Impact of Wearing a Support Garment Following Parietal Gastrectomy
- Conditions
- ObesityObesity, Morbid
- Interventions
- Procedure: sleeve gastrectomyDevice: support garment
- Registration Number
- NCT04938310
- Lead Sponsor
- Laval University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- meeting the NIH criteria for bariatric surgery
- BMI >= 35 kg/m2
- chronic pulmonary obstructive disease
- gastric stoma
- psychiatric disease contraindicated for bariatric surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group sleeve gastrectomy Sleeve gastrectomy Support garment group sleeve gastrectomy Sleeve gastrectomy followed by a period of 12-month with a support garment Support garment group support garment Sleeve gastrectomy followed by a period of 12-month with a support garment
- Primary Outcome Measures
Name Time Method Impact of excess skin From baseline to 12 month following sleeve gastrectomy Sahlgrenska Excess Skin questionnaire assesses excess skin after weight loss for specific body parts and body as a hole. Inconvenience of excess skin is evaluated on a scale from 0 to 10, higher score means higher perception that the excess skin is an inconvenience.
Social Physique Anxiety From baseline to 12 month following sleeve gastrectomy Social Physique Anxiety Scale, scores are from 12 to 60, higher score means more anxiety
social ideals of physical appearance From baseline to 12 month following sleeve gastrectomy Sociocultural Attitude Towards Appearance Questionnaire-4 contains 6 subscales (internalization: thinness / low fat mass, internalization: muscular, internalization: general attractiveness, pressures: family, pressures: media, pressures: similar and other significant). Scores are from 1 to 5, higher scores indicating greater internalization and endorsement of societal appearance ideals
Body image From baseline to 12 month following sleeve gastrectomy Eating Disorders Examination Questionnaire contains subscales for restraint, eating concern, shape concern and weight concern. Each subscales and global scale scores are form 0 to 6, higher score means worse outcome
Severity of depression symptoms From baseline to 12 month following sleeve gastrectomy Beck Depression Inventory II questionnaire, scores are from 0 to 63, higher score means more severe depressive symptoms.
Anxiety From baseline to 12 month following sleeve gastrectomy State-Trait Anxiety Inventory contains 2 subscales for usual emotional state and current emotional state. Scores are from 20 to 80, higher scores means higher anxiety state.
Quality of life From baseline to 12 month following sleeve gastrectomy Laval questionnaire contains 6 subscales for symptoms, activity/mobility, personal hygiene/clothing, emotions, social interactions, and sex life. scores are from 1 to 7, higher score means higher quality of life in each domain
persistence in wearing the support garment From baseline to 12 month following sleeve gastrectomy persistence in wearing the support garment will be calculated as a percentage by reporting the number of participants who have stopped wearing the garment compared to those who have used it.
Skin maceration From baseline to 12 month following sleeve gastrectomy maceration evaluated with an in-house questionnaire reported as presence or absence of skin maceration
Excess skin From baseline to 12 month following sleeve gastrectomy Excess skin measured with the Iglesias scale, scores are from 1 to 5, higher score means a worse excess skin
Skin infection From baseline to 12 month following sleeve gastrectomy infection evaluated with an in-house questionnaire reported as presence or absence of skin infection
Lower back pain From baseline to 12 month following sleeve gastrectomy Quebec back pain scale, scores are from 0 to 100, higher score means greater difficulty in carrying out activities due to low back pain
marital satisfaction From baseline to 12 month following sleeve gastrectomy Dyadic adjustment scale, scores are from 0 to 151, higher score indicates a higher level of marital functioning
Physical activity From baseline to 12 month following sleeve gastrectomy Global Physical Activity Questionnaire
Self esteem From baseline to 12 month following sleeve gastrectomy Rosenberg self esteem scale, scores are from 10 to 40, higher score mean a stronger self esteem
Self esteem related to physical appearance From baseline to 12 month following sleeve gastrectomy Body Esteem Scale for Adolescent and Adults contains 3 subscales for weight, appearance and attribution. Scores are from 1 to 5, higher score means higher self esteem.
gastroesophageal reflux disease From baseline to 12 month following sleeve gastrectomy GastroEsophageal Reflux Disease Score, scores are from 0 to 96, higher score indicates worse gastroesophageal reflux symptoms
adherence in wearing the support garment From baseline to 12 month following sleeve gastrectomy adherence in wearing the support garment evaluated with an adherence journal. Adherence will be calculated as a percentage from the total number of days the participant wears the garment out of the total for the intervention.
Body composition From baseline to 12 month following sleeve gastrectomy body fat composition assessed by impedance
- Secondary Outcome Measures
Name Time Method