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The Long Term Impact of Bariatric Surgery on Quality of Life

NCT ID: NCT01722279

Last Updated: 2012-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

414 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-03-31

Brief Summary

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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

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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

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Obesity

Keywords

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bariatric surgery long-term outcomes obesity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Bariatric surgery

Intervention Type PROCEDURE

Interventions

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Bariatric surgery

Intervention Type PROCEDURE

Other Intervention Names

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roux-en-y gastric bypass gastric band biliopancreatic diversion with duodenal switch vertical banded gastroplasty

Eligibility Criteria

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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 Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ascension St. Vincent Carmel Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leslie M Schuh, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Vincent Carmel Bariatric Center of Excellence

Locations

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St. Vincent Carmel Hospital Bariatric Center of Excellence

Carmel, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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10070

Identifier Type: -

Identifier Source: org_study_id