Stopped: Study stopped prematurely by sponsor due to lack of funding following company closure
Custom-made orthopedic support equipment and abdominal-lumbar support belts offer promising potential for several aspects affecting the health and well-being of people with obesity who choose a surgical weight loss option. However, research is needed to quantitatively document their short and long term effects on a wide range of parameters related to mobility, quality of life, lower back pain and skin maceration following parietal gastrectomy. The objective of this study is to characterize the effect of a support garment in an experimental design where a subgroup of participants will be randomized and followed for the first 12 months after a gastrectomy. The measures will be: physical activity, lower back pain, self-esteem, quality of life, skin maceration and infections. This study will scientifically document the usefulness and effectiveness of support garments throughout the weight loss surgery process.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Excess skin
Timeframe: From baseline to 12 month following sleeve gastrectomy
Skin maceration
Timeframe: From baseline to 12 month following sleeve gastrectomy
Skin infection
Timeframe: From baseline to 12 month following sleeve gastrectomy
Impact of excess skin
Timeframe: From baseline to 12 month following sleeve gastrectomy
Physical activity
Timeframe: From baseline to 12 month following sleeve gastrectomy
Physical activity
Timeframe: From baseline to 12 month following sleeve gastrectomy
Lower back pain
Timeframe: From baseline to 12 month following sleeve gastrectomy
Self esteem
Timeframe: From baseline to 12 month following sleeve gastrectomy
Self esteem related to physical appearance
Timeframe: From baseline to 12 month following sleeve gastrectomy
Body image
Timeframe: From baseline to 12 month following sleeve gastrectomy
Body image
Timeframe: From baseline to 12 month following sleeve gastrectomy
Body image
Timeframe: From baseline to 12 month following sleeve gastrectomy
Severity of depression symptoms
Timeframe: From baseline to 12 month following sleeve gastrectomy
Anxiety
Timeframe: From baseline to 12 month following sleeve gastrectomy
Social Physique Anxiety
Timeframe: From baseline to 12 month following sleeve gastrectomy
Quality of life
Timeframe: From baseline to 12 month following sleeve gastrectomy
marital satisfaction
Timeframe: From baseline to 12 month following sleeve gastrectomy
social ideals of physical appearance
Timeframe: From baseline to 12 month following sleeve gastrectomy
gastroesophageal reflux disease
Timeframe: From baseline to 12 month following sleeve gastrectomy
adherence in wearing the support garment
Timeframe: From baseline to 12 month following sleeve gastrectomy
persistence in wearing the support garment
Timeframe: From baseline to 12 month following sleeve gastrectomy
Body composition
Timeframe: From baseline to 12 month following sleeve gastrectomy