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OpenTrials
Completed

NCT Number: NCT01722279

The Long Term Impact of Bariatric Surgery on Quality of Life

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Vincent Carmel Hospital Bariatric Center of Excellence

Carmel, Indiana, 46032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

bariatric surgery

Procedure

Other names: roux-en-y gastric bypass, gastric band, biliopancreatic diversion with duodenal switch, vertical banded gastroplasty

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

    Time frame: At least 5 years post-surgery

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

  3. Physical Health Problems

    Time frame: At least 5 years post-surgery

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

  4. Weight history

    Time frame: At least 5 years post-surgery

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

  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

Sponsors and collaborators

Lead sponsor

Ascension St. Vincent Carmel Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 6, 2012
Registry last updated
Nov 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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