## Protocol Section
### Identification Module
**NCT ID:** NCT01722279

**Brief Title:** The Long Term Impact of Bariatric Surgery on Quality of Life

**Official Title:** The Long Term Impact of Bariatric Surgery on Quality of Life

#### Organization Study ID Info
**ID:** 10070
#### Organization
**Class:** OTHER
**Full Name:** Ascension St. Vincent Carmel Hospital
### Status Module
#### Completion Date
**Date:** 2012-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-11-06

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-11-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-03

**Type:** ACTUAL

#### Start Date
**Date:** 2010-07

**Status Verified Date:** 2012-11

#### Study First Post Date
**Date:** 2012-11-06
**Type:** ESTIMATED
**Study First Submit Date:** 2012-11-02
**Study First Submit QC Date:** 2012-11-02
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ascension St. Vincent Carmel Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Obesity

**Keywords:**

- bariatric surgery

- long-term outcomes

- obesity

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 414

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: Bariatric surgery

**Label:** Bariatric surgery patients, at least 5 years post-surgery

### Interventions

#### Intervention 1

**Arm Group Labels:**

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

**Name:** Bariatric surgery

**Other Names:**

- roux-en-y gastric bypass

- gastric band

- biliopancreatic diversion with duodenal switch

- vertical banded gastroplasty

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Flourishing Scale (Diener et al, 2009)

**Time Frame:** 5 or more years after bariatric surgery

**Measure:** Satisfaction with Life Scale (Diener et al, 1985)

**Time Frame:** 5 or more years after bariatric surgery

#### Secondary Outcomes

**Measure:** Relationship satisfaction

**Time Frame:** At least 5 years post-surgery

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

**Measure:** Substance abuse and behavioral excesses

**Time Frame:** At least 5 years post-surgery

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

**Measure:** Physical Health Problems

**Time Frame:** At least 5 years post-surgery

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

**Measure:** Weight history

**Time Frame:** At least 5 years post-surgery

**Measure:** Satisfaction with surgery

**Time Frame:** At least 5 years post-surgery

**Measure:** Contact with Bariatric Center caregivers

**Time Frame:** At least 5 years post-surgery

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Carmel

**Country:** United States

**Facility:** St. Vincent Carmel Hospital Bariatric Center of Excellence

**State:** Indiana

**Zip:** 46032

#### Overall Officials

**Official 1:**

**Affiliation:** St. Vincent Carmel Bariatric Center of Excellence

**Name:** Leslie M Schuh, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: HIGH

- As Found: Quality of Life

### Misc Info Module

- Version Holder: 2024-05-24
