Impact of Wearing a Support Garment Following Parietal Gastrectomy

NCT ID: NCT04938310

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2021-12-01

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.

Detailed Description

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Conditions

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Obesity Obesity, Morbid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

Sleeve gastrectomy

Group Type ACTIVE_COMPARATOR

sleeve gastrectomy

Intervention Type PROCEDURE

sleeve gastrectomy

Support garment group

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

Group Type EXPERIMENTAL

sleeve gastrectomy

Intervention Type PROCEDURE

sleeve gastrectomy

support garment

Intervention Type DEVICE

A custom made support garment

Interventions

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sleeve gastrectomy

sleeve gastrectomy

Intervention Type PROCEDURE

support garment

A custom made support garment

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bodynov

UNKNOWN

Sponsor Role collaborator

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

OTHER

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

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Laurent Biertho

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Criucpq-Ul

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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Bodynov

Identifier Type: -

Identifier Source: org_study_id

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