Impact of Wearing a Support Garment Following Parietal Gastrectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Control Group Sleeve gastrectomy |
Procedure: sleeve gastrectomy
sleeve gastrectomy
|
| Experimental: Support garment group Sleeve gastrectomy followed by a period of 12-month with a support garment |
Procedure: sleeve gastrectomy
sleeve gastrectomy
Device: support garment
A custom made support garment
|
Outcome Measures
Primary Outcome Measures
- 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 maceration [From baseline to 12 month following sleeve gastrectomy]
maceration evaluated with an in-house questionnaire reported as presence or absence of skin maceration
- 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
- 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.
- Physical activity [From baseline to 12 month following sleeve gastrectomy]
Physical activity evaluated by wearing an activity monitor
- Physical activity [From baseline to 12 month following sleeve gastrectomy]
Global Physical Activity Questionnaire
- 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
- 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.
- Body image [From baseline to 12 month following sleeve gastrectomy]
Gender-specific body-size guide is a pictorial method of assessing the perception of weight status. It consists of 10 standardized images of adults with known BMI values and is a validated body size perception tool. The scale is gender specific and images range from underweight (BMI <18.5) to class III obesity (BMI> = 40) with approximately a 3 point difference in BMI between the figures on the scale.
- Body image [From baseline to 12 month following sleeve gastrectomy]
body shape questionnaire, scores are from 34 to 204, higher score means worse feeling about the appearance.
- 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.
- 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
- 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
- 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
- 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
- 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.
- 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.
- Body composition [From baseline to 12 month following sleeve gastrectomy]
body fat composition assessed by impedance
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Laval University
- Bodynov
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Bodynov