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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: Bariatric surgery

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 Type: Observational
• Enrollment (Actual): 414

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Other Names: roux-en-y gastric bypass; gastric band; biliopancreatic diversion with duodenal switch; vertical banded gastroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Relationship satisfaction		At least 5 years post-surgery
Substance abuse and behavioral excesses	Assesses presence of alcohol or other drug use problems, excessive spending, and problematic gambling	At least 5 years post-surgery
Physical Health Problems	Assesses presence of various obesity-related health problems including diabetes, hypertension, heart disease, stroke, hich cholesterol, sleep apnea, joint pain, etc.	At least 5 years post-surgery
Weight history	Assesses pre-surgery weight, current weight, and lowest post-surgical weight.	At least 5 years post-surgery
Satisfaction with surgery		At least 5 years post-surgery
Contact with Bariatric Center caregivers		At least 5 years post-surgery

Collaborators and Investigators

• Sponsor: Ascension St. Vincent Carmel Hospital
• Investigators: Principal Investigator: Leslie M Schuh, PhD, St. Vincent Carmel Bariatric Center of Excellence

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: November 2, 2012
• First Submitted That Met QC Criteria: November 2, 2012
• First Posted (Estimate): November 6, 2012

Study Record Updates

• Last Update Posted (Estimate): November 6, 2012
• Last Update Submitted That Met QC Criteria: November 2, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: obesity; bariatric surgery; long-term outcomes
• Other Study ID Numbers: 10070 (Other Identifier: CTEP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No