NCT01722279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
414

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2012

Completed
Last Updated

November 6, 2012

Status Verified

November 1, 2012

Enrollment Period

1.7 years

First QC Date

November 2, 2012

Last Update Submit

November 2, 2012

Conditions

Keywords

bariatric surgerylong-term outcomesobesity

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Relationship satisfaction

    At least 5 years post-surgery

  • Substance abuse and behavioral excesses

    At least 5 years post-surgery

  • Physical Health Problems

    At least 5 years post-surgery

  • Weight history

    At least 5 years post-surgery

  • Satisfaction with surgery

    At least 5 years post-surgery

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

Also known as: roux-en-y gastric bypass, gastric band, biliopancreatic diversion with duodenal switch, vertical banded gastroplasty
Bariatric surgery patients, at least 5 years post-surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Bariatric surgery patients of the St. Vincent Bariatric Center of Excellence who had surgery at least 5 years before the survey was administered.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent Carmel Hospital Bariatric Center of Excellence

Carmel, Indiana, 46032, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Bariatric SurgeryGastric BypassBiliopancreatic DiversionGastroplasty

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, OperativeGastroenterostomyAnastomosis, SurgicalDigestive System Surgical ProceduresBiliary Tract Surgical Procedures

Study Officials

  • Leslie M Schuh, PhD

    St. Vincent Carmel Bariatric Center of Excellence

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2012

First Posted

November 6, 2012

Study Start

July 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

November 6, 2012

Record last verified: 2012-11

Locations