Impact of Wearing a Support Garment Following Parietal Gastrectomy

Laval University

Status: Terminated

Conditions: Obesity; Obesity, Morbid

Treatments: Device: support garment; Procedure: sleeve gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04938310

Bodynov

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Sleeve gastrectomy

Treatment:

Procedure: sleeve gastrectomy

Support garment group

Experimental group

Description:

Sleeve gastrectomy followed by a period of 12-month with a support garment

Treatment:

Procedure: sleeve gastrectomy

Device: support garment