Clinical trial NCT04938310: Impact of Wearing a Support Garment Following Parietal Gastrectomy
Official title: Impact of Wearing a Support Garment on Mobility, Functional Capacity, Self-esteem, Quality of Life and Skin Maceration Following Parietal Gastrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Obesity, Morbid
Keywords: Bariatric surgery
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Bodynov
name: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
First posted: 2021-06-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* meeting the NIH criteria for bariatric surgery
* BMI \>= 35 kg/m2

Exclusion Criteria:

* chronic pulmonary obstructive disease
* gastric stoma
* psychiatric disease contraindicated for bariatric surgery

Primary outcomes:
measure: Excess skin
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: Skin maceration
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: Skin infection
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: Impact of excess skin
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: Physical activity
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: Physical activity
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: Lower back pain
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: Self esteem
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: Self esteem related to physical appearance
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: Body image
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: Body image
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: Body image
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: Severity of depression symptoms
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: Anxiety
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: Social Physique Anxiety
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: Quality of life
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: marital satisfaction
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: social ideals of physical appearance
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: gastroesophageal reflux disease
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: adherence in wearing the support garment
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: persistence in wearing the support garment
timeFrame: From baseline to 12 month following sleeve gastrectomy
measure: Body composition
timeFrame: From baseline to 12 month following sleeve gastrectomy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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