Impact of Wearing a Support Garment Following Parietal Gastrectomy

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Wearing a Support Garment on Mobility, Functional Capacity, Self-esteem, Quality of Life and Skin Maceration Following Parietal Gastrectomy

Conditions
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Obesity, Obesity, Morbid

Intervention / Treatment
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* Procedure: sleeve gastrectomy
* Device: support garment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Sleeve gastrectomy | Procedure: sleeve gastrectomy<br>* sleeve gastrectomy<br>|
| Experimental: Support garment group<br>Sleeve gastrectomy followed by a period of 12-month with a support garment | Procedure: sleeve gastrectomy<br>* sleeve gastrectomy<br>Device: support garment<br>* A custom made support garment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess skin | Excess skin measured with the Iglesias scale, scores are from 1 to 5, higher score means a worse excess skin | From baseline to 12 month following sleeve gastrectomy | 
| Skin maceration | maceration evaluated with an in-house questionnaire reported as presence or absence of skin maceration | From baseline to 12 month following sleeve gastrectomy | 
| Skin infection | infection evaluated with an in-house questionnaire reported as presence or absence of skin infection | From baseline to 12 month following sleeve gastrectomy | 
| Impact of excess skin | 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. | From baseline to 12 month following sleeve gastrectomy | 
| Physical activity | Physical activity evaluated by wearing an activity monitor | From baseline to 12 month following sleeve gastrectomy | 
| Physical activity | Global Physical Activity Questionnaire | From baseline to 12 month following sleeve gastrectomy | 
| Lower back pain | Quebec back pain scale, scores are from 0 to 100, higher score means greater difficulty in carrying out activities due to low back pain | From baseline to 12 month following sleeve gastrectomy | 
| Self esteem | Rosenberg self esteem scale, scores are from 10 to 40, higher score mean a stronger self esteem | From baseline to 12 month following sleeve gastrectomy | 
| Self esteem related to physical appearance | 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. | From baseline to 12 month following sleeve gastrectomy | 
| Body image | 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. | From baseline to 12 month following sleeve gastrectomy | 
| Body image | body shape questionnaire, scores are from 34 to 204, higher score means worse feeling about the appearance. | From baseline to 12 month following sleeve gastrectomy | 
| Body image | 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 | From baseline to 12 month following sleeve gastrectomy | 
| Severity of depression symptoms | Beck Depression Inventory II questionnaire, scores are from 0 to 63, higher score means more severe depressive symptoms. | From baseline to 12 month following sleeve gastrectomy | 
| Anxiety | 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. | From baseline to 12 month following sleeve gastrectomy | 
| Social Physique Anxiety | Social Physique Anxiety Scale, scores are from 12 to 60, higher score means more anxiety | From baseline to 12 month following sleeve gastrectomy | 
| Quality of life | 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 | From baseline to 12 month following sleeve gastrectomy | 
| marital satisfaction | Dyadic adjustment scale, scores are from 0 to 151, higher score indicates a higher level of marital functioning | From baseline to 12 month following sleeve gastrectomy | 
| social ideals of physical appearance | 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 | From baseline to 12 month following sleeve gastrectomy | 
| gastroesophageal reflux disease | GastroEsophageal Reflux Disease Score, scores are from 0 to 96, higher score indicates worse gastroesophageal reflux symptoms | From baseline to 12 month following sleeve gastrectomy | 
| adherence in wearing the support garment | 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. | From baseline to 12 month following sleeve gastrectomy | 
| persistence in wearing the support garment | 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. | From baseline to 12 month following sleeve gastrectomy | 
| Body composition | body fat composition assessed by impedance | From baseline to 12 month following sleeve gastrectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric surgery