Impact of Wearing a Support Garment Following Parietal Gastrectomy

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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Obesity, Morbid
• Intervention / Treatment: Procedure: sleeve gastrectomy; Device: support garment

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Quebec City, Quebec, Canada, G1V 4G5
      • Criucpq-Ul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval; Bodynov

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Bariatric surgery
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Obesity, Morbid
• Other Study ID Numbers: Bodynov

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No