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Outcomes After Weight Loss Surgery in Low-Risk Patients

Evaluation of Patient Reported Outcomes After Weight Loss Surgery in Low-Risk Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05699083
Enrollment
20
Registered
2023-01-26
Start date
2022-03-11
Completion date
2026-01-12
Last updated
2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Weight Loss

Keywords

Outcomes

Brief summary

The purpose of this research is to determine patient-reported outcomes after weight loss surgery, including changes in health, mood, quality of life, health satisfaction, and emotional health, in low-risk patients. Weight loss surgery has been well studied for patients with body mass index (BMI) 35 kg/m\^2 or more and those with weight-related medical problems who have a BMI 30 kg/m\^2 or more. However, outcomes after weight loss surgery in patients with BMI under 35 kg/m\^2 and without co-morbidities have not been well studied.

Detailed description

The purpose of this research is to determine patient-reported outcomes after weight loss surgery in low-risk patients. Weight loss surgery has been well-studied for patients with body mass index (BMI) 35 kg/m\^2 or more and those with weight-related medical problems who have a BMI 30 kg/m\^2 or more. Weight-related medical problems, also called co-morbidities, can include diabetes mellitus, hypertension, sleep apnea, and degenerative joint diseases. The surgery is considered safe and effective. Outcomes after weight loss surgery in patients with BMI under 35 kg/m\^2 and without co-morbidities have not been well studied. The investigators' purpose is to study patient-reported outcomes after weight loss surgery in patients with BMI between 30 kg/m\^2 and 34.5 kg/m\^2 without co-morbidities. These include changes in health, mood, quality of life, health satisfaction, and emotional health.

Interventions

OTHERBody Image/Self-Esteem Questionnaires

Pre-operation and post-operation questionnaires to assess factors including but not limited to body image, quality of life, and self-esteem.

Sponsors

Dr. Feiz & Associates
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Pre-post interventional study

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Patients with BMI between 30 kg/m2 and 34.5 kg/m2 without co-morbidities who are medically cleared to undergo cosmetic weight loss surgery. * Written informed consent obtained from the subject or the subject's legal representative and the ability for the subject to comply with the requirements of the study.

Exclusion criteria

* Patients who are pregnant. * Patients with BMI below 30 kg/m2. * Patients with BMI above 34.5 kg/m2. * Patients who have co-morbidities including, but not limited to, diabetes mellitus, hypertension, sleep apnea, and degenerative joint disease. * Patients who are not medically cleared to undergo weight loss surgery.

Design outcomes

Primary

MeasureTime frameDescription
Change in Perception of General Health0, 1, 3, 6, 12 monthsA survey will be administered to determine changes in one's self-assessed general health.
Change in Perception of Body Image0, 1, 3, 6, 12 monthsSurveys will be administered to determine changes in one's self-assessed body image.
Change in Perception of Quality of Life0, 1, 3, 6, 12 monthsSurveys will be administered to determine changes in one's self-assessed quality of life.

Countries

United States

Contacts

Primary ContactNegin Fadaee, BS MPH
negin@drfeiz.com818-326-5515

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026