Long-Term Follow-up of Ohio State University Medical Cent... | NCT00700843

Studies
Long-Term Follow-up of Ohio State University Medical Center (OSUMC) Bariatric Patients

NCT00700843

Sponsor

Ohio State University

Status

Terminated

Last Update Posted

May 15, 2015Estimated

Enrollment

23Actual

Phase

Not provided

Conditions

Obesity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty recruiting

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Jun 17, 2008

First Submission Date that Met QC Criteria

Jun 18, 2008

First Posted Date

Jun 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2015

Last Update Posted Date

May 15, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Obtain long-term follow-up results for bariatric patients who underwent medical management or surgery for treatment of morbid obesity by Ohio State University Medical Center (OSUMC).

Detailed Description

The purpose of this study is to obtain long-term follow-up results for bariatric patients who underwent medical management or surgery for treatment of morbid obesity by Ohio State University Medical Center (OSUMC) surgeons during the late 1970s, 1980s, and 1990s. Our hypothesis is that surgical intervention for treatment of morbid obesity leads to sustained weight loss and decreased obesity-related morbidity and mortality.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Failure to lose and maintain loss of > or equal to 50% of excess body weight will be considered failure of the bariatric surgery.		10 or more years after surgery

Secondary Outcomes

Measure	Description	Time Frame
The need for additional surgical or other intervention for treatment of morbid obesity following bariatric surgery will be considered failure of the surgery.		10 or more years after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult
Treated by OSUMC physicians for obesity
Informed Consent

Exclusion Criteria:

Informed consent not given

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Adults who participated in the bariatric program at OSUMC ten or more years ago, including bariatric surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bradley J Needleman, MD	Ohio State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ohio State University Medical Center		Columbus	Ohio	43210	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided