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CompletedNCT01722279Updated Nov 6, 2012

The Long Term Impact of Bariatric Surgery on Quality of Life

An observational study in Obesity, sponsored by Ascension St. Vincent Carmel Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-06.

Sponsored by Ascension St. Vincent Carmel Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
414
Ages
18 Years and older
Sex
All
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Study summary

The primary purpose of this study is to examine the breadth, nature, and factors affecting the long term changes in physical and psychological health and quality of life (QOL) following bariatric surgery. Data will be gathered via electronic survey (SurveyMonkey), postal mail, or phone, or using a standardized questionnaire expected to last 25-35 minutes. Archival data available from patient medical records will also be gathered.

Read the detailed description

Information from existing databases and medical records will be used to obtain a list of phone numbers for persons who had roux-en-y bariatric surgery at the SVBCE five or more years ago at the St. Vincent Bariatric Center of Excellence (SVBCE. The interview includes scripts that the caller will use to recruit subjects in either direct conversation, in voice mail or by leaving a message. Recruitment will cease after 400 complete post pilot interviews are obtained.

The interview covers topics related to physical and psychological health and quality of life. The number of questions asked will vary from subject to subject since some questions are asked only if a prior question is answered affirmatively. For example, if a subject responds "yes" when asked "have you had plastic surgery?" the subject is then asked what type of procedure they had. The topics covered are as follows: weight, current health, post surgery complications, relationships, work, cross addiction, mental health, diet, television viewing, exercise, and life satisfaction.

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Conditions studied

  • Obesity

Keywords

  • bariatric surgery
  • long-term outcomes
  • obesity
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In context

Lead sponsor

Ascension St. Vincent Carmel Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Bariatric surgery patients of the St. Vincent Bariatric Center of Excellence who had surgery at least 5 years before the survey was administered.

Inclusion criteria

  • Bariatric surgery patients of the St. Vincent Bariatric Center of Excellence who had surgery at least 5 years before the survey was administered.

Exclusion criteria

Exclusion Criteria:

  • Patients having bariatric surgery at facilities other than St. Vincent Bariatric Center.
  • Patients who had bariatric surgery less than 5 years before the survey period.
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
414 participants (actual)

Groups and cohorts

  • Bariatric surgery patients, at least 5 years post-surgery

    Survey participants had bariatric surgery at the St. Vincent Bariatric Center of Excellence at least 5 years before completing survey.

    Procedure: Bariatric surgery

Interventions

  • ProcedureBariatric surgery

    Also known as: roux-en-y gastric bypass, gastric band, biliopancreatic diversion with duodenal switch, vertical banded gastroplasty

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What researchers measure

Primary outcomes

  1. Flourishing Scale (Diener et al, 2009)

    Time frame: 5 or more years after bariatric surgery

  2. Satisfaction with Life Scale (Diener et al, 1985)

    Time frame: 5 or more years after bariatric surgery

Secondary outcomes

  1. Relationship satisfaction

    Time frame: At least 5 years post-surgery

  2. Substance abuse and behavioral excesses

    Assesses presence of alcohol or other drug use problems, excessive spending, and problematic gambling

    Time frame: At least 5 years post-surgery

  3. Physical Health Problems

    Assesses presence of various obesity-related health problems including diabetes, hypertension, heart disease, stroke, hich cholesterol, sleep apnea, joint pain, etc.

    Time frame: At least 5 years post-surgery

  4. Weight history

    Assesses pre-surgery weight, current weight, and lowest post-surgical weight.

    Time frame: At least 5 years post-surgery

  5. Satisfaction with surgery

    Time frame: At least 5 years post-surgery

  6. Contact with Bariatric Center caregivers

    Time frame: At least 5 years post-surgery

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Study locations

1 site
  • St. Vincent Carmel Hospital Bariatric Center of Excellence
    Carmel, Indiana 46032, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01722279
Lead sponsor
Ascension St. Vincent Carmel Hospital
Responsible party
Sponsor
First posted
Nov 6, 2012
Start date
Jul 2010
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Nov 6, 2012

Study contacts

Leslie M Schuh, PhD
principal investigator · St. Vincent Carmel Bariatric Center of Excellence

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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