The Long Term Impact of Bariatric Surgery on Quality of Life

Completed

• Conditions: Obesity
• Interventions: Procedure: Bariatric surgery

• Registration Number: NCT01722279
• Lead Sponsor: Ascension St. Vincent Carmel Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-11
• Study First Submitted: 2012-11-02
• Study First Submitted QC: 2012-11-02
• Last Update Submitted: 2012-11-02
• Study First Posted: 2012-11-06
• Last Update Posted: 2012-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 414

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bariatric surgery patients, at least 5 years post-surgery	Bariatric surgery	Survey participants had bariatric surgery at the St. Vincent Bariatric Center of Excellence at least 5 years before completing survey.

Primary Outcome Measures

Name	Time	Method
Flourishing Scale (Diener et al, 2009)	5 or more years after bariatric surgery
Satisfaction with Life Scale (Diener et al, 1985)	5 or more years after bariatric surgery

Secondary Outcome Measures

Name	Time	Method
Relationship satisfaction	At least 5 years post-surgery
Substance abuse and behavioral excesses	At least 5 years post-surgery	Assesses presence of alcohol or other drug use problems, excessive spending, and problematic gambling
Physical Health Problems	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.
Weight history	At least 5 years post-surgery	Assesses pre-surgery weight, current weight, and lowest post-surgical weight.
Satisfaction with surgery	At least 5 years post-surgery
Contact with Bariatric Center caregivers	At least 5 years post-surgery

Trial Locations

Locations (1)

St. Vincent Carmel Hospital Bariatric Center of Excellence; 🇺🇸 Carmel, Indiana, United States