Clinical trial NCT01722279: The Long Term Impact of Bariatric Surgery on Quality of Life
Official title: The Long Term Impact of Bariatric Surgery on Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: bariatric surgery
long-term outcomes
obesity
Lead sponsor: Ascension St. Vincent Carmel Hospital
Sponsor class: OTHER
First posted: 2012-11-06
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Flourishing Scale (Diener et al, 2009)
timeFrame: 5 or more years after bariatric surgery
measure: Satisfaction with Life Scale (Diener et al, 1985)
timeFrame: 5 or more years after bariatric surgery
Secondary outcomes:
measure: Relationship satisfaction
timeFrame: At least 5 years post-surgery
measure: Substance abuse and behavioral excesses
timeFrame: At least 5 years post-surgery
measure: Physical Health Problems
timeFrame: At least 5 years post-surgery
measure: Weight history
timeFrame: At least 5 years post-surgery
measure: Satisfaction with surgery
timeFrame: At least 5 years post-surgery
measure: Contact with Bariatric Center caregivers
timeFrame: At least 5 years post-surgery
Other outcomes:
Locations:
city: Carmel
country: United States
facility: St. Vincent Carmel Hospital Bariatric Center of Excellence
state: Indiana
Study officials:
affiliation: St. Vincent Carmel Bariatric Center of Excellence
name: Leslie M Schuh, PhD
role: PRINCIPAL_INVESTIGATOR
References: