Percutaneous Gastrostomy Device for the Treatment of Class II and Class III Obesity: Results of a Randomized Controlled Trial

The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy tube and an external device to facilitate drainage of about 30% of the calories consumed in a meal, in conjunction with lifestyle (diet and exercise) coun...

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Veröffentlicht in:The American journal of gastroenterology Jg. 112; H. 3; S. 447 - 457
Hauptverfasser: Thompson, Christopher C, Abu Dayyeh, Barham K, Kushner, Robert, Sullivan, Shelby, Schorr, Alan B, Amaro, Anastassia, Apovian, Caroline M, Fullum, Terrence, Zarrinpar, Amir, Jensen, Michael D, Stein, Adam C, Edmundowicz, Steven, Kahaleh, Michel, Ryou, Marvin, Bohning, Matthew J, Ginsberg, Gregory, Huang, Christopher, Tran, Daniel D, Glaser, Joseph P, Martin, John A, Jaffe, David L, Farraye, Francis A, Ho, Samuel B, Kumar, Nitin, Harakal, Donna, Young, Meredith, Thomas, Catherine E, Shukla, Alpana P, Ryan, Michele B, Haas, Miki, Goldsmith, Heidi, McCrea, Jennifer, Aronne, Louis J
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins 01.03.2017
Nature Publishing Group
Schlagworte:
Abdominal Pain - epidemiology
Adult
Diet Therapy
Drainage - methods
Endoscopy
Exercise Therapy
Female
Gastroenterology
Gastrostomy - methods
Granulation Tissue
Humans
Male
Middle Aged
Obesity - therapy
Postoperative Complications - epidemiology
Treatment Outcome
Weight Loss
ISSN:0002-9270, 1572-0241
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Zusammenfassung:The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy tube and an external device to facilitate drainage of about 30% of the calories consumed in a meal, in conjunction with lifestyle (diet and exercise) counseling. In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0-55.0 kg/m were randomly assigned in a 2:1 ratio to treatment with AspireAssist plus Lifestyle Counseling (n=137; mean BMI was 42.2±5.1 kg/m ) or Lifestyle Counseling alone (n=70; mean BMI was 40.9±3.9 kg/m ). The co-primary end points were mean percent excess weight loss and the proportion of participants who achieved at least a 25% excess weight loss. At 52 weeks, participants in the AspireAssist group, on a modified intent-to-treat basis, had lost a mean (±s.d.) of 31.5±26.7% of their excess body weight (12.1±9.6% total body weight), whereas those in the Lifestyle Counseling group had lost a mean of 9.8±15.5% of their excess body weight (3.5±6.0% total body weight) (P<0.001). A total of 58.6% of participants in the AspireAssist group and 15.3% of participants in the Lifestyle Counseling group lost at least 25% of their excess body weight (P<0.001). The most frequently reported adverse events were abdominal pain and discomfort in the perioperative period and peristomal granulation tissue and peristomal irritation in the postoperative period. Serious adverse events were reported in 3.6% of participants in the AspireAssist group. The AspireAssist System was associated with greater weight loss than Lifestyle Counseling alone.
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Present address: University of Colorado Denver, Denver, CO, USA
Present address: Mayo Clinic, Rochester, Minnesota, USA
ISSN:0002-9270
1572-0241
DOI:10.1038/ajg.2016.500