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

ABSTRACT: OBJECTIVES: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. METHODS:In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0-55.0?kg/m2 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/m2) or Lifestyle Counseling alone (n=70; mean BMI was 40.9±3.9?kg/m2). 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. RESULTS: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. CONCLUSIONS:The AspireAssist System was associated with greater weight loss than Lifestyle Counseling alone.

SUBMITTER: Thompson CC

PROVIDER: S-EPMC5350543 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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

Thompson Christopher C CC Abu Dayyeh Barham K BK Kushner Robert R Sullivan Shelby S Schorr Alan B AB Amaro Anastassia A Apovian Caroline M CM Fullum Terrence T Zarrinpar Amir A Jensen Michael D MD Stein Adam C AC Edmundowicz Steven S Kahaleh Michel M Ryou Marvin M Bohning J Matthew JM Ginsberg Gregory G Huang Christopher C Tran Daniel D DD Glaser Joseph P JP Martin John A JA Jaffe David L DL Farraye Francis A FA Ho Samuel B SB Kumar Nitin N Harakal Donna D Young Meredith M Thomas Catherine E CE Shukla Alpana P AP Ryan Michele B MB Haas Miki M Goldsmith Heidi H McCrea Jennifer J Aronne Louis J LJ

The American journal of gastroenterology 20161206 3

<h4>Objectives</h4>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.<h4>Methods</h4>In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0-55.0 kg/m<sup>2</sup> were randomly assigned in a 2:1 ratio to treatment ...[more]

PMID: 27922026

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Project description:BackgroundPeriodontal accelerated osteogenic orthodontics (PAOO) is a widely-used clinical procedure that combines selective alveolar corticotomy, particulate bone grafting, and the application of orthodontic forces. Different modifications of PAOO such as collagen-membrane coverage can better benefit patients from preventing displacement of grafts. Due to its stability, collagen-membrane coverage gradually gained popularity and became a widely-used procedure in traditional PAOO technique.ObjectivesTo quantitatively investigate the radiographic changes of alveolar bone, periodontal soft tissue changes of the mandibular anterior teeth and postoperative complications in periosteum-covered techniques compared with traditional surgical technique in PAOO.MethodsOrthodontic camouflage for dental Class II or decompensation for skeletal Class III malocclusions were included; Patients with bone defects on the buccal aspects of the anterior mandible regions confirmed by clinical and radiographic examination were randomly divided into the periosteum coverage group or traditional technique group for PAOO. Cone-beam computerized tomography (CBCT) scans were obtained before treatment (T0) and 1 week (T1) and 12 months (T2) after operation. The primary outcome variable was the vertical alveolar bone level (VBL), the secondary evaluation parameters included labial horizontal bone thickness at the midpoint of the middle third (MHBT) or apical third (AHBT) to the limit of the labial cortical surface during a 12-month follow-up. Postoperative sequelae were evaluated after 2 days and 7 days in both the groups. Periodontal parameters were analyzed at T0 and T2.ResultsThirty-six adult subjects were eligible and recruited in the present study. Although experimental group exhibited more severe infection, no significant differences of the postoperative symptoms or periodontal parameters was found between the 2 groups (P > 0.05). All patients were examined respectively using CBCT at baseline (T0), postoperative 1 week (T1) and 12 months (T2). Both alveolar bone height and width increased from T0 to T1 (P < 0.001) and then reduced from T1 to T2 (P < 0.001) in both groups. However, significant bone augmentation was achieved in each group from T0 to T2 (P < 0.001). Furthermore, the vertical alveolar bone augmentation in the experimental group increased significantly than that in the traditional surgery (P < 0.05).ConclusionsCompared with traditional PAOO surgery, the periosteum-covered technique provides superior graft stabilization and satisfactory vertical bone augmentation in the labial mandibular anterior area.

Project description:BackgroundPercutaneous endoscopic gastrostomy (PEG) is the most commonly used access for long-term enteral nutrition. Only a few studies report the prevalence and epidemiology of PEG placements. No previous data concentrated on the healthcare system issues influencing the qualification rates and professional nutritional support for individuals with PEG.MethodsWe conducted a retrospective nationwide analysis of PEG placements in Poland from 2010 to 2020. The central data on ICD-10 coding of adult patients with PEG reported to the insurance company were used for the analysis of general and regional prevalence, age, and primary and secondary diseases. Rates of patients with home enteral nutrition (HEN) were calculated with a special focus on patients with cancer. A secondary aim was to determine the causes of regional disparities among administrative regions.ResultsA total number of 90,182 PEGs were placed during the observation period. The number was increasing each year with statistical significance. Malnutrition, dysphagia, and cardiorespiratory/metabolic diseases were the most frequently reported primary diseases. A total of 11.98% of all patients were diagnosed with cancer; 49.9% of oncological patients suffered from head and neck cancer (HNC) and 19.9% from esophageal cancer. In total, 6.61% of HNC and 27.46% of patients with esophageal cancer from the Polish National Cancer Registry (NCR) had PEG. The rates of patients in more advanced ages (65-74 and over 85 years) were growing and decreased in younger groups (18-24, 45-54, and 55-64 years). Overall, 27.6% of all (11.86% of cancer) patients with PEG were reimbursed HEN. A high number of patients in nursing care facilities, lower education of citizens, and lower number of hospital beds were associated with more PEG insertions in the administrative regions.ConclusionThe number of PEG placements has been increasing, particularly in the elderly. Systemic solutions must be found to address the problems of regional disparities in PEG's prevalence as well as the lack of inclusion criteria for nutritional support.

Dataset Information

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

Publications

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

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