 50) or a sham procedure (controls, n = 27). Intraoperative performance, safety, weight loss, and clinical outcomes were assessed. Results: Subjects 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 =.021), using a last observation carried forward intent-to-treat analysis. As-treated analysis also showed greater mean percentage weight loss in the TORe group than controls (3.9% and 0.2%, respectively; P =.014). Weight loss or stabilization was achieved in 96% subjects receiving TORe and 78% of controls (P =.019). The TORe group had reduced systolic and diastolic blood pressure (P <.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. Conclusions: A multicenter randomized trial provides Level I evidence that TORe reduces weight regain after RYGB. These results were achieved using a superficial suction-based device; greater levels of weight loss could be achieved with newer, full-thickness suturing devices. TORe is one approach to avoid weight regain; a longitudinal multidisciplinary approach with dietary counseling and behavioral changes are required for long-term results. ClinicalTrials.gov identifier: NCT00394212.

Original languageEnglish (US)
JournalGastroenterology
Volume145
Issue number1
DOIs
StatePublished - Jul 2013

Fingerprint

Gastric Bypass
Weight Loss
Weights and Measures
Confidence Intervals
Blood Pressure
Equipment and Supplies
Suction
Reoperation
Multicenter Studies
Weight Gain
Counseling
Dilatation
Observation
Safety
Control Groups

Keywords

  • Dilated Anastomosis
  • Endocinch
  • Overstitch
  • Stomaphyx

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Thompson, C. C., Chand, B., Chen, Y. K., Demarco, D. C., Miller, L., Schweitzer, M., ... Roslin, M. S. (2013). Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. Gastroenterology, 145(1). https://doi.org/10.1053/j.gastro.2013.04.002

Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. / Thompson, Christopher C.; Chand, Bipan; Chen, Yang K.; Demarco, Daniel C.; Miller, Larry; Schweitzer, Michael; Rothstein, Richard I.; Lautz, David B.; Slattery, James; Ryan, Michele B.; Brethauer, Stacy; Schauer, Phillip; Mitchell, Mack C.; Starpoli, Anthony; Haber, Gregory B.; Catalano, Marc F.; Edmundowicz, Steven; Fagnant, Annette M.; Kaplan, Lee M.; Roslin, Mitchell S.

In: Gastroenterology, Vol. 145, No. 1, 07.2013.

Research output: Contribution to journalArticle

Thompson, CC, Chand, B, Chen, YK, Demarco, DC, Miller, L, Schweitzer, M, Rothstein, RI, Lautz, DB, Slattery, J, Ryan, MB, Brethauer, S, Schauer, P, Mitchell, MC, Starpoli, A, Haber, GB, Catalano, MF, Edmundowicz, S, Fagnant, AM, Kaplan, LM & Roslin, MS 2013, 'Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery', Gastroenterology, vol. 145, no. 1. https://doi.org/10.1053/j.gastro.2013.04.002
Thompson, Christopher C. ; Chand, Bipan ; Chen, Yang K. ; Demarco, Daniel C. ; Miller, Larry ; Schweitzer, Michael ; Rothstein, Richard I. ; Lautz, David B. ; Slattery, James ; Ryan, Michele B. ; Brethauer, Stacy ; Schauer, Phillip ; Mitchell, Mack C. ; Starpoli, Anthony ; Haber, Gregory B. ; Catalano, Marc F. ; Edmundowicz, Steven ; Fagnant, Annette M. ; Kaplan, Lee M. ; Roslin, Mitchell S. / Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. In: Gastroenterology. 2013 ; Vol. 145, No. 1.
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abstract = "Background & Aims: Weight regain or insufficient loss after Roux-en-Y gastric bypass (RYGB) is common. This is partially attributable to dilatation of the gastrojejunostomy (GJ), which diminishes the restrictive capacity of RYGB. Endoluminal interventions for GJ reduction are being explored as alternatives to revision surgery. We performed a randomized, blinded, sham-controlled trial to evaluate weight loss after sutured transoral outlet reduction (TORe). Methods: Patients with weight regain or inadequate loss after RYGB and GJ diameter greater than 2 cm were assigned randomly to groups that underwent TORe (n = 50) or a sham procedure (controls, n = 27). Intraoperative performance, safety, weight loss, and clinical outcomes were assessed. Results: Subjects 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 =.021), using a last observation carried forward intent-to-treat analysis. As-treated analysis also showed greater mean percentage weight loss in the TORe group than controls (3.9{\%} and 0.2{\%}, respectively; P =.014). Weight loss or stabilization was achieved in 96{\%} subjects receiving TORe and 78{\%} of controls (P =.019). The TORe group had reduced systolic and diastolic blood pressure (P <.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. Conclusions: A multicenter randomized trial provides Level I evidence that TORe reduces weight regain after RYGB. These results were achieved using a superficial suction-based device; greater levels of weight loss could be achieved with newer, full-thickness suturing devices. TORe is one approach to avoid weight regain; a longitudinal multidisciplinary approach with dietary counseling and behavioral changes are required for long-term results. ClinicalTrials.gov identifier: NCT00394212.",
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T1 - Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery

AU - Thompson, Christopher C.

AU - Chand, Bipan

AU - Chen, Yang K.

AU - Demarco, Daniel C.

AU - Miller, Larry

AU - Schweitzer, Michael

AU - Rothstein, Richard I.

AU - Lautz, David B.

AU - Slattery, James

AU - Ryan, Michele B.

AU - Brethauer, Stacy

AU - Schauer, Phillip

AU - Mitchell, Mack C.

AU - Starpoli, Anthony

AU - Haber, Gregory B.

AU - Catalano, Marc F.

AU - Edmundowicz, Steven

AU - Fagnant, Annette M.

AU - Kaplan, Lee M.

AU - Roslin, Mitchell S.

PY - 2013/7

Y1 - 2013/7

N2 - Background & Aims: Weight regain or insufficient loss after Roux-en-Y gastric bypass (RYGB) is common. This is partially attributable to dilatation of the gastrojejunostomy (GJ), which diminishes the restrictive capacity of RYGB. Endoluminal interventions for GJ reduction are being explored as alternatives to revision surgery. We performed a randomized, blinded, sham-controlled trial to evaluate weight loss after sutured transoral outlet reduction (TORe). Methods: Patients with weight regain or inadequate loss after RYGB and GJ diameter greater than 2 cm were assigned randomly to groups that underwent TORe (n = 50) or a sham procedure (controls, n = 27). Intraoperative performance, safety, weight loss, and clinical outcomes were assessed. Results: Subjects 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 =.021), using a last observation carried forward intent-to-treat analysis. As-treated analysis also showed greater mean percentage weight loss in the TORe group than controls (3.9% and 0.2%, respectively; P =.014). Weight loss or stabilization was achieved in 96% subjects receiving TORe and 78% of controls (P =.019). The TORe group had reduced systolic and diastolic blood pressure (P <.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. Conclusions: A multicenter randomized trial provides Level I evidence that TORe reduces weight regain after RYGB. These results were achieved using a superficial suction-based device; greater levels of weight loss could be achieved with newer, full-thickness suturing devices. TORe is one approach to avoid weight regain; a longitudinal multidisciplinary approach with dietary counseling and behavioral changes are required for long-term results. ClinicalTrials.gov identifier: NCT00394212.

AB - Background & Aims: Weight regain or insufficient loss after Roux-en-Y gastric bypass (RYGB) is common. This is partially attributable to dilatation of the gastrojejunostomy (GJ), which diminishes the restrictive capacity of RYGB. Endoluminal interventions for GJ reduction are being explored as alternatives to revision surgery. We performed a randomized, blinded, sham-controlled trial to evaluate weight loss after sutured transoral outlet reduction (TORe). Methods: Patients with weight regain or inadequate loss after RYGB and GJ diameter greater than 2 cm were assigned randomly to groups that underwent TORe (n = 50) or a sham procedure (controls, n = 27). Intraoperative performance, safety, weight loss, and clinical outcomes were assessed. Results: Subjects 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 =.021), using a last observation carried forward intent-to-treat analysis. As-treated analysis also showed greater mean percentage weight loss in the TORe group than controls (3.9% and 0.2%, respectively; P =.014). Weight loss or stabilization was achieved in 96% subjects receiving TORe and 78% of controls (P =.019). The TORe group had reduced systolic and diastolic blood pressure (P <.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. Conclusions: A multicenter randomized trial provides Level I evidence that TORe reduces weight regain after RYGB. These results were achieved using a superficial suction-based device; greater levels of weight loss could be achieved with newer, full-thickness suturing devices. TORe is one approach to avoid weight regain; a longitudinal multidisciplinary approach with dietary counseling and behavioral changes are required for long-term results. ClinicalTrials.gov identifier: NCT00394212.

KW - Dilated Anastomosis

KW - Endocinch

KW - Overstitch

KW - Stomaphyx

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